Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effects (benefits and harms) of different surgical methods for treating humeral shaft fractures in adults.
Background
Description of the condition
The humeral shaft is the long middle section of the upper arm bone (humerus). Fractures of the humeral shaft account for just over one per cent of all adult fractures (Court‐Brown 2006). The annual incidence of these injuries has been reported as 10 and 14.5 per 100,000 people (Ekholm 2006; Tsai 2009). In the United States, nearly 66,000 fractures of the humeral shaft occur each year (Carroll 2012). There is a bimodal distribution for these fractures with a peak in young men resulting from high energy trauma and a larger peak in older women due to falls (Tytherleigh‐Strong 1998).
The AO classification system is widely used to describe these fractures. This includes three main categories: simple fractures (type A), wedge fractures (type B) and complex fractures (type C) (Marsh 2007). The majority of these fractures are closed fractures, where the overlying skin remains intact.
Most patients with fractures of the humeral shaft are treated conservatively (non‐surgically) (Carroll 2012). However, this can result in serious complications such as non‐union and malunion (Rutgers 2006; Sarmiento 1977; Sarmiento 2000; Zagorski 1988). In particular, fracture non‐union is challenging and costly to treat and can result in a poor result (Kanakaris 2007). Surgery is often reserved for more serious injuries such as open fracture, complex fractures, ipsilateral forearm fractures, polytrauma, vascular injury, nerve injury, significant soft tissue injury (that prevents the use of braces or casts) and failed conservative treatment (Cole 2007; Denard 2010; Idoine 2012). Surgical interventions, however, have a higher risk of complications including intraoperative fracture comminution, radial nerve palsy, postoperative infection, non‐union, delayed union, implant failure, shoulder impingement, restriction of shoulder movement and reoperation. In a Cochrane review that aimed to assess the effects of surgical versus conservative treatment for these fractures, Gosler 2012 failed to find any eligible randomised controlled trials to inform on "whether surgical intervention of humeral shaft fractures gives a better or worse outcome than no surgery".
Description of the intervention
The two main methods of surgery for humeral shaft fractures are plate fixation and intramedullary nailing. A third method is external fixation, which is used mainly for temporary stabilisation where there are serious soft‐tissue injuries or polytrauma (Carroll 2012;Walker 2011).
Open reduction, where the fracture is reduced under direct view, and internal fixation (ORIF) using a metal plate and screws has been the main surgical method for humeral shaft fractures. Three ORIF techniques are dynamic compression plate with or without lag screw fixation (typically used for simple fractures), locking compression plate techniques (typically used for osteopenic or torsionally unstable fractures) and bridging plate fixation (typically used for comminuted fractures) (Jiang 2007). A more recent development is minimally invasive plate osteosynthesis (MIPO), where the plate is inserted through a soft‐tissue incision away from the fracture site and secured on either side of the fracture (Benegas 2014; Sohn 2014; Zhiquan 2007).
The other commonly used method of fixation is intramedullary nailing, where a metal rod is inserted either from above the fracture site at the shoulder (antegrade nail) or below the fracture site at the elbow (retrograde nail) into the inner cavity (medulla) of the humerus. Intramedullary nailing is usually performed with closed reduction, where the displaced bone fragments are manipulated back into place without surgery. However, open reduction may be necessary when the fracture cannot be reduced satisfactorily. The nail is generally held in place by screws. The direction of insertion and the use of distal interlocking screw(s) are two points of debate for this technique (Garnavos 2011; Tyllianakis 2013).
How the intervention might work
Open reduction and plate fixation allows direct visualisation, anatomic reduction and rigid fixation of the fracture. It generally involves a wide surgical exposure and increases the soft‐tissue damage at the fracture site and beyond, potentially impairing healing. Of particular concern is major damage to the periosteum, the tough outer layer of bones that plays a vital role in healing. Careful dissection should help to avoid damage to the radial nerve. Fracture fixation with dynamic or locking compression plates can provide the effect of absolute stability. The dynamic compression plate is designed to compress the repositioned bone fragments together in a controlled way. The absolute stability derives from the friction between the plate and the bone (Wagner 2003). Locking compression plates are specially designed to minimise the compressive forces exerted by the plate on the bone by the screws being tightly locked in the plate. In this way the periosteum remains relatively undamaged and circulation is retained (Wagner 2003). The MIPO technique, where the plate is implanted submuscularly, uses the bridging principle and thus avoids direct fracture exposure and reduces soft‐tissue damage at the fracture site. Potential drawbacks of MIPO include difficulties in gaining a satisfactory reduction, increased length of surgery and radiation exposure, and the risk of intraoperative nerve injury (Kobayashi 2010).
The technique of intramedullary nailing provides relative but not absolute stability between fracture fragments. The intramedullary nail acts as a load‐sharing implant that maintains normal periosteal blood supply and minimises the device's impact on fracture biology (Garnavos 2011; Spiguel 2012). Even when open reduction is required, periosteal stripping can be kept to a minimum (Pickering 2002). Both surgical approaches (antegrade and retrograde) for nail insertion carry risks of further injury and complications. Disadvantages of antegrade nailing include limited rotational stability and risk of shortening and interference of shoulder function resulting in shoulder pain and limited range of motion (Kurup 2011; Scheerlinck 2002). Disadvantages of the retrograde approach are located at the elbow joint: these include a more difficult access to the intramedullary canal and risk of an iatrogenic fracture and interference of elbow function resulting in elbow pain and limited range of motion (Scheerlinck 2002). Interlocking screws to secure the nail at both the proximal and distal ends make the intramedullary nail more stable and thus help to counter the problems of rotational instability of unlocked nails. However, distal locking of antegrade nails increases radiation exposure and intraoperative time, with the additional risk of injury to neurovascular structures.
Why it is important to do this review
As noted in the Cochrane review comparing dynamic compression plating with locked intramedullary nailing for fractures of the humeral shaft, the preferred technique of surgical intervention for these fractures is open to debate (Kurup 2011). As described above, there are a variety of surgical methods and techniques available and in use, but it is presently unclear which of the different surgical options gives the best result and for which types of humeral shaft fractures. There is thus a need to systematically review the available evidence for the different types of surgical fixation in order to inform treatment choice. This review will update the review by Kurup 2011; and also examine the evidence for different types of plate fixation and intramedullary nailing.
Objectives
To assess the effects (benefits and harms) of different surgical methods for treating humeral shaft fractures in adults.
Methods
Criteria for considering studies for this review
Types of studies
We will include randomised and quasi‐randomised (method of allocating participants to a treatment which is not strictly random: e.g. by date of birth, hospital record number, alternation) controlled clinical studies evaluating surgical interventions for treating humeral shaft fractures in adults.
Types of participants
We will include adults (> 16 years old) undergoing primary surgery of open or closed humeral shaft fractures. We will exclude trials that focus primarily on the treatment of children with these fractures or adults with periprosthetic or pathological fractures. However, we will include trials that involve young children provided the proportion of young children was clearly under 10%, or separate data were available.
Types of interventions
We will compare different methods of surgical management for humeral shaft fractures. The comparisons will include the following:
Plate versus intramedullary nail fixation: this will include the comparison of any plate versus any IMN fixation, as well as specific comparisons of commonly used devices such as dynamic compression plate versus locked intramedullary nailing.
Different methods of plate fixation: this will include comparisons of dynamic compression plate versus locking compression plate; and MIPO versus conventional ORIF.
Different methods of intramedullary nailing: this will include retrograde versus antegrade nailing; and locked nailing versus unlocked nailing.
When selecting the control group of different methods of plate or IM nail not listed above, we will usually choose the implant that involves the most invasive technique or older device.
Types of outcome measures
Primary outcomes
Generic and upper‐limb‐specific validated clinical scores (e.g. DASH (Disabilities of the Arm, Shoulder and Hand) score and ASES (American Shoulder and Elbow Surgeons) score)
Health‐related quality of life measures (e.g. Short Form‐36)
Serious adverse events including complications (e.g. infection, iatrogenic radial nerve injury, non‐union, delayed union, malunion, mortality, shoulder/elbow impingement), treatment failure (e.g. participants who have undergone a non‐routine secondary surgical intervention) or long‐term or persistent pain
Secondary outcomes
Return to activities (including sport and work)
Restricted range of shoulder or elbow movement (shoulder or elbow stiffness)
Pain (visual analogue scale)
Patient satisfaction, including with cosmetic result
Constant score
Data from any other outcomes as detailed in each individual study will also be considered for inclusion.
Timing of primary outcomes measurement
Where available, we will extract available data at the following time periods: short‐term follow‐up (up to three months following treatment); intermediate follow‐up (more than three months and up to one year after the end of treatment); and long‐term follow‐up (longer than one year after the end of treatment).
Search methods for identification of studies
Electronic searches
We will search the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to present), the Cochrane Central Register of Controlled Trials (CENTRAL, current issue), MEDLINE (Ovid Online) (1946 to present) and EMBASE (Ovid Online) (1974 to present). We will also search the World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov and the ISRCTN registry for ongoing and recently completed studies. No restrictions will be applied based on language or publication status.
In MEDLINE we will combine subject‐specific terms with the sensitivity‐maximising version of the Cochrane Highly Sensitive Search Strategy for identifying randomised trials (Lefebvre 2011). Search strategies for CENTRAL, MEDLINE and EMBASE are shown in Appendix 1.
Searching other resources
We will search reference lists of articles.
Data collection and analysis
Selection of studies
Two review authors (JW and WJH) will independently check titles, abstracts and keywords from the searches to identify potentially eligible studies. The review authors will not be blinded to the names of original researchers, journals or institutions. Upon obtaining the full texts of potentially eligible trials, the same two review authors will perform independent study selection. In the case of disagreement, a consensus will be reached through discussion with, or arbitration by, another review author (JGZ).
Data extraction and management
Two review authors (JW and WJH) will independently extract the data of each trial, including trial methods, participants, interventions, outcomes and results, using a data extraction form. Each review author will independently extract all data, which will then be combined by both authors onto an agreed data extraction table to ensure that a consensus is reached through discussion. If a consensus cannot be reached, a third review author will arbitrate (JGZ).
Assessment of risk of bias in included studies
Two review authors (JW and WJH) will independently assess each included trial for risk of bias, using Cochrane's 'Risk of bias' tool (Higgins 2011). Disagreements will be resolved by discussion and where necessary, by recourse to a third review author (JGZ). The following aspects will be assessed:
Random sequence generation
Allocation concealment
Blinding of participants and personnel
Blinding of outcome assessment
Incomplete outcome data
Selective reporting
Other sources of bias: any other possible concerns about bias, such as major imbalances in baseline characteristics (e.g. age, open fractures) and performance bias resulting in major differences
According to the above assessment, the risk of bias will be categorised as low, unclear or high for each of the included studies. If differences between the ratings of the two assessors cannot be resolved through discussion, a third author (JGZ) will be asked to adjudicate.
Measures of treatment effect
We will express treatment effects as risk ratios (RR) and 95% confidence intervals (CI) for dichotomous outcomes. We will express treatment effects of continuous outcomes as mean differences (MD) and 95% CI for single studies or for two or more studies with comparable outcome measures. Standardised mean differences (SMD) will be used when primary studies express the same variable using different instruments and different units of measurement. Where appropriate, we will report the number needed to treat for an additional beneficial outcome (NNTB) with 95% CIs and the number needed to treat for an additional harmful outcome (NNTH) with 95% CIs.
Unit of analysis issues
The unit of analysis is likely to be the individual participant. For trials including adults with bilateral fractures, we will consider presenting the data of such trials only where the discrepancy between the units of analysis and randomisation is small. Sensitivity analyses will be conducted to examine the effects of pooling these trials with correctly analysed trials. Also, we will take care to avoid problems with multiple observations of the same outcome, in part by presenting data at clinically relevant time points.
Dealing with missing data
When necessary, we will seek missing data, particularly denominators and standard deviations, from the authors of the primary studies. We will perform intention‐to‐treat analyses wherever possible. Unless we can calculate missing standard deviations from standard errors, exact P values or 95% CIs, we will not impute these.
Assessment of heterogeneity
We will assess the clinical heterogeneity in terms of participants, interventions and outcomes for the included studies. Statistical heterogeneity will be assessed by visual inspection of individual forest plots and by using the I² and Chi² statistical tests. I² values will be interpreted according to Higgins 2011. Thus, an I² value of 0% to 40% "might not be important"; 30% to 60% "may represent moderate heterogeneity"; 50% to 90% "may represent substantial heterogeneity"; and 75% to 100% represents "considerable heterogeneity".
Assessment of reporting biases
Where data from at least 10 studies are available in a meta‐analysis, we will consider generating funnel plots in order to assess publication bias.
Data synthesis
When considered appropriate, we will pool results of comparable groups of trials using both the fixed‐effect and the random‐effects models. Our choice of the model to report will be guided by careful consideration of the extent of heterogeneity and whether it can be explained, in addition to other factors, such as the number and size of included studies. We will use 95% CIs throughout. We will consider not pooling data where there is considerable heterogeneity (I² > 75%) that cannot be explained by the diversity of methodological or clinical features among trials. Where it is inappropriate to pool data, we will still present trial data in the analyses or tables for illustrative purposes and will report these in the text.
Subgroup analysis and investigation of heterogeneity
Where data allow, the following subgroup analyses will be performed:
Open fracture versus closed fracture
Immediate surgery versus delayed surgery after failed conservative treatment
Under 50 years versus 50 years or over
Fractures with two fragments versus more than two fragments
We will investigate whether the results of subgroups are significantly different by inspecting the overlap of CIs and performing the test for subgroup differences available in Review Manager 2014.
Sensitivity analysis
Where possible, we plan to perform sensitivity analyses to examine various aspects of trial and review methodology, including inclusion of trials at high risk of bias (primarily, lack of allocation concealment) or where the population is poorly defined; and using fixed‐effect versus random‐effects models for pooling. A sensitivity analysis will be performed to assess the effect of missing data by repeating the analysis but excluding studies that had less than 80% follow‐up.
Assessing the quality of the evidence
We will use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach (Schünemann 2011) to assess the quality of the body of evidence for each primary outcome and, if possible, the first four secondary outcomes listed in Types of outcome measures. The quality rating 'high' is reserved for a body of evidence based on randomised controlled trials. We may 'downgrade' the quality rating to 'moderate', 'low' or 'very low' depending on the presence and extent of five factors: study limitations, inconsistency of effect, imprecision, indirectness or publication bias.
'Summary of findings' tables
Where data are sufficient, we will present the results and the quality assessments for the main comparisons in 'Summary of findings' tables (Schünemann 2011).
Acknowledgements
We acknowledge with gratitude the constructive comments and guidance provided by Helen Handoll, Mario Lenza and Mauro Gracitelli.
We thank Lindsey Elstub and Laura MacDonald for their assistance in the preparation of this protocol.
We thank Joanne Elliott for her help with developing the search strategies.
This project was supported by the National Institute for Health Research via Cochrane Infrastructure funding to the Cochrane Bone, Joint and Muscle Trauma Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.
Appendices
Appendix 1. Search strategies
CENTRAL (Wiley Online Library)
#1 MeSH descriptor: [Humeral Fractures] explode all trees #2 humor* and fracture*:ti,ab,kw (Word variations have been searched) #3 #1 or #2 #4 shaft or midshaft or diaphys*:ti,ab,kw (Word variations have been searched) #5 #3 and #4
MEDLINE (Ovid Online)
1 Humeral Fractures/ 2 (humor* and fracture*).tw. 3 1 or 2 4 (shaft or midshaft or diaphys*).tw. 5 3 and 4 6 Randomized controlled trial.pt. 7 Controlled clinical trial.pt. 8 randomized.ab. 9 placebo.ab. 10 Drug therapy.fs. 11 randomly.ab. 12 trial.ab. 13 groups.ab. 14 or/6‐13 15 exp Animals/ not Humans/ 16 14 not 15 17 5 and 16
EMBASE (Ovid Online)
1 Humerus Fracture/ 2 (humor* and fracture*).tw. 3 1 or 2 4 (shaft or midshaft or diaphys*).tw. 5 3 and 4 6 Randomized controlled trial/ 7 Clinical trial/ 8 Controlled clinical trial/ 9 Randomization/ 10 Single blind procedure/ 11 Double blind procedure/ 12 Crossover procedure/ 13 Placebo/ 14 Prospective study/ 15 ((clinical or controlled or comparative or placebo or prospective* or randomi#ed) adj3 (trial or study)).tw. 16 (random* adj7 (allocat* or allot* or assign* or basis* or divid* or order*)).tw. 17 ((singl* or doubl* or trebl* or tripl*) adj7 (blind* or mask*)).tw. 18 (cross?over* or (cross adj1 over*)).tw. 19 ((allocat* or allot* or assign* or divid*) adj3 (condition* or experiment* or intervention* or treatment* or therap* or control* or group*)).tw. 20 RCT.tw. 21 or/6‐20 22 Case Study/ or Abstract Report/ or Letter/ 23 21 not 22 24 5 and 23
What's new
| Date | Event | Description |
|---|---|---|
| 7 May 2019 | Amended | Protocol withdrawn due to lack of progress |
Contributions of authors
Jia‐Guo Zhao: conceived the review, prepared and designed the protocol and co‐ordinated the protocol process. Jia Wang, Wan‐Jie Huang and Peng Zhang: prepared the protocol.
Sources of support
Internal sources
Tianjin Hospital, China.
External sources
No sources of support supplied
Declarations of interest
None known.
Notes
This protocol was withdrawn due to lack of progress.
Withdrawn from publication for reasons stated in the review
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