Internal fixation implants for intracapsular hip fractures in adults

Martyn J Parker; Kurinchi Selvan Gurusamy

doi:10.1002/14651858.CD001467

. 2001 Oct 23;2001(4):CD001467. doi: 10.1002/14651858.CD001467

Internal fixation implants for intracapsular hip fractures in adults

Martyn J Parker ^1,^✉, Kurinchi Selvan Gurusamy ²

Editor: Cochrane Bone, Joint and Muscle Trauma Group

PMCID: PMC8406930 PMID: 11687113

Abstract

Background

Numerous different implants with screws, pins and side plates have been used for the internal fixation of intracapsular hip fractures.

Objectives

To determine from randomised trials which implant is superior for the internal fixation of intracapsular proximal femoral fractures.

Search methods

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (13 September 2010), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2010, Issue 3), MEDLINE (1950 to August week 5, 2010), EMBASE (1980 to 2010 Week 36), and other sources.

Selection criteria

Randomised and quasi‐randomised trials comparing different implants for the internal fixation of intracapsular hip fractures in adults.

Data collection and analysis

Two review authors independently assessed trial quality, by use of an 11 item scale, risk of bias relating to sequence generation and allocation concealment, and extracted data. Additional information was sought from trialists. After grouping by implant type, comparable groups of trials were subgrouped and where appropriate, data were pooled using the fixed‐effect model or, where there was significant heterogeneity, the random‐effects model.

Main results

There are now 30 studies involving 6334 participants (6339 fractures) included in this review, which was published in 2011. There was considerable variation in the quality of trial methodology and generally inadequate reporting of methods and trial findings. Allocation concealment was confirmed in one trial only. The main outcome measures reported were fracture healing complications, re‐operations and mortality. The reporting of functional outcomes was particularly poor.

Few trials tested the same comparison. Most of the results for the 25 separate comparisons, frequently tested within one trial only, showed no statistically significant differences between the two implants under test. It was noted that the more rare findings of favourable results were often for implants developed within the same institutions as the trial. There was a consistent finding of less avascular necrosis with the sliding hip screw in comparison with five different types of cancellous screws but there was no significant difference found for re‐operations. Additionally, the sliding hip screw was found to take longer to insert and to have an increased operative blood loss compared with multiple screws or pins.

Authors' conclusions

No clear conclusions can be made on the choice of implant for internal fixation of intracapsular fractures from the available evidence within randomised trials.

Plain language summary

Different implants used to fix certain types of hip fractures

Many different types of implants are used to fix fractures of the hip, which are close to the hip joint (intracapsular fractures). Implants are used to stabilise the bone during healing thereby reducing the chance of the bones slipping out of line. They consist of either screws or pins and may have an additional side plate attached, which is fixed to the bone.

This review of randomised controlled trials included 30 studies involving more than 6000 participants. Most of the trials were poorly reported and had flaws in their methods that could have affected their results. Few trials tested the same comparison. Most of the results for the 25 separate comparisons, frequently tested within one trial only, failed to show that one implant was better than the other under comparison. There was a consistent finding of one serious complication (avascular necrosis) with the sliding hip screw in comparison with five different types of cancellous screws. However, this was not reflected in a decrease in re‐operations for this group. Additionally, the sliding hip screw was found to take longer to insert and to have an increased operative blood loss compared with multiple screws or pins.

This review found no evidence from trials undertaken so far that there were any major differences between different implants in patient survival or complications related to the operation.

Background

Proximal femoral fractures or, as they are more generally termed, 'hip fractures', can be subdivided into intracapsular fractures (those occurring proximal to the attachment of the hip joint capsule to the femur) and extracapsular (those occurring distal to the hip joint capsule). Intracapsular fractures can be further subdivided into those which are displaced and those which are essentially undisplaced. Undisplaced fractures include those termed impacted or adduction fractures. Many other subdivisions and classification methods exist for intracapsular fractures but these have not been shown to be of reliable clinical usefulness (Parker 1993).

Intracapsular hip fractures are generally managed surgically, either by fixing the fracture using various implants and thereby retaining the femoral head, or by replacing the femoral head with a prosthesis. The latter option is not considered in this review. The rationale for operative treatment of intracapsular fractures is to reduce the risk of the fracture displacing, for undisplaced fractures, and to maintain fracture reduction for displaced fractures. Surgery entails passing single or multiple screws or pins across the fracture site. For displaced fractures the fracture must first be reduced, which may be achieved either by an open or closed reduction.

Numerous implants have been developed over time for the internal fixation of the fracture. Tronzo identified over 100 in 1974 (Tronzo 1974). These implants are inserted under X‐ray guidance using either an open or percutaneous procedure. Implants may be divided into those which are smooth (pins) and those which are threaded (screws). The type of threads used on screws may vary from narrow to wide and deep. In addition, the proportion of the screw which is threaded may vary from the tip only to the entire length. The number of pins or screws inserted across the fracture can vary from one to in excess of 10, depending on the size of the implant used. Screws or pins may also be connected to a side plate which is then fixed with screws to the side of the femur. Another variation on implant design is a small metal 'tongue' which is pushed out of the tip of a nail into the subchondral bone of the femur.

Examples of single nails are the Smith‐Petersen nail, Thornton nail and Rydell four‐flanged nail. Examples of a single nail with a side plate are the Holt, Jewett nail plate, Massie nail, McLaughlin nail plate, Pugh nail and Thornton nail plate. Of these implants, the Massie and Pugh nails have the capacity for sliding at the nail/plate junction, allowing for collapse at the fracture site. Examples of a single screw with a side plate are the sliding hip screw (SHS) and equivalent models such as the Ambi, Dynamic, or Richards' screws. These implants all have the capacity for sliding at the screw/plate junction.

Examples of implants with a 'tongue', which can be extruded from its tip, are the Rydell four‐flanged nail and Hansson pins. Examples of implants that are normally used in pairs are Garden screws, Hansson pins, Richards' screws, Tronzo (VLF) screws, Uppsala/Olmed screws, von Bahr screws, and Ullevaal screws. Examples of implants for which three are normally inserted are AO screws, Gouffon screws, Hessel pins, Mecron screws, Nystrom nails, Ullevaal screws and Scand screws.

The main fracture healing complication after internal fixation of an intracapsular fracture is the failure of the fracture to heal. This may lead to fracture displacement and is termed either 'early fracture displacement' or 'non‐union' if it occurs in the first few weeks after operation. The term 'non‐union' is also used for those fractures which fail to heal in later weeks. This normally results in the fracture displacing with loss of position of the fixation device. For this review the term non‐union refers to both those fractures which show early displacement plus those which later fail to heal. An incidence of non‐union of five to ten per cent can be expected following an undisplaced intracapsular fracture; this rises to about 20 to 40 per cent for displaced intracapsular fractures (Lu‐Yao 1994; Parker 1993).

The other main fracture healing complication is avascular necrosis (also termed segmental collapse or femoral head necrosis). This is seen as collapse of the femoral head and subsequent destruction of the hip joint. It occurs secondary to disruption of the blood supply to the femoral head. An incidence of 16 per cent for displaced intracapsular fractures has been reported (Lu‐Yao 1994).

Other fracture healing complications that may occur are backing out of the implant as the fracture collapses, fracture below or around the implant and breakage of the implant.

Objectives

To identify and summarise the evidence from randomised controlled trials of the effects of different implants for the internal fixation of intracapsular proximal femoral fractures.

Methods

Criteria for considering studies for this review

Types of studies

All randomised controlled trials comparing alternative implants. Quasi‐randomised trials (for example, allocation by alternation or date of birth) and trials in which the treatment allocation was inadequately concealed were considered for inclusion. No language restriction was applied.

Types of participants

Skeletally mature patients with an intracapsular proximal femoral fracture.

Types of interventions

Implants used for internal fixation of an intracapsular proximal femoral fracture.

Types of outcome measures

The principal outcome measure was the non‐union rate which includes early displacement of the fracture. Data for the following outcomes were sought:

a) Operative details

length of surgery (in minutes)
operative blood loss (in millilitres)
number of patients transfused
post‐operative blood transfusion (in units)
radiographic screening time (in seconds)

b) Fracture fixation complications

non‐union of the fracture within the follow‐up period (the definition of non‐union will be that used within each individual study and this outcome will include early re‐displacement of the fracture).
avascular necrosis
fracture below the implant
other surgical complications of fixation (as detailed in each study)
total fracture fixation complications (sum of the four above outcomes)
re‐operation (within the follow‐up period of the study).
superficial wound infection (infection of the wound in which there is no evidence that the infection extends beneath the deep fascia to the site of the implant)
deep wound infection (infection around the implant)
wound haematoma

c) Post‐operative complications

pneumonia
thromboembolic complications (deep vein thrombosis or pulmonary embolism)
any medical complications (as detailed in each individual study)
length of hospital stay (in days)

d) Anatomical restoration

shortening (as defined in each study)
varus deformity (as defined in each study)
external rotation deformity (> 20 degrees)

e) Final outcome measures

mortality (within the follow‐up period of the study)
pain (persistent pain at the final follow‐up assessment)
residence at final follow‐up (return to living at home, discharge location)
mobility (use of walking aids, return of mobility)
regain of activities of daily living
health related quality of life measures

Search methods for identification of studies

Electronic searches

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (13 September 2010), the Cochrane Central Register of Controlled Trials (2010, Issue 3), MEDLINE (1950 to August week 5 2010) and EMBASE (1980 to 2010 Week 36). We searched the WHO International Clinical Trials Registry Platform Search Portal, Current Controlled Trials, and the UK National Research Register (NRR) Archive (all to April 2009) to identify ongoing and recently completed trials. No language or publication restrictions were applied.

The generic search strategies for hip fracture trials run in The Cochrane Library (Wiley Online Library) and MEDLINE (2002 onwards) are shown in Appendix 1. This MEDLINE search was combined with the sensitivity‐ and precision‐maximizing version of the Cochrane Highly Sensitive Search Strategy for identifying randomized trials (Lefebvre 2009). The general search strategy for hip fracture trials in EMBASE (2002 onwards) is also shown in Appendix 1.

Searching other resources

We searched reference lists of articles and our own reference databases. We included the findings from handsearches of the British Volume of the Journal of Bone and Joint Surgery supplements (1996 to 2006), abstracts of the American Orthopaedic Trauma Association annual meetings (1996 to 2006) and American Academy of Orthopaedic Surgeons annual meetings (2004 to 2007). We also included handsearch results from the final programmes of SICOT (1996 and 1999) and SICOT/SIROT (2003), EFORT (2007) and the British Orthopaedic Association Congress (2000, 2001, 2002, 2003, 2005 and 2006). Up to 2007, we scrutinised weekly downloads of "Fracture" articles in new issues of Acta Orthopaedica Scandinavica (subsequently Acta Orthopaedica); American Journal of Orthopedics; Archives of Orthopaedic and Trauma Surgery; Clinical Orthopedics and Related Research; Injury; Journal of the American Academy of Orthopedic Surgeons; Journal of Arthroplasty; Journal of Bone and Joint Surgery (American and British Volumes); Journal of Orthopedic Trauma; Journal of Trauma; Orthopedics from AMEDEO.

Data collection and analysis

Selection of studies

Study selection was performed by one author.

Data extraction and management

Data for the outcomes listed above were independently extracted by both review authors using a data extraction form. Any differences were resolved by discussion.

Assessment of risk of bias in included studies

In the update of the review (2011), two aspects of risk of bias were assessed by one author (MJP) and reported. These were sequence generation and allocation concealment. In this assessment, incomplete or a lack of information on sequence generation or allocation concealment was judged as 'unclear' risk of bias unless the trial was quasi‐randomised, in which case both were rated 'no'.

We also independently assessed 11 aspects of methodological quality using a slightly modified scheme to that used in former versions of the review (seeTable 1). There was no masking of the study names or authors. Any differences were resolved by discussion.

1. Methodological quality assessment scheme.

Items	Scores
1. Was there an adequate method of sequence generation?	Score 1 if adequate method such as table of random numbers, shuffled envelopes, coin tossing. Score 0 if inadequate such as date of birth, patient registration number.
2. Was there clear concealment of allocation?	Score 1 if adequate such as central allocation, sequentially numbered opaque envelopes drawn consecutively. Otherwise score 0.
3. Were the outcome assessors blind to assignment status?	Score 1 if assessors of pain and function at follow‐up were blinded to treatment outcome. Otherwise score 0.
4. Were the inclusion and exclusion criteria clearly defined?	Score 1 if text states type of fracture and which patients were included and/or excluded. Otherwise score 0.
5. Were the outcomes of patients who withdrew or excluded after randomisation described and included in an intention‐to‐treat analysis?	Score 1 if yes or text states that no withdrawals occurred of patients after randomisation or if they were included separately and results included in the group to which they were allocated. Otherwise score 0.
6. Were the treatment and control groups adequately described at entry and if so were the groups well matched, or appropriate covariate adjustment made?	Score 1 if at least four admission details given (e.g. age, sex, mobility, function score, mental test score, fracture type) with either no important difference between groups or appropriate adjustment made. Otherwise score 0.
7. Were less that 5% of patients lost to follow‐up.	Score 1 if yes. Otherwise score 0.
8. Was the timing of outcome measures appropriate?	A minimum of 12 months follow‐up for all surviving patients. Score 1 if yes. Otherwise score 0.
9. Were the outcome measures clearly defined in the text with a definition of any ambiguous terms encountered?	Score 1 if yes. Otherwise score 0.
10. Were the surgeons experienced at both operations prior to commencement of the trial?	Score 1 if text states there was an introductory period or that all surgeons were experienced in both operations. Otherwise score 0.
11. Were the care programmes other than trial options identical?	Score 1 if text states they were or if this can be inferred. Otherwise score 0.

Date	Event	Description
27 June 2008	Amended	Converted to new review format.
27 August 2003	New search has been performed	For the first update in Issue 4, 2003 the following changes were made:   1. New study of Lykke 2003 included.   2. Sernbo 1986 and Jukkala‐Partio 2000 added to excluded studies.   3. Extra reference to studies of Olerud 1991 and Sorensen 1992 added.   There were no changes to the conclusions of the review.

Study ID	Item 1	Item 2	Item 3	Item 4	Item 5	Item 6	Item 7	Item 8	Item 9	Item 10	Item 11
*Thornton nail versus three Scand pins*
Dalen 1985	0	0	0	0	0	0	1	0	0	0	0
*Thornton nail versus sliding nail plate*
Frandsen 1981	0	0	0	1	0	0	0	1	1	0	1
*Sliding compression screw plate versus McLaughlin nail plate*
Svenningsen 1984	0	1	0	1	0	0	1	1	1	0	1
*Sliding hip screw versus sliding nail plate*
Nordkild 1985	0	0	0	1	1	0	1	0	1	0	1
*Sliding hip screw versus double divergent pins*
Christie 1988	0	0	0	1	1	0	0	1	1	0	1
*Sliding hip screw versus two von Bahr screws*
Paus 1986	0	0	0	1	0	1	1	1	1	0	1
*Sliding hip screw versus Gouffon screws*
Sorensen 1992	0	0	0	1	1	1	1	1	1	0	1
*Sliding hip screw versus cancellous screws*
Harper 1992	0	0	0	1	0	1	0	1	0	1	1
Madsen 1987	0	0	0	1	0	0	0	1	1	0	1
Kuokkanen 1991	0	0	0	1	1	0	1	1	1	0	0
*Sliding hip screw versus Hansson pins versus Uppsala screws*
Sorensen 1996	0	0	0	0	0	0	0	1	0	0	0
*Sliding hip screw versus two Uppsala or Olmed screws*
Benterud 1997	0	0	0	1	1	0	0	1	0	0	0
Ovesen 1997	0	0	0	0	0	0	0	1	0	0	0
*Sliding hip screw versus two Hansson pins*
Elmerson 1995	1	0	0	1	1	0	1	1	1	0	1
*Three Gouffon pins versus a Rydell four flanged nail*
Elmerson 1988	1	0	0	1	0	0	1	1	1	0	1
Wihlborg 1990	0	0	0	0	1	0	1	1	1	1	1
*Two Hansson pins versus a Rydell four flanged nail*
Holmberg 1990	0	0	0	0	1	1	1	1	1	1	1
Sernbo 1990	1	0	0	1	1	1	1	1	1	0	0
Stromqvist 1984	0	0	0	1	1	0	1	1	1	0	1
*Two Hansson pins versus two Uppsala screws*
Herngren 1992	1	0	0	1	1	0	1	1	1	1	1
Olerud 1991	0	0	0	0	0	0	1	1	1	0	1
*Two Hansson hook pins versus three Ullevaal screws*
Lykke 2003	0	1	0	1	0	1	0	1	1	1	0
*Two Hansson hook pins versus two AO screws*
Stromquist 1988	0	0	0	0	0	0	1	0	1	0	0
*Two Hansson hook pins versus three AO screws*
Mjorud 2006	0	0	1	1	0	1	0	1	1	0	1
*Three Richard screws versus two Uppsala screws*
Lagerby 1998	0	0	0	1	1	1	0	1	1	0	1
*Two von Bahr screws versus two Uppsala screws*
Rehnberg 1989	1	0	0	1	1	1	1	1	1	0	1
*Three Ullevaal screws versus two Olmed screws*
Alho 1998(a)	1	0	0	1	1	1	1	1	0	0	1
*Three Ullevaal screws versus two Tronzo screws*
Alho 1998(b)	1	0	0	1	1	1	1	1	0	0	1
*Three Ullevaal screws versus two Olmed screws*
Alho 1998(c)	1	0	0	1	1	1	1	1	0	0	1
*Three Nystrom nails versus three Scand screws*
Alberts 1989	0	0	0	1	1	0	1	1	1	0	0
*von Bahr screws versus Hessel pins versus Gouffon screws*
Lindequist 1989	0	0	0	0	0	1	1	1	1	0	1
*Three short thread AO screws versus three long threaded AO screws*
Parker 2010	1	0	0	1	1	1	1	1	1	1	1

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All fracture healing complications	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2 Re‐operations	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	Statistical method	Effect size
1 Non‐union	1	Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2 Avascular necrosis	1	Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3 All fracture healing complications	1	Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐union	4	462	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.57, 1.57]
1.1 Sliding hip screw versus two Uppsala/Olmed screws	1	225	Risk Ratio (M‐H, Random, 95% CI)	1.34 [0.89, 2.03]
1.2 Sliding hip screw versus two von Bahr screws	1	131	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.55, 1.76]
1.3 Sliding hip screw versus three Gouffon screws	1	73	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.28, 1.05]
1.4 Sliding hip screw versus three cancellous screws	1	33	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Avascular necrosis	5	565	Risk Ratio (M‐H, Fixed, 95% CI)	0.62 [0.38, 1.01]
2.1 Sliding hip screw versus two Uppsala/Olmed screws	1	225	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.38, 1.65]
2.2 Sliding hip screw versus two von Bahr screws	1	131	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.23, 1.53]
2.3 Sliding hip screw versus three Gouffon screws	1	73	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.13, 1.66]
2.4 Sliding hip screw versus three cancellous screws	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.19 [0.01, 3.66]
2.5 Sliding hip screw versus four cancellous screws	1	103	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.15, 2.43]
3 All fracture healing complications	6	772	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.70, 1.05]
3.1 Sliding hip screw versus two Uppsala/Olmed screws	2	326	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.81, 1.40]
3.2 Sliding hip screw versus two von Bahr screws	1	131	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.54, 1.30]
3.3 Sliding hip screw versus three Gouffon screws	1	73	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.31, 0.87]
3.4 Sliding hip screw versus three cancellous screws	2	242	Risk Ratio (M‐H, Fixed, 95% CI)	0.60 [0.28, 1.27]
4 Re‐operations ‐ arthroplasty	5	565	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.74, 1.33]
4.1 Sliding hip screw versus two Uppsala/Olmed screws	1	225	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.76, 1.75]
4.2 Sliding hip screw versus two von Bahr screws	1	131	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.53, 1.85]
4.3 Sliding hip screw versus three Gouffon screws	1	73	Risk Ratio (M‐H, Fixed, 95% CI)	0.60 [0.32, 1.12]
4.4 Sliding hip screw versus three cancellous screws	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.19 [0.01, 3.66]
4.5 Sliding hip screw versus four cancellous screws	1	103	Risk Ratio (M‐H, Fixed, 95% CI)	2.38 [0.65, 8.70]
5 Re‐operations ‐ implant removal	5	565	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.30, 2.45]
5.1 Sliding hip screw versus two Uppsala/Olmed screws	1	225	Risk Ratio (M‐H, Random, 95% CI)	2.17 [0.56, 8.45]
5.2 Sliding hip screw versus two von Bahr screws	1	131	Risk Ratio (M‐H, Random, 95% CI)	0.20 [0.04, 0.86]
5.3 Sliding hip screw versus three Gouffon screws	1	73	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.05, 5.73]
5.4 Sliding hip screw versus three cancellous screws	1	33	Risk Ratio (M‐H, Random, 95% CI)	3.29 [0.80, 13.57]
5.5 Sliding hip screw versus four cancellous screws	1	103	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.16, 1.59]
6 Deep wound infection	4	492	Risk Ratio (M‐H, Fixed, 95% CI)	2.66 [0.63, 11.25]
6.1 Sliding hip screw versus two Uppsala/Olmed screws	1	225	Risk Ratio (M‐H, Fixed, 95% CI)	5.41 [0.26, 111.49]
6.2 Sliding hip screw versus two von Bahr screws	1	131	Risk Ratio (M‐H, Fixed, 95% CI)	1.97 [0.18, 21.20]
6.3 Sliding hip screw versus three cancellous screws	1	33	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.4 Sliding hip screw versus four cancellous screws	1	103	Risk Ratio (M‐H, Fixed, 95% CI)	2.04 [0.19, 21.80]
7 Mortality	5	671	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [0.83, 1.89]
7.1 Sliding hip screw versus two Uppsala/Olmed screws	1	225	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.49, 2.40]
7.2 Sliding hip screw versus two von Bahr screws	1	131	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.19, 1.55]
7.3 Sliding hip screw versus three Gouffon screws	1	73	Risk Ratio (M‐H, Fixed, 95% CI)	2.53 [1.09, 5.86]
7.4 Sliding hip screw versus three cancellous screws	2	242	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [0.61, 2.95]
8 Pain at follow‐up	2	298	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.58, 1.12]
8.1 Sliding hip screw versus two Uppsala/Olmed screws	1	225	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.55, 1.62]
8.2 Sliding hip screw versus three Gouffon screws	1	73	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.48, 1.01]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Re‐operations ‐ arthroplasty	2	358	Risk Ratio (M‐H, Fixed, 95% CI)	0.54 [0.30, 0.95]
2 Re‐operations ‐ implant removal	2	358	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.52, 1.70]
3 Fracture below screws (requiring re‐operation)	2	358	Risk Ratio (M‐H, Fixed, 95% CI)	2.19 [0.33, 14.53]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐union	2	423	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.65, 1.30]
2 Avascular necrosis	2	423	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.57, 2.08]
3 All fracture healing complications	2	423	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.73, 1.27]
4 Re‐operations	2	423	Risk Ratio (M‐H, Fixed, 95% CI)	1.12 [0.74, 1.71]
5 Superficial wound infection	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
6 Deep wound infection	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
7 Mortality ‐ one year	2	423	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.66, 1.94]
8 Mortality ‐ two years	2	423	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.60, 1.28]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐union	3	782	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.54, 1.58]
2 Avascular necrosis	3	782	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.28, 1.24]
3 All fracture healing complications	3	782	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.48, 1.23]
4 Re‐operations ‐ arthroplasty	3	782	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.43, 1.61]
5 Re‐operations ‐ implant removal	2	630	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.51, 1.96]
6 Mortality ‐ 2 years	2	372	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.81, 1.48]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Non‐union	4	772	Risk Ratio (M‐H, Random, 95% CI)	1.25 [0.73, 2.13]
1.1 Two Hansson pins versus two Uppsala screws	2	295	Risk Ratio (M‐H, Random, 95% CI)	2.04 [0.66, 6.24]
1.2 Two Hansson pins versus three AO screws	1	199	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.40, 1.53]
1.3 Two Hansson pins versus three Ullevaal screws	1	278	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.61, 1.49]
2 Avascular necrosis	4	772	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.43, 2.05]
2.1 Two Hansson pins versus two Uppsala screws	2	295	Risk Ratio (M‐H, Random, 95% CI)	1.49 [0.69, 3.21]
2.2 Two Hansson pins versus three AO screws	1	199	Risk Ratio (M‐H, Random, 95% CI)	1.29 [0.36, 4.66]
2.3 Two Hansson pins versus three Ullevaal screws	1	278	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.21, 1.08]
3 All fracture healing complications	5	872	Risk Ratio (M‐H, Random, 95% CI)	1.14 [0.77, 1.67]
3.1 Two Hansson pins versus two Uppsala screws	3	395	Risk Ratio (M‐H, Random, 95% CI)	1.50 [0.79, 2.84]
3.2 Two Hansson pins versus three AO screws	1	199	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.56, 1.59]
3.3 Two Hansson pins versus three Ullevaal screws	1	278	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.55, 1.13]
4 Re‐operations ‐ arthroplasty	3	587	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.52, 1.04]
4.1 Two Hansson pins versus two cancellous AO	1	110	Risk Ratio (M‐H, Fixed, 95% CI)	0.15 [0.02, 1.25]
4.2 Two Hansson pins versus three AO screws	1	199	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.43, 1.34]
4.3 Two Hansson pins versus three Ullevaal screws	1	278	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.53, 1.31]
5 Re‐operation ‐ arthroplasty or need for arthroplasty	3	587	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.58, 1.12]
5.1 Two Hansson pins versus two cancellous AO	1	110	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.29, 2.22]
5.2 Two Hansson pins versus three AO screws	1	199	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.43, 1.34]
5.3 Two Hansson pins versus three Ullevaal screws	1	278	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.53, 1.31]
6 Re‐operations ‐ implant removal	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
6.1 Two Hansson pins versus three AO screws	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Re‐operations ‐ type not specified	2	379	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.73, 1.51]
7.1 Two Hansson pins versus two Uppsala screws	1	180	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.76, 2.33]
7.2 Two Hansson pins versus three AO screws	1	199	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.54, 1.42]
8 Deep wound infection	2	458	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.13, 4.45]
8.1 Two Hansson pins versus two Uppsala screws	1	180	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.13, 4.45]
8.2 Two Hansson pins versus three Ullevaal screws	1	278	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Superficial wound infection	1	278	Risk Ratio (M‐H, Fixed, 95% CI)	1.78 [0.16, 19.43]
9.1 Two Hansson pins versus three Ullevaal screws	1	278	Risk Ratio (M‐H, Fixed, 95% CI)	1.78 [0.16, 19.43]
10 Mortality	5	882	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.68, 1.06]
10.1 Two Hansson pins versus two Uppsala screws	2	295	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.38, 1.04]
10.2 Two Hansson pins versus two cancellous AO	1	110	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.29, 3.03]
10.3 Two Hansson pins versus three AO screws	1	199	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.57, 1.33]
10.4 Two Hansson pins versus three Ullevaal screws	1	278	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.70, 1.35]

Methods	Method of randomisation: not stated   Number lost to follow‐up: 0   Length of follow‐up: 24 months
Participants	Orthopaedic unit in Stockholm, Sweden   133 patients with an intracapsular fracture.   65% of fractures were displaced   Mean age: 77 years (range 39 to 99)   % male: 30%
Interventions	Three Nystrom nails versus three Scand screws.   Nystrom nails are 6.5 mm smooth pins   Scand pins are 6.5 mm cancellous threaded screws
Outcomes	Length of surgery   Non‐union   Avascular necrosis   Screw penetration   Breakage of implant   Superficial wound infection   Deep wound infection   Mortality (one and two years)
Notes	The results for 15 patients entered in the study were not given as they had either 'early death' or were lost to follow‐up.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Not stated
Allocation concealment?	Unclear risk	Not stated

Methods	Method of randomisation: "random numbers in closed envelopes"   Number lost to follow‐up: 6/607 (1%) ‐ this is the total number for the three studies of Alho   Length of follow‐up: 24 months
Participants	Orthopaedic unit in Rogaland Central Hospital, Norway (one of three centres in a multicentre study)   191 patients with an intracapsular fracture.   % of fractures displaced: 100%   Mean age: Median 79 years (range 54 to 97)   % male: 22%
Interventions	Two Olmed screws versus three Ullevaal screws Olmed screws are the same as Uppsala screws with a 6 mm shank and 8 mm threads   Ullevaal screws are 7 mm shank and 7 mm cancellous threaded screws
Outcomes	Re‐operations ‐ arthroplasty   Re‐operations ‐ implant removal   Fracture below the screws
Notes	One of three centres in a multicentre study. Results for the three centres are presented separately and there was a significant difference in the characteristics of patients and re‐operations between centres as detailed in Alho 1998.   Patients at Ullevaal hospital were older, those at Rogaland were more likely to live in residential accommodation and more re‐operations were undertaken at Rogaland hospital
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	"Random numbers"
Allocation concealment?	Unclear risk	"Closed envelopes"

Methods	Method of randomisation: "by the surgical nurse at the time of surgery according to a table of random numbers" Number lost to follow‐up: 9(4%)   Length of follow‐up: 24 months
Participants	Orthopaedic unit in Gothenburg, Sweden   223 patients with an intracapsular fracture.   74% of fractures were displaced   Mean age: 77 years (range 18 to 98)   % male: 30%
Interventions	Three Gouffon screws versus Rydell nail   Gouffon screws are 6.5 mm cancellous screws   Rydell nail is a four flanged nail with a hook extruded at its tip
Outcomes	Length of surgery   Non‐union   Avascular necrosis   Superficial wound infection   Deep wound infection   Mortality (one and two years)
Notes	The results for 20 patients entered in the study were not given as they had died within three months of fracture. No fracture healing complications were reported in this group. In 16 cases the fracture was not reducible and these were excluded as treated by a prosthesis.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	"by the surgical nurse at the time of surgery according to a table of random numbers"
Allocation concealment?	Unclear risk	"by the surgical nurse at the time of surgery according to a table of random numbers"

Methods	Method of randomisation: "random number table"   Number lost to follow‐up: 3 (1.2%)   Length of follow‐up: mean 24 months
Participants	Orthopaedic unit in Sahlgren Hospital, Gothenburg, Sweden   222 patients with an intracapsular fracture.   55% of fractures were displaced   Mean age: 77 years (range 50 to 94)   % male: 31%
Interventions	Sliding hip screw versus two Hansson hook pins (LIH pins) Hansson hook pins are 6.5 mm diameter smooth pins with a hook which is extruded at its tip
Outcomes	Length of surgery   Non‐union   Avascular necrosis   Re‐operations for arthroplasty   Mortality (two years)
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	"random number table"
Allocation concealment?	Unclear risk	not stated

Methods	Method of randomisation: by even or odd numbers of patient record   Number lost to follow‐up: not stated   Length of follow‐up: 18 months
Participants	Orthopaedic unit in Leicester, England   209 patients with an intracapsular fracture. 83% of fractures were displaced   Mean age: 72 years (range 25 to 93)   % male: 26%
Interventions	Sliding hip screw (Ambi hip screw) versus three parallel cannulated cancellous screws (Richards Medical)
Outcomes	Fracture healing complications   Mortality ‐ 1 year
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	High risk	"the last digit of the patients accident and emergency number"
Allocation concealment?	High risk	"the last digit of the patients accident and emergency number"

Methods	Method of randomisation: by "sequence of random numbers"   Number lost to follow‐up: 5 (2.8%)   Length of follow‐up: 12 months
Participants	Orthopaedic unit in Ostersund, Sweden   180 fractures in 179 patients with an intracapsular fracture.   72% of fractures were displaced   Mean age: 78 years (range 28 to 97)   % male: 37%
Interventions	Two Uppsala screws versus two Hansson pins Uppsala screws are 8 mm cancellous screws with a 6mm shank   Hansson hook pins are 6.5 mm diameter smooth pins with a hook which is extruded at its tip
Outcomes	Length of surgery   Non‐union   Avascular necrosis   Later trochanteric fracture   Re‐operations   Local discomfort   Deep wound infection   Mortality (one year)
Notes	One fracture could not be reduced and was excluded as treated by a prosthesis.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	"Sequence of random numbers"
Allocation concealment?	Unclear risk	"Sequence of random numbers"

Methods	Method of randomisation: "in the operating theatre". Exact method not stated   Number lost to follow‐up: 5 (2.3%)   Length of follow‐up: 24 months
Participants	Orthopaedic unit in Uppsala, Sweden   220 patients with an intracapsular fracture.   65% of fractures were displaced   Mean age: 79 years (range 40 to 98)   % male: 25%
Interventions	Rydell four flanged nail versus two Hansson hook pins (LIH pins)   Rydell nail is a four flanged nail with a hook extruded at its tip   Hansson hook pins are 6.5 mm diameter smooth pins with a hook which is extruded at its tip
Outcomes	Non‐union   Avascular necrosis   Re‐operations for arthoplasty   Re‐operations for implant removal   Mortality at 2 years   Failure to return home
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	"in the operating theatre". Exact method not stated
Allocation concealment?	Unclear risk	"in the operating theatre". Exact method not stated

Methods	Method of randomisation: "in block of four using a closed envelope system. The envelopes were drawn in sequential order"   Number lost to follow‐up: 28 (10.4%)   Length of follow‐up: 12 months
Participants	Orthopaedic unit in Vasteras, Sweden   268 fractures in 266 patients with an intracapsular fracture.   72% of fractures were displaced   Mean age: 80 years (range 31 to 99)   % male: 33%
Interventions	Three Richards screws versus two Uppsala screws   Richards screws are 4.8 mm shaft and 6.86 mm thread diameter   Hansson hook pins are 6.5 mm diameter smooth pins with a hook which is extruded at its tip
Outcomes	Non‐union   Avascular necrosis   Screw penetration   Re‐operations ‐ arthroplasty   Mortality   Pain   Use of walking aids
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	"in block of four using a closed envelope system. The envelopes were drawn in sequential order"
Allocation concealment?	Unclear risk	"in block of four using a closed envelope system. The envelopes were drawn in sequential order"

Methods	Method of randomisation: "numbered sealed opaque envelopes in blocks of 50"   Number lost to follow‐up: not stated   Length of follow‐up: 24 months
Participants	Orthopaedic unit in Oslo, Norway   278 intracapsular fracture.   72% of fractures were displaced   Mean age: 82 years (range 27 to 101)   % male: 18%
Interventions	Two Hansson hook‐pins versus three Ullevaal hip screws   Hansson hook pins are 6.5 mm diameter smooth pins with a hook which is extruded at its tip   Ullevaal screws are 7 mm shank and 7 mm cancellous threaded screws
Outcomes	Non‐union and early fracture displacement   Avascular necrosis   Re‐operations ‐ arthroplasty   Superficial wound sepsis   Deep wound sepsis   Wound haematoma   Deep vein thrombosis   Pneumonia   Mortality ‐ up to two years   Pain   Return to the same residential status   Length of hospital stay (mean or median)   Drill penetration of the femoral head
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	"numbered sealed opaque envelopes in blocks of 50"
Allocation concealment?	Low risk	"numbered sealed opaque envelopes in blocks of 50"

Methods	Method of randomisation: "in blocks of 50 with sealed numbered envelopes"   Number lost to follow‐up: not stated   Length of follow‐up: 24 months
Participants	Orthopaedic unit in Lund, Sweden   199 patients with an intracapsular fracture.   65% of fractures were displaced   Mean age: 81 years (range 28 to 101)   % male: 24%
Interventions	Two Hansson hook pins versus three titanium AO cancellous screws
Outcomes	Length of surgery   Poor implant positioning   Drill penetration at surgery   Non‐union and early fracture displacement   Avascular necrosis   Re‐operations ‐ arthroplasty   Re‐operations ‐ removal   Re‐operations ‐ Girdlestone excision arthroplasty   Length of hospital stay   Mortality   Walking ability
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	"in blocks of 50 with sealed numbered envelopes"
Allocation concealment?	Unclear risk	"in blocks of 50 with sealed numbered envelopes"

Methods	Method of randomisation: "odd and even numbers"   Number lost to follow‐up: 0   Length of follow‐up: median 40 months (range 1 to 64)
Participants	Orthopaedic unit in Copenhagen, Denmark   49 patients with an intracapsular fracture   78% of fractures were displaced   Mean age: 62 years (range 32 to 86)   % male: 33%
Interventions	Sliding hip screw versus sliding nail plate   The sliding nail plate has a trifin tip and sliding can occur between this and the outer barrel similar to a sliding hip screw. The barrel is attached to a short plate using a locking bolt.
Outcomes	Non‐union   Avascular necrosis   Re‐operations   Pain   Range of movement of the hip   Use of walking aids   Bone scintigraphy
Notes	A significant difference in mean ages was noted between groups, with those allocated to the nail plate group being younger (P < 0.025)   The 1987 paper was for 35 of the patients who had bone scintigraphy performed at 6 weeks, 3, 6 and 12 months
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	High risk	"odd and even numbers were used"
Allocation concealment?	High risk	"Odd and even number were used"

PERMALINK

Internal fixation implants for intracapsular hip fractures in adults

Martyn J Parker

Kurinchi Selvan Gurusamy

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Background

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Data extraction and management

Assessment of risk of bias in included studies

1. Methodological quality assessment scheme.

Measures of treatment effect

Assessment of heterogeneity

Data synthesis

Sensitivity analysis

Results

Description of studies

Risk of bias in included studies

1.

2.

Effects of interventions

Thornton nail versus three Scand pins

1.1. Analysis.

1.2. Analysis.

Thornton nail versus sliding nail plate

2.1. Analysis.

2.2. Analysis.

2.3. Analysis.

Sliding compression screw implant versus McLaughlin nail plate

3.1. Analysis.

3.2. Analysis.

3.3. Analysis.

3.4. Analysis.

3.5. Analysis.

3.6. Analysis.

Sliding hip screw (SHS) versus sliding nail plate

4.1. Analysis.

4.2. Analysis.

4.3. Analysis.

4.4. Analysis.

SHS versus double divergent pins

5.1. Analysis.

5.4. Analysis.

SHS versus different types of cancellous bone screws

6.1. Analysis.

6.2. Analysis.

6.3. Analysis.

6.4. Analysis.

6.5. Analysis.

6.6. Analysis.

6.7. Analysis.

6.8. Analysis.

SHS versus Uppsala/ Olmed screws

SHS versus two von Bahr screws

SHS versus Gouffon screws

SHS versus three cancellous screws

SHS versus four cancellous screws

Two von Bahr screws versus Hessel pins

7.1. Analysis.

7.8. Analysis.

7.3. Analysis.

7.4. Analysis.

Methods	Method of randomisation: "single toss of a coin"   Number lost to follow‐up: 2   Length of follow‐up: 12 months
Participants	Orthopaedic unit in Peterborough, UK   432 patients with an intracapsular fracture.   44% of fractures were displaced   Mean age: 77 years (range 29 to 99)   % male: 23%
Interventions	Three 16 mm threaded 6.5 mm cannulated cancellous AO screws versus three 32 mm threaded 6.5 mm cannulated cancellous AO screws
Outcomes	Non‐union   Avascular necrosis   Fracture below the implant   Re‐operations   Pain at follow‐up   Failure to return to same residence   Failure to regain mobility   Mortality
Notes	Additional methodological and results provided by Martyn Parker in response to letter from Helen Handoll
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Randomised by "by the single toss of a coin, heads to 6.5 mm cancellous screws with short threads (16 mm) and tails to long threads (32 mm)"
Allocation concealment?	Unclear risk	Coin toss was done on the ward by surgeon (information from lead investigator)

Methods	Method of randomisation: "coded envelopes"   Number lost to follow‐up: 0   Length of follow‐up: mean 28 months (range 13 to 41)
Participants	Orthopaedic unit in Aker   131 patients with an intracapsular fracture.   100% of fractures were displaced   Mean age: 69 years (all patients aged less than 80 years. Range not stated)   % male: 18%
Interventions	Two von Bahr screws versus two sliding hip screws   von Bahr screws are 7 mm cancellous screws with a 5.5 mm shank
Outcomes	Non‐union   Avascular necrosis   Re‐operations ‐ arthroplasty   Re‐operations ‐ implant removal   Deep wound infection   Length of surgery   Mortality (during follow‐up)
Notes	Study restricted to patients aged less than 80 years
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	"after the x‐ray examinations by selecting a previously coded envelope containing direction of type of operation"
Allocation concealment?	Unclear risk	"after the x‐ray examinations by selecting a previously coded envelope containing direction of type of operation"

Methods	Method of randomisation: "a table of random numbers and they were also matched with respect to age, fracture type and living conditions"   Number lost to follow‐up: 0   Length of follow‐up: 12 months
Participants	Orthopaedic unit in Uppsala, Sweden   222 patients with an intracapsular fracture.   77% of fractures were displaced   Mean age: 80 years (range 55 to 98)   % male: 25%
Interventions	Two von Bahr screws versus two Uppsala screws   von Bahr screws are 7 mm cancellous screws with a 5.5 mm shank   Uppsala screws are 8 mm cancellous screws with a 6 mm shank
Outcomes	Non‐union   Avascular necrosis   Screw penetration   Re‐operations ‐ arthroplasty   Re‐operations ‐ implant removal   Length of surgery   Operative blood loss   Mortality (one year)   Pain   Use of walking aids   Failure to return to same residence
Notes	Study conducted in the institution were one of the methods of internal fixation was originated
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	"a table of random numbers and they were also matched with respect to age, fracture type and living conditions"
Allocation concealment?	Unclear risk	"a table of random numbers and they were also matched with respect to age, fracture type and living conditions"

Methods	Method of randomisation: even or odd date of birth   Number lost to follow‐up: 3 (3.6%)   Length of follow‐up: 4 months
Participants	Orthopaedic unit in Helsingborg, Sweden   110 patients with an intracapsular fracture.   64% of fractures were displaced   Mean age: 77 years (range 32 to 92)   % male: 25%
Interventions	Two AO screws versus two Hansson hook pins   AO screws are have 6.5 mm cancellous threads   Hansson hook pins (LIH) are 6.5 mm diameter smooth pins with a hook which is extruded at its tip
Outcomes	Re‐operation   Need for re‐operation ‐ arthroplasty   Mortality (4 months)   Bone scintimetry
Notes	Study translated from article in French courtesy of Celine Froidevaux
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	High risk	Even or odd date of birth
Allocation concealment?	High risk	Even or odd date of birth

Methods	Method of randomisation: "sealed envelopes"   Number lost to follow‐up: 0   Length of follow‐up: 24 months
Participants	Orthopaedic unit in Ljungby, Sweden   200 patients with an intracapsular fracture.   83% of fractures were displaced   Mean age: 77 years (range 46 to 100)   % male: 29%
Interventions	Three Gouffon pins versus Rydell four flanged nail Gouffon pins are 6.5 mm cancellous screws   The Rydell nail is a four flanged nail with a hook extruded at its tip
Outcomes	Non‐union   Avascular necrosis   Re‐operations   Mortality (one and two years)
Notes	Once randomised, patients were allocated to a surgeon who was familiar with the implant to which the patient had been allocated to receive
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	“randomized cards indicating the group of surgeons to which the patient was to be allocated were kept in sealed envelopes that were opened on the day of the operation”
Allocation concealment?	Unclear risk	“randomized cards indicating the group of surgeons to which the patient was to be allocated were kept in sealed envelopes that were opened on the day of the operation”

Study	Reason for exclusion
Ingwersen 1992	This prospective randomised trial was reported only as a conference abstract. The study compared 100 patients treated with either two Olmed screws or two Richards screws. Twenty‐six patients were subsequently excluded for the operation being the wrong indication (9), died (12) or lost to follow‐up (5). Follow‐up was for only three months (range two to six months). No loss of fixation was reported in the undisplaced fractures. For the displaced fracture 're‐dislocation' was reported in 14/29 of the Olmed screws and 23/31 of the Richard screws. The study was excluded as there was only a limited follow‐up and inadequate reporting of results.
Jukkala‐Partio 2000	This was a comparative study of 40 patients in which their intracapsular fracture was fixed with metallic screws and 40 patients who had their fracture fixed with three bioabsorbable screws. For undisplaced fracture non‐union occurred in 5/29 and 8/29 for the bioabsorbable screws versus the metal screws. For displaced fractures non‐union occurred in 6/11 cases for both groups. Walking ability and range of movement were reported to be better after the bioabsorbable fixation.   The study was excluded as there was no randomisation of patients.
Poulsen 1995	This is a retrospective review of 182 patients treated at one centre where one department treated the patients by sliding screw plate and the other department used the sliding hip screw. It was excluded, as it was not a randomised controlled trial.
Sernbo 1986	This randomised trial reported only as a conference abstract involved 300 patients with an intracapsular fracture randomised to either the Rydell nail or three cannulated screws. After one and two years there was 'no significant difference' in the mortality, walking capacity or social rehabilitation between the two groups. Complications of displacement, avascular necrosis and pseudarthrosis occurred in 36% of the Rydell group and 30% of the cannulated screw group, with re‐operations in 20% of the Rydell group and 16% of the screw group.   The study was excluded as because there was inadequate reporting of results within the conference abstract and no mention of the number of patients in each group.

Trial name or title	Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH): a multi‐centre randomised trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures
Methods	A multi‐centre randomised trial
Participants	Patients with an intracapsular fracture that is to be treated by internal fixation
Interventions	Comparing sliding hip screws and cancellous screws
Outcomes	Primary outcome measures: Revision surgery   Secondary outcome measures: Function, quality of life, complications, including mortality, avascular necrosis, nonunion, implant breakage or failure, implant removal after fracture healing to minimize pain, and infection.
Starting date	March 2009
Contact information	Julie Agel, MA 612‐273‐8052 (agelx001@umn.edu)
Notes	Predicted end date March 2013