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Cochrane Database Syst Rev. 2018; 2018(2): CD010524.
Published online 2018 Feb 2. doi:10.1002/14651858.CD010524.pub2
PMCID: PMC6491114
Ran Xiong, Qi‐Guang Mai, Cheng‐Liang Yang, Shu‐Xi Ye, Xiao Zhang, and Shi‐Cai Fan
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This article is an update of with doi:10.1002/14651858.CD010524.
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effects (benefits and harms) of different methods of intramedullary nailing for femoral shaft fractures in adults.
Background
Description of the condition
The femur or thigh bone is the largest bone of the body. The femoral shaft or diaphysis is the long straight middle section of the femur. Femoral shaft fractures are usually the result of high‐energy trauma, such as road traffic accidents.The annual incidence of femoral shaft fractures is approximately 10 per 100,000 people (Weiss 2009).The ratio of males and females who suffered femoral shaft fractures was reported to be 174:100 in Salminen 2000. Salminen 2000 found that males have a peak age‐related incidence of femoral shaft fracture between the ages of 15 and 24 years, and females have a peak incidence of these fractures at 85 years and above.
Femoral shaft fractures may be closed, where the overlying tissues are intact, or open, where the bone is exposed placing the person at great risk of wound infection and contamination. These fractures are generally classified according to the morphological character of fracture line. Common descriptors are transverse (short and horizontal), oblique (straight but not horizontal), spiral (shape of a coil) and comminuted (more than three fragments). The AO/OTA system is an advanced and complex classification scheme which is commonly used. Based on the fracture pattern and location, femoral shaft fractures are coded as 32 and divided into three categories (A, B, C) and ultimately 27 different patterns according to the AO/OTA system (Marsh 2007).
Femoral shaft fractures are sometimes associated with polytrauma (multiple injuries in three or more parts of the body), which can be life‐threatening. These fractures can result in severe and permanent disability, such as from limb shortening and rotational deformity of the leg. Other common complications of these fractures include infection, residual pain, delayed union and nonunion.
Description of the intervention
Most femoral shaft fractures are treated surgically. Several studies have indicated that early surgical stabilisation is associated with a reduction of complications and mortality (Fakhry 1994). An intramedullary nail is a metal rod that is inserted intothe medullary cavityof a bone and across the fracture in order to provide a solid support for the fractured bone. Intramedullary nailing is currently considered the "gold standard" for treatment of femoral shaft fractures (Rudloff 2009). Proposed advantages of intramedullary nailing include short hospital‐stay, rapid union of the fracture and early functional use of the limb (Winquist 1984).
There are numerous different types of intramedullary nail and associated surgical techniques in use. One key controversy is whether the nail should be inserted into the canal at the knee and pushed up the canal (retrograde nailing) or at the hip and pushed down the canal (antegrade nailing). The entry point for antegrade nailing (piriformis fossa versus greater trochanteric entry) is also in dispute. Another issue is whether intramedullary nails should be inserted with reaming (where the medullary cavity is expanded before nail insertion) or without reaming. Likewise, there has been no agreement about the effects of different types of nails, such as interlocking nails (with locking bolts placed across the bone at the ends of the nail to secure it in position) or Ender nails, where two or more nails are placed within the medullary cavity in a specific way to hold them in place.
How the intervention might work
Intramedullary nailing aims to preserve the anatomical structure of fracture sites and to provide a proper environment for fracture healing. This in turn should improve function and reduce long‐term complications such as pain from arthritis. Furthermore, nailing helps to limit the damage to the soft tissues in the vicinity of bone during surgery and thereby helps preserve the blood supply to allow fracture healing and obtain a good functional recovery.
The reported advantages of antegrade nailing of the femur include a high rate of union and a low risk of malunion. However, due to its entry point and route, antegrade nailing is associated with a high risk of hip complications, such as heterotopic ossification about the hip, injury of the pudendal nerve and residual pain (Ricci 2001). Retrograde nailing is often applied for more complex cases such as the treatment of ipsilateral femoral shaft and femoral neck fractures, ipsilateral femoral shaft and pelvic or acetabular fractures, polytrauma and pregnant women (Sanders 1993). There is some evidence suggesting that retrograde nail insertion is easier, with less blood loss and without the expected increase in knee‐related pain and complications (Moed 1998).
The classic approach of inserting a straight nail through the greater trochanter has been reported to be prone to severe heterotopic ossification, fracture comminution and varus deformity. The management of femoral shaft fractures with nails implanted through the piriformis fossa may reduce the risk of these complications and be quicker to perform (Stannard 2011).
Postulated advantages for reamed nailing include improved fit within the medullary cavity and thus a stronger fixation for the fractured bone, and accelerated healing resulting from the bone debris created during reaming. Hypothetically, unreamed nailing should be quicker and easier to do with less disruption to the blood supply, which should help healing and reduce the risk of infection.
Easier insertion, combined with minimal damage to the endosteum, makes Ender nailing an attractive choice for treating femoral shaft fractures. However, although Ender nails could produce micromovement that may facilitate callus formation at the fracture sites, they are unlikely to provide a strong preservation of length, alignment and rotation. Indeed, Ender nailing may increase the frequency of delayed union and malunion. Although a more complex operation, securing the ends of the nails in the bone as in interlocking nails should provide absolute stability for unstable fractures (Eriksson 1979; Yamaji 2002).
Why it is important to do this review
Femoral shaft fractures are serious injuries that generally result in short‐term disability and pain but also have a high risk of longer‐term deformity and disability. However, these complications are not inevitable and may be reduced by a good treatment programme. There are several types of intramedullary nails and associated techniques available for the management of femoral shaft fractures. To make an informed decision, it is important to systematically review the available evidence to find the best methods of intramedullary nailing for optimising outcome.
Objectives
To assess the effects (benefits and harms) of different methods of intramedullary nailing for femoral 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 hospital number) controlled clinical trials evaluating intramedullary nailing for femoral shaft fractures in adults.
Types of participants
We will include adults (> 16 years old) undergoing primary surgery of open or closed femoral shaft fractures. We will exclude trials that focus primarily on the treatment of children with these fractures or adults with periprosthetic or pathological fractures.
Types of interventions
We will make comparisons of different categories and methods of intramedullary nailing. The comparisons will include:
Insertion portal/approach (e.g. retrograde versus antegrade, piriformis fossa versus greater trochanteric entry nailing);
Nailing technique (e.g. reamed versus unreamed; locked versus unlocked);
Type of nail (e.g. interlocking nail versus Ender nail; titanium versus steel nail).
Trials making comparisons other than those above will also be included.
Types of outcome measures
Primary outcomes
Patient‐rated functional outcome measures (e.g. AKSS (American Knee Society Score) (Insall 1989), the Lower‐Limb Tasks Questionnaire (McNair 2007); and Lysholm score (Lysholm 1982));
Health‐related quality of life measures (HRQOL, e.g. Short‐form 36 (Ware 1992));
Re‐operations for complications and/or treatment failure.
Secondary outcomes
Nonunion or delayed union;
Malunion, limp, rotational deformity;
Long‐term or persistent pain;
Any peri‐operative or post‐operative medical complication (as detailed in each individual study);
Operative details (e.g. operating time and blood loss);
Knee range of motion and other objective measures of functional impairment;
Mortality.
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 (The Cochrane Library; Wiley Online Library), MEDLINE (Ovid Online; 1946 to present) and EMBASE (Ovid Online; 1980 to present). We will also search Current Controlled Trials and the WHO International Clinical Trials Registry Platform for ongoing and recently completed trials. There will be no restrictions based on language or publication status.
In MEDLINE, we will combine subject‐specific terms with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials (sensitivity‐ and precision‐maximizing version) (Lefebvre 2011). Details of search strategies for The Cochrane Library, MEDLINE and EMBASE are shown in Appendix 1.
Searching other resources
Unpublished or grey literature will be reviewed using Open Grey (System for Information on Grey Literature in Europe). Proceedings of important meetings such as the Orthopaedic Trauma Association will be searched. We will check the reference lists of published studies to identify additional trials. Where necessary, authors of identified studies will be contacted.
Data collection and analysis
Selection of studies
Two review authors (RX and QGM) will independently screen the electronic search results. After obtaining full articles of potentially eligible studies, the same authors will independently perform study selection. Where there are disagreements after discussion, a third review author (FSC) will act as arbitrator.
Data extraction and management
Two review authors (RX and QGM) will independently extract data using a piloted data extraction form. The data collected will include those on setting; patient numbers, gender, age, type of fracture at baseline; details of the surgical procedure and post‐operative therapy; the follow‐up schedule and participant flow; types of outcome measures and trial results. Any disagreement will be resolved by discussion, or with the assistance of a third review author (FSC) where necessary.
Assessment of risk of bias in included studies
Two review authors will independently assess the risk of bias in included studies using The Cochrane Collaboration's 'Risk of bias' tool (Chapter 8.5, Higgins 2011). The following domains will be evaluated:
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessment (detection bias)
Incomplete outcome data (attrition bias)
Selective reporting (reporting bias)
Other potential sources of bias (e.g. major baseline imbalance; differences in operating surgeons' experience with the interventions under test; differences between intervention in post‐operative care such as the timing of weight bearing.
Where necessary, disagreements will be resolved by discussion. A third review author (FSC) will be asked to act as arbitrator if necessary.
Measures of treatment effect
Risk ratios (RRs) and 95% confidence intervals (CIs) will be presented for dichotomous outcomes, and mean differences and 95% CIs will be calculated for continuous outcomes. We will use standardised mean differences and 95% CIs when pooling continuous data from outcomes measured in different ways or scales (e.g. functional outcomes).
Unit of analysis issues
We anticipate that the unit of randomisation in the included studies will usually be the individual patient. However, where trials included adults with bilateral fractures, results may be presented for fractures or limbs rather than individual patients. Where such unit of analysis issues arise and appropriate corrections have not been made, we will consider presenting the data for such trials only where the disparity between the units of analysis and randomisation is small. We will avoid unit of analysis issues relating to repeated observations of the same outcome, such as results presented for several periods of follow‐up.
Dealing with missing data
Where data are missing or unsuitable for analysis, we will contact trial authors to obtain further information and data if possible. Where appropriate, we will perform an intention‐to‐treat analysis in which all randomised patients are analysed in the groups to which they were primarily assigned. If participant dropout leads to missing data for dichotomous outcomes, we will conduct a sensitivity analysis where participants with missing data will be viewed as treatment failures and included in the analysis. Unless we can calculate missing standard deviations from standard errors, 95% confidence intervals or exact P values, we will not impute these.
Assessment of heterogeneity
We will assess the clinical heterogeneity of trials testing the same comparison. Statistical heterogeneity will be assessed by visual inspection of the forest plots and the I² statistic. Our interpretation of the I² results will follow that suggested in Higgins 2011: 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% may represent considerable heterogeneity.
Assessment of reporting biases
If sufficient trials (more than 10) provide data for a meta‐analysis, we will attempt to assess publication bias by generating a funnel plot.
Data synthesis
When considered appropriate, results of comparable groups of trials will be pooled using both fixed‐effect and random‐effects models. The choice of the model to report will be guided by a 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 studies that are included. Ninety‐five per cent confidence intervals will be used 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 the trials. Where it is not appropriate to pool data, we will still present trial data in the analyses or tables for illustrative purposes and report these in the text.
Subgroup analysis and investigation of heterogeneity
Where data allow, the following subgroup analyses will be performed:
Fracture types (the AO classification system categories: A, B and C);
Open versus closed fractures;
Age (people < 60 versus people > 60).
We will investigate whether the results of subgroups are significantly different by inspecting the overlap of confidence intervals and performing the test for subgroup differences available in RevMan.
Sensitivity analysis
If sufficient trials are available, we will perform sensitivity analyses to examine various aspects of trial and review methodology, including the effects of missing data, the selection of statistical model (fixed‐effect versus random‐effects) for pooling, the effects of excluding trials at high or unclear risk of bias, such as selection bias arising from the lack of allocation concealment, and trials only reported in conference abstracts.
'Summary of findings' tables
Where there is sufficient evidence, we will prepare 'Summary of findings' tables. We shall use the GRADE approach to assess the quality of evidence related to the primary and first four secondary outcomes listed in theTypes of outcome measures(Chapter 12.2,Higgins 2011).
Acknowledgements
We are grateful for helpful comments on drafts of the protocol from Helen Handoll and Marc Swiontkowski. We would also like to thank Lindsey Elstub for her assistance and Joanne Elliott for developing the search strategies.
Appendices
Appendix 1. Search strategies
The Cochrane Library (Wiley Online Library)
#1 MeSH descriptor: [Femoral Fractures] this term only #2 MeSH descriptor: [Fracture Fixation] explode all trees #3 MeSH descriptor: [Fractures, Bone] this term only #4 #2 or #3 #5 MeSH descriptor: [Femur] this term only #6 #4 and #5 #7 "femur":ti (Word variations have been searched) #8 femoral:ti (Word variations have been searched) #9 #7 or #8 #10 fracture*:ti,ab,kw (Word variations have been searched) #11 #9 and #10 #12 #1 or #6 or #11 #13 [mh ^"Internal Fixators"] or [mh ^"Bone Screws"] or [mh "Fracture Fixation, Internal"] or [mh ^"Bone Nails"] #14 pin* or nail* or screw* or fix* or prosthes* or ream* or unreamed or piriformis fossa or trochanter* or ender or interlocking or lock*:ti,ab,kw (Word variations have been searched) #15 #13 or #14 #16 #12 and #15 #17 SR‐MUSKINJ #18 #16 not #17
MEDLINE (Ovid Online)
1 Femoral Fractures/ 2 exp Fracture Fixation/ 3 Fractures, Bone/ 4 2 or 3 5 Femur/ 6 4 and 5 7 Femur.ti. 8 femoral.ti. 9 7 or 8 10fracture*.tw. 119 and 10 121 or 6 or 11 13Internal Fixators/ or Bone Screws/ or exp Fracture Fixation, Internal/ or Bone Nails/ 14(pin* or nail* or screw* or fix* or prosthes* or ream* or unreamed or piriformis fossa or trochanter* or ender or interlocking or lock*).tw. 1513 or 14 1612 and 15 17Randomized controlled trial.pt. 18Controlled clinical trial.pt. 19randomized.ab. 20placebo.ab. 21 Clinical Trials as Topic/ 22randomly.ab. 23 trial.ti. 2417 or 18 or 19 or 20 or 21 or 22 or 23 25exp Animals/ not Humans/ 2624 not 25 2716 and 26
EMBASE (Ovid Online)
1 Femur Fracture/ or Femur Shaft Fracture/ 2 Fracture/ or Fracture Healing/ 3 Fracture fFxation/ 4 2 or 3 5 Femur/ or Femur Shaft/ 6 4 and 5 7 femur.ti. 8 femoral.ti. 9 7 or 8 10fracture*.tw. 119 and 10 121 or 6 or 11 13Intramedullary Nail/ or Internal Fixator/ or Bone Screw/ or Bone Nail/ 14(pin* or nail* or screw* or fix* or prosthes* or ream* or unreamed or piriformis fossa or trochanter* or ender or interlocking or lock*).tw. 1513 or 14 1612 and 15 17exp Randomized Controlled Trial/ or exp Single Blind Procedure/ or exp Double Blind Procedure/ 18(random* or placebo or allocat* or crossover* or 'cross over' or trial or (doubl* adj1 blind*) or (singl* adj1 blind*)).ti,ab. 19or/17‐18 20Animal/ or Animal Experiment/ or Nonhuman/ 21Human/ 22and/20‐21 2320 not 22 24 19 not 23 2516 and 24 26(hip*1 or ((proximal or neck or trochant* or subtrochant* or intertrochant*) adj2 (femur* or femoral))).ti. 27(shaft or diaphys*).tw. 2826 and 27 2926 not 28 3025 not 29
Notes
Withdrawn from publication for reasons stated in the review
What's new
| Date | Event | Description |
|---|---|---|
| 2 February 2018 | Amended | Protocol withdrawn from publication. |
Contributions of authors
Ran Xiong, Qi‐Guang Mai, Cheng‐Liang Yang, Shu‐Xi Ye, Xiao Zhang, Shi‐Cai Fan all contributed to the preparation of the protocol. Ran Xiong will be the guarantor of the review.
Sources of support
Internal sources
The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.
Library, Southern Medical University, Guangzhou, China.
External sources
No sources of support supplied
Declarations of interest
None known.
Notes
The published protocol has been withdrawn because it is substantially out‐of‐date and the authors are no longer able to complete the review.
References
Additional references
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