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 techniques for harvesting autologous bone graft from the iliac crest in adults.
Background
Description of the condition
Bone is a highly specialised and dynamic tissue that is continually being renewed throughout life (Gemini‐Piperni 2014). However, bony voids or defects can arise in various circumstances, such as after serious fractures, fracture non‐union, infection, severe osteoporosis and bone cancer. Bone grafts and substitutes are often used to fill bony defects or provide additional structural material. Bone grafts are used extensively in trauma and orthopaedic surgery to augment bone regeneration and fracture healing; for example, by raising the articular surface of the tibia in depressed plateau fractures to restore the joint surface and improve articular congruity. Bone grafts are also used for the promotion of delayed healing (e.g. fracture non‐unions), in bone loss (e.g. to replace gaps caused by missing bone), and for fusion of joint spaces.
There are three main sources of bone graft material: autologous (harvested from the patient’s own body), allograft (from cadaveric bone, e.g. from a tissue bank) and synthetic substitutes. Autologous bone grafts, where healthy bone is extracted from another site in the person's own skeleton, have the advantages of retaining the inherent regeneration and remodelling properties of living bone in addition to being free from the risks of disease transmission and autoimmune rejection associated with allografts. A common practice amongst surgeons is to combine autologously harvested bone graft with bone graft substitutes for reconstruction of a bony defect. This technique may maximise the unique properties of autologous bone graft whilst minimising harvest volume as synthetic substitutes contribute to the bulk for reconstruction.
Autologous bone grafts may be harvested from a range of anatomical sites such as the femur and the fibula. However, the iliac crest (the curved ridge at the top of the pelvis) has been considered the "gold standard" source for bone graft procedures due to the relatively large volume of bone that can be harvested from the pelvis (Park 2013).
Autologous bone graft harvest material can be divided into three main types: cortical (the dense compact bone that forms the outer layer of the bone), cancellous (the porous inner layer of the bone composed of trabecular bone) and corticocancellous (combination of cortical and cancellous bone) (Myeroff 2011). Cancellous bone graft material is the most commonly used iliac crest bone graft (ICBG) material because of its regeneration properties reflecting the presence of osteoblasts (bone forming cells) in the trabecular bone (Khan 2005). Cortical bone graft material is often used where immediate mechanical stability is required (Finkemeier 2002). Corticocancellous bone material combines the properties of both bone types.
Description of the intervention
The surgical techniques for ICBG harvesting all involve the extraction of bone graft material from either the anterior or posterior iliac crest. The most commonly used site for harvesting is the posterior iliac crest, partly due to the larger quantities of potential bone graft material available (Ahlmann 2002; Ebraheim 2001). Subsequent to harvesting (removal of the bone graft), reconstruction or backfilling of the iatrogenic defect at the donor site may be undertaken (Chau 2012).
Since their inception, the surgical techniques used for ICBG harvest have undergone several modifications. The wide variety of surgical techniques in use today evolved to facilitate the choice of a suitable bone graft material type (e.g. cortical, cancellous or corticocancellous) and approach (e.g. the posterior iliac crest is commonly used during prone spinal surgery due to its posterior approach). Despite the diversity in surgical techniques for iliac bone graft harvest, graft retrieval can be broadly classified into trapdoor techniques, splitting techniques, window techniques and trephine extraction. These are described below. Each may be accompanied by subsequent reconstruction of the iatrogenic bony defect.
Trapdoor techniques
Trapdoor methods involve any procedure where a bone flap (or 'trapdoor') is made in the iliac crest from which subcortical bone graft is removed before the flap is replaced to restore the cortical anatomy. This method is 'open', as the cortex is intentionally split to access cancellous bone.
Splitting techniques
These comprise any procedure that uses a vertical force to create a split or fissure in the iliac crest, and include the Wolfe‐Kawamoto technique (Wolfe 1978).
Window techniques
Window techniques remove a segment of bone from the iliac crest including the cortex. This is often subcrestal in order to retain the aesthetic symmetry of the iliac crest.
Trephine extraction
Bone graft extraction using a trephine or a bone grinder to fill a trephine tube will remove a thin core of cancellous bone graft (where a hole is made in the bone by penetrating the cortex). This method has also been grouped under 'minimally invasive' ICBG harvest by many authors.
How the intervention might work
Complications after all forms of ICBG harvest are broadly divided into major and minor based upon the level of disability caused (Arrington 1996; Banwart 1995). Major complications after ICBG include major neurovascular or visceral damage, donor site (iliac wing) fracture (Oakley 2007), deep seated infection and chronic pain. Such complications often result in increased hospitalisation, economic costs and significant morbidity for the patient (Schwartz 2009). Minor complications without long term disability include donor site pain, superficial cutaneous sensory nerve impairment and superficial seroma, haematoma or infection. Thus consideration of the best surgical technique is not just the efficacy of graft extraction but needs to include the risk of iatrogenic complications and subsequent morbidity related to the donor site.
There is considerable diversity in the surgical techniques for ICBG harvest. Moreover, the literature is replete with small case series that report on one or more of a variety of methods for ICBG but, overall, there is no consensus as to the putative advantages and disadvantages of each of the main techniques.
It has been suggested that trapdoor techniques are associated with a greater admission time and analgesia requirement compared with closed methods (e.g. trephination) for ICBG (Burstein 2000; Constantinides 2008). However, where patients require repeat grafting, the trapdoor technique will allow sufficient re‐harvest of cancellous bone from the same donor site (Moed 1998). This latter point will be relevant for rarer cases in which the use of multiple graft sites needs to be avoided.
Splitting techniques, classically described by Wolfe and Kawamoto, include anatomical restoration of the iliac crest contour (Wolfe 1978). However, the reflection of the medial and lateral cortices of the ilium, inherent to the technique, cause disruption to the attachments of the fascia and the abdominal muscles; the latter are maintained in trapdoor techniques.
Window techniques tend to preserve the contour of the iliac crest, improving post‐operative cosmesis, pain and structural stability (Behairy 2001) compared with methods that disrupt the cortex of the crest. However, window methods have been abandoned by some centres in favour of minimally invasive, closed techniques (Burstein 2000).
There is some evidence that trephine extraction reduces admission time, post‐operative analgesia requirements and donor site morbidity, whilst also reducing incision length and shortening operating time compared with open techniques (Burstein 2000; Constantinides 2008; Sharma 2011). Little data exist regarding the volume and sufficiency of graft obtained and it is suspected that trephination will not be suitable for all indications.
It is unclear how donor site reconstruction, where the void is backfilled, might reduce iatrogenic morbidity but one suggestion is that it protects the donor site from adhesive scar formation (Wang 2002).
Why it is important to do this review
In 2001, it was estimated that more than 500,000 bone graft procedures were performed annually in the United States, and more than a million worldwide (Greenwald 2001). Whilst it is difficult to ascertain the precise number of procedures carried out per year for autologous bone harvesting from the iliac crest, it remains a common surgical procedure worldwide.
The harvest of bone graft from the iliac crest is associated with considerable donor site morbidity, including chronic pain, deformity and functional impairment (Chau 2012; Wang 2002). The diversity in surgical techniques for ICBG harvest presents challenges in choosing the correct technique and, despite being a common orthopaedic surgical procedure, the varying techniques of ICBG harvest have not been reviewed in terms of their morbidity and graft success. There is a need to collate and synthesise the available evidence from randomised controlled trials comparing these techniques in order enable surgeons to make more informed clinical decisions, improve patient outcomes, and reduce post‐operative morbidity.
Objectives
To assess the effects (benefits and harms) of different surgical techniques for harvesting autologous bone graft from the iliac crest in adults.
Methods
Criteria for considering studies for this review
Types of studies
We will consider all randomised and quasi‐randomised controlled trials (where the method of allocation is known but is not truly random, e.g. alternation, allocation by hospital number or date of birth) comparing two or more surgical techniques for harvesting autologous bone graft from the iliac crest.
Types of participants
Studies in which people over the age of 16 have undergone iliac crest bone graft harvesting. This will include obtaining bone grafts for treatments for acute fractures, delayed unions, and established non‐unions as well as filling bony defects from non‐traumatic causes and additional material for fusion and reconstruction. We will exclude studies if more than 10% of participants are under the age of 16 unless separate data are available for participants over 16 years of age.
For the purpose of this review, the iliac crest is defined as the superior border of the wing of the ilium and the superiolateral margin of the greater pelvis. Anteriorposteriorly the iliac crest forms from the anterior superior iliac spine to the posterior superior spine. We will include studies of techniques where the entry point to the iliac bone for bone graft harvesting is made within this anatomical site. Hence, we will exclude studies where bone graft harvesting occurs outside of the iliac crest. We will exclude studies that compare interventions for harvesting bone from multiple sites including the iliac crest unless separate data are available for the iliac crest.
Types of interventions
We will include all surgical interventions employed to extract bone from the iliac crest. We will exclude studies that present multiple methods of autologous iliac bone grafting, where separate data are not presented by surgical technique.
No single method is well established or in common use as a method for harvesting autologous bone from the iliac crests. This makes it difficult to choose a meaningful control intervention when comparing different general surgical methods. We propose a pragmatic order of comparisons based upon our views of the frequency of use of each technique as below:
Trapdoor versus window
Trapdoor versus splitting
Trapdoor versus trephine
Window versus splitting
Window versus trephine
Splitting versus trephine
We will also compare the use of donor site reconstruction versus no donor site reconstruction (including sham procedures), regardless of the primary harvest technique.
Types of outcome measures
Primary outcomes
Successful graft extraction. Success will be defined as achieving a sufficient bone graft for its intended purposes, i.e. not requiring augmentation from a second donor site or a synthetic product that was not planned pre‐operatively. Other definitions of success by the trial investigators will be considered.
Chronic donor site pain as reported by patients, as measured by any recognised pain assessment tool (e.g. using a visual analogue scale).
Persistent and serious donor site complications, such as fracture, deep infection, or hernia formation.
Secondary outcomes
Function, preferably based on validated patient‐reported outcome measures, but also objective measures and return to work or former activities.
Patient‐reported quality of life (e.g. EuroQol 5 Dimensions (EQ‐5D)).
Early complications, including major blood loss (defined as perioperative blood loss requiring blood transfusion), initial donor site pain (measured using any recognised pain assessment tool) and superficial surgical site infection.
Resourse use
We will collect economic measures such as operation time, cost of procedure and resource use.
Timing of outcome assessment
We expect that the majority of studies included in this review will report outcomes stratified into follow‐up time periods that may not be consistent between studies. For clarity, we will divide complications into early complications (any complication reported in the first three post‐operative months) and delayed complications (those reported at any time point after three months).
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) (The Cochrane Library, current issue), MEDLINE (1946 to present) and Embase (1980 to present). We will also search the WHO International Clinical Trials Registry Platform Search Portal and Clinicaltrials.gov for ongoing and recently completed trials. We will identify conference abstracts by searching the Bone & Joint Journal orthopaedic proceedings (2006 to present). We will not apply any language restrictions and will endeavour to have non‐English language studies translated when they appear to satisfy the inclusion criteria.
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 all databases are shown in Appendix 1.
Searching other resources
We will search reference lists of identified studies and related reports.
Data collection and analysis
Selection of studies
Two review authors (TEP and KH) will independently screen search results for eligible studies using the a piloted study eligibility tool that specifies the review inclusion criteria. The same two review authors will obtain the full text articles of all potentially eligible trials and consider them in relation to the inclusion and exclusion criteria stated above. A third review author (BR) will arbitrate where there is unresolved disagreement on study selection.
Data extraction and management
Two review authors (VG and DR) will independently extract data from each included study report using a pre‐piloted data collection form. We will record details of the study methods, participants, surgical techniques and outcomes. Where disagreement cannot be resolved, we will consult a third author (DM). A single author (TEP) will enter the data collected into Review Manager (RevMan) software (RevMan 2014) and be checked by a second review author (BR). We will contact study leads for further information and unpublished data if necessary.
Assessment of risk of bias in included studies
Two review authors (AC and DM) will conduct risk of bias assessments with arbitration provided by a third review author (XG) if necessary. As per Cochrane’s ‘Risk of bias’ tool (Higgins 2011), we will assess selection bias (random allocation and allocation concealment), performance bias (blinding of participants and personnel), detection bias (blinding of outcome assessment), attrition bias (incomplete outcome data), reporting bias (selective reporting) and any other potential sources of bias (e.g. significant conflict of interest amongst the authors or corporate sponsorship; evidence of marked differences in the experience of surgeons undertaking the techniques under comparison). We will consider subjective outcomes (e.g. failure of graft extraction, donor site pain) and 'hard' outcomes (e.g. complications such as infection, return to work, death, infection) separately in our assessment of blinding of outcome assessment and short and long term outcomes separately in our assessment of the completeness of outcome data.
Measures of treatment effect
For dichotomous outcome data, we will use risk ratios with 95% confidence intervals. For continuous data, such as patient‐reported functional scores, we will report mean differences with 95% confidence intervals. If studies use different instruments to measure the same continuous outcome, we will calculate standardised mean differences with 95% confidence intervals.
Unit of analysis issues
We anticipate that the unit of randomisation in the included studies will usually be the individual patient. It is feasible that some studies will report techniques involving harvest of autologous bone graft using multiple techniques and from more than one site. We will record when such cases arise and use appropriate statistical strategies such as sensitivity analyses to test the effects of including such trials. We anticipate identifying only simple parallel group designs and do not expect to encounter cross‐over trials. However, if other designs are reported (e.g. cluster‐randomised trials), we will use generic inverse variance methods to combine data where appropriate.
We will be alert to other sources of unit of analysis problems such as presenting outcomes, such as total complications, by the number of outcomes rather than participants with these outcomes.
Dealing with missing data
We will attempt to contact trial investigators to request missing data. The primary analysis will be a completed‐case analysis, i.e. excluding the missing data. However, it is possible that some studies may report substantial loss to follow‐up, the effect of which will be explored through a planned sensitivity analysis.
If standard deviations (SDs) are not specifically reported, we will attempt to determine these from standard errors, confidence intervals or exact P values, if available.
Assessment of heterogeneity
We will assess statistical heterogeneity by visual inspection of the confidence intervals on the forest plots and use of the Chi² test (P value < 0.1 will be interpreted as significant heterogeneity) and the I² statistic. When using I², our interpretation will be based on advice from Higgins 2011: i.e. up to 40% might not be important, 30% to 60% may represent moderate heterogeneity, 50% to 90% may represent substantial heterogeneity and 75% to 100% may represent very substantial ('considerable') heterogeneity.
Assessment of reporting biases
Where sufficient numbers of studies (more than 10) are available for meta‐analysis, we will construct a funnel plot to identify potential for publication bias.
Data synthesis
When considered appropriate, we will pool results of comparable groups of trials using both fixed‐effect and random‐effects models. The 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%, Deeks 2011) 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
We anticipate that interventions may be combined with reconstruction techniques, such as the use of bone graft substitutes, at either the donor or recipient site. If sufficient data exist, we will attempt a subgroup analysis of reconstruction with synthetic and autologous reconstruction versus solely autologous reconstruction.
We will also conduct separate subgroup analyses comparing the surgical approach (e.g. anterior versus posterior) and intended bone harvest type (e.g. cortical versus cancellous versus corticocancellous versus cancellous bone).
We will investigate whether the results of subgroups are significantly different by assessing the overlap of CIs and performing the relevant test for subgroup differences available in RevMan (RevMan 2014).
We will investigate the effects of removing studies with outlying results.
Sensitivity analysis
If sufficient trials are available, we will use sensitivity analyses to investigate aspects of trial methodology, including high or unclear risk of bias, such as selection bias arising from the lack of allocation concealment. In particular, we will perform a sensitivity analysis to investigate the impact of including any quasi‐randomised trials. Additionally, the effect of any other important decisions, such as the inclusion of trials only reported in conference abstracts and the selection of the statistical method for data synthesis, made during the conduct of the review will be tested. These sensitivity analyses will be restricted to primary outcomes in the first instance.
We will conduct two sensitivity analyses to explore the potential effects of missing data ‐ an extreme and moderate analysis. For the extreme analysis, missing binary outcomes will be treated as failures and missing continuous data as lying at the extreme of the distribution (2 SDs). For the moderate analysis, missing continuous data will be treated as lying at 1 SD from the mean. This approach will have little effect on studies with low proportions of loss to follow‐up but may highlight studies for which this is a concern.
'Summary of findings' tables and assessing the quality of evidence
Where there are sufficient data for the main comparisons, we will create 'Summary of findings' tables to summarise the results (Schünemann 2011). We will report on the three primary outcomes and the three secondary outcomes listed in Types of outcome measures. In the first instance, we will attempt to provide overall data for participants with persistent and serious donor site complications and participants with early complications. Where totals cannot be computed, we will use our judgement to select the most serious individual complications data for the table.
Irrespective of our decision to produce summary of findings tables, we will use the GRADE system to evaluate the quality of evidence (very low, low, moderate or high) for the six outcomes for all comparisons evaluated by the included trials.
Acknowledgements
We are grateful to Tim Briggs, Helen Handoll and Mario Lenza for valuable comments on the protocol. We would also like to thank Laura MacDonald for her guidance and Joanne Elliott for her help in refining our search strategy.
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
The Cochrane Library (Wiley Online Library)
#1 MeSH descriptor: [Bone Transplantation] explode all trees #2 MeSH descriptor: [Transplantation, Autologous] this term only #3 MeSH descriptor: [Autografts] explode all trees #4 MeSH descriptor: [Tissue and Organ Harvesting] explode all trees #5 (transplant* or graft* or harvest* or autograft or autotransplant* or autolog* or autogen*).tw #6 or/1‐6 #7 MeSH descriptor: [Ilium] this term only #8 MeSH descriptor: [Pelvic Bones] explode all trees #9 (iliac adj3 crest).tw #10 or/7‐9 #11 #6 and #10 #12 MeSH descriptor: [Fractures, Bone] explode all trees #13 MeSH descriptor: [Fracture Healing] this term only #14 fracture*.tw #15 or/12‐14 #16 #11 and #15
Ovid MEDLINE
1 Bone Transplantation/ 2 Transplantation, Autologous/ 3 Autografts/ 4 "Tissue and Organ Harvesting"/ 5 (transplant* or graft* or harvest* or autograft or autotransplant* or autolog* or autogen*).tw. 6 tr.fs. 7 or/1‐6 8 Ilium/su, tr [Surgery, Transplantation] 9 Pelvic Bones/su, tr [Surgery, Transplantation] 10 (iliac adj3 crest).tw. 11 or/8‐10 12 7 and 11 13 exp Fractures, Bone/ 14 Fracture Healing/ 15 fractur*.tw. 16 or/13‐15 17 12 and 16 18 Randomized controlled trial.pt. 19 Controlled clinical trial.pt. 20 randomized.ab. 21 placebo.ab. 22 Drug therapy.fs. 23 randomly.ab. 24 trial.ab. 25 groups.ab. 26 or/18‐25 27 exp Animals/ not Humans/ 28 26 not 27 29 17 and 28
Ovid Embase
1 exp Bone Transplantation/ 2 Autotransplantation/ 3 Autograft/ 4 (transplant* or graft* or harvest* or autograft or autotransplant* or autolog* or autogen*).tw. 5 tr.fs. 6 or/1‐5 7 Iliac Crest/ 8 Iliac Bone/ 9 Pelvic Girdle/ 10 (iliac adj3 crest).tw. 11 or/7‐10 12 6 and 11 13 exp Fracture/ 14 exp Fracture Healing/ 15 Fracture Treatment/ 16 fractur*.tw. 17 or/13‐16 18 12 and 17 19 Randomized controlled trial/ 20 Clinical trial/ 21 Controlled clinical trial/ 22 Randomization/ 23 Single blind procedure/ 24 Double blind procedure/ 25 Crossover procedure/ 26 Placebo/ 27 Prospective study/ 28 ((clinical or controlled or comparative or placebo or prospective* or randomi#ed) adj3 (trial or study)).tw. 29 (random* adj7 (allocat* or allot* or assign* or basis* or divid* or order*)).tw. 30 ((singl* or doubl* or trebl* or tripl*) adj7 (blind* or mask*)).tw. 31 (cross?over* or (cross adj1 over*)).tw. 32 ((allocat* or allot* or assign* or divid*) adj3 (condition* or experiment* or intervention* or treatment* or therap* or control* or group*)).tw. 33 RCT.tw. 34 or/19‐33 35 Case Study/ or Abstract Report/ or Letter/ 36 34 not 35 37 18 and 36
Bone & Joint Journal Orthopaedic Proceedings
Advanced search
1. Abstract or title: iliac crest (words ‐ all) Full text or abstract or title: random* Limit from 2006 to present Narrow search by Orthopaedic Proceedings
2. Title: transplant* graft* harvest* autograft autotransplant* autolog* autogen* (words ‐ any) Abstract or title: fracture Full text or abstract or title: random* Limit from 2006 to present Narrow search by Orthopaedic Proceedings
WHO International Clinical Trials Registry Platform Search Portal
Basic search
iliac AND transplant* OR iliac AND graft* OR iliac AND harvest* OR iliac AND autograft OR iliac AND autotransplant* OR iliac AND autolog* OR iliac AND autogen*
Advanced search 1. Title field: bone graft* and fracture Recruitment status: All
2. Title field: transplant* or graft* or harvest* or autograft or autotransplant* or autolog* or autogen* Condition: fracture Recruitment status: All
3. Title field: iliac crest Condition: fracture Recruitment status: All
ClinicalTrials.gov
Basic search
1. fracture AND (transplant OR graft OR harvest OR autograft OR autotransplant OR autolog OR autogen)
2. iliac crest AND (transplant OR graft OR harvest OR autograft OR autotransplant OR autolog OR autogen)
Advanced search
1. Search terms: transplant OR graft OR harvest OR autograft OR autotransplant OR autolog OR autogen Conditions: fracture
2. Search terms: iliac crest Conditions: fracture
What's new
| Date | Event | Description |
|---|---|---|
| 12 April 2018 | Amended | This out‐of‐date protocol was withdrawn in April 2018 due to a lack of progress on the review. |
Contributions of authors
Xavier L Griffin drafted the protocol and contributed to the search strategy. He is guarantor of the review. Benjamin T Robinson drafted the protocol and contributed to the search strategy. Andrew V Cuff drafted the protocol and contributed to the search strategy. David Metcalfe drafted the protocol and contributed to the search strategy. Katherine J Hewitt contributed to the protocol and the search strategy. Daniel J Rossiter contributed to the protocol. Victoria N Gibbs contributed to the protocol. Thomas E Pidgeon contributed to the protocol.
Declarations of interest
Xavier L Griffin: None known. Benjamin T Robinson: None known. Andrew V Cuff: None known. David Metcalfe: None known. Katherine J Hewitt: None known. Daniel J Rossiter: None known. Victoria N Gibbs: None known. Thomas E Pidgeon: None known.
Notes
This out‐of‐date protocol was withdrawn in April 2018 due to a lack of progress on the review.
Withdrawn from publication for reasons stated in the review
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