This is the current release of the guideline.

Diaphyseal femur fracture

To improve the treatment of diaphyseal fractures in pediatric patients based on the current best evidence

Children who have not yet reached skeletal maturity (toddler, school age, and teenage) with isolated diaphyseal fractures

Note: This guideline is not intended for use in pediatric patients who present with additional coexisting injuries that require formal surgical intervention or other life-threatening conditions that take precedence over the treatment of the diaphyseal femur fracture.

Evaluation and Treatment

1. Evaluation for child abuse
2. Use of Pavlik harness or spica cast (including waterproof cast liners) as age appropriate
3. Use of flexible intramedullary nailing as age appropriate
4. Use of rigid trochanteric entry nailing, submuscular plating, and flexible intramedullary nailing as age appropriate
5. Pain management

• Cost
• Mobility
• Complications (angulation, infection)
• Duration of treatment/return to school

Literature Searches

The search for eligible literature began with a search of the following databases on May 8, 2008 and updated on October 6, 2008:

• PubMed (from 1966 through October 1, 2008)
• EMBASE (from 1966 through October 1, 2008)
• CINAHL (from 1982 through October 1, 2008)
• The Cochrane Central Register of Controlled Trials (through October 1, 2008)

This initial search (after removal of duplicates) yielded 1181 articles, of which 274 were retrieved and evaluated. The full search strategies are listed below.

All literature searches were supplemented with manual screening of bibliographies in publications accepted for inclusion into the evidence base. In addition, the bibliographies of recent systematic reviews and other review articles were searched for potentially relevant citations.

General Search

PubMed was searched using the following strategy:

(diaphyseal OR diaphysis OR shaft OR diaphysial) AND fracture AND (femur OR femoral OR thigh) NOT "comment"[Publication Type] NOT "editorial"[Publication Type] NOT "letter"[Publication Type] NOT "Addresses"[Publication Type] NOT "News"[Publication Type] NOT "Newspaper Article"[Publication Type] AND (("1966/1/1"[EDat]:"2008/10/01"[EDat]) AND (Humans[Mesh]) AND (English[lang]) AND ((infant[MeSH] OR child[MeSH] OR adolescent[MeSH])) )

EMBASE was searched using the following strategy:

(diaphyseal OR ('diaphysis'/exp OR 'diaphysis') OR shaft OR diaphysial) AND ('fracture'/exp OR 'fracture') AND (('femur'/exp OR 'femur') OR femoral OR ('thigh'/exp OR 'thigh')) AND ([article]/lim OR [review]/lim) AND [english]/lim AND [humans]/lim AND ([infant]/lim OR [child]/lim OR [adolescent]/lim) AND [embase]/lim AND [1966-2008]/py

CINAHL was searched using the following strategy:

(diaphyseal OR diaphysis OR shaft OR diaphysial) AND fracture AND (femur OR femoral OR thigh)

Cochrane Central Register of Controlled Trials was searched using the following strategy:

(diaphyseal OR diaphysis OR shaft OR diaphysial) AND fracture AND (femur OR femoral OR thigh)

Waterproof Cast Liner Search

A search for literature pertaining to cast liners began with a search of the following databases on August 6, 2008 and updated on October 7, 2008:

PubMed was searched using the following strategy:

cast AND (liner OR waterproof)

EMBASE was searched using the following strategy:

cast AND (liner OR waterproof) AND [english]/lim AND [humans]/lim AND [embase]/lim

CINAHL was searched using the following strategy:

cast AND (liner OR waterproof)

Cochrane Central Register of Controlled Trials was searched using the following strategy:

cast AND (liner OR waterproof)

Study Selection Criteria

Types of Studies

A priori article selection criteria were developed for the review. Specifically, to be included in the systematic reviews an article had to be a report of a study that:

• Evaluated a treatment for isolated pediatric diaphyseal femur fracture
• Was a full article published in the peer reviewed literature
• Was an English language article published after 1965
• Was not a cadaveric, animal, or in vitro study
• Was not a retrospective case series, medical records review, meeting abstract, unpublished study report, case report, historical article, editorial, letter, or commentary
• Was the most recent report of a study or the report with the largest number of enrolled patients in a study with multiple publications
• Enrolled >10 patients in each of its study groups
• Enrolled a patient population of at least 80% of patients with a diaphyseal femur fracture and were not skeletally mature (closure of proximal and distal femoral growth plates)
• Reported quantified results
• Enrolled patients without the following conditions
  • Subtrochanteric fractures, supracondylar femur fractures, physeal fractures, open fractures, compound fractures, pathologic fractures, or multiple lower extremity fractures
  • Co-existing abdominal or neurological injuries requiring surgical intervention (the physician work group chair and co-chair determined whether an article met inclusion criteria in cases when studies reported insufficient detail to determine whether co-existing injuries required surgical intervention)
  • Osteogenesis imperfecta, cerebral palsy, myelodysplasia (spina bifida), metabolic bone diseases, or skeletal dysplasia

For the entire guideline, thirty-two primary studies were included

Levels of Evidence for Primary Research Question¹

1. A complete assessment of quality of individual studies requires critical appraisal of all aspects of the study design.
2. A combination of results from two or more prior studies.
3. Studies provided consistent results.
4. Study was started before the first patient enrolled.
5. Patients treated one way (e.g., cemented hip arthroplasty) compared with a group of patients treated in another way (e.g., uncemented hip arthroplasty) at the same institution.
6. The study was started after the first patient enrolled.
7. Patients identified for the study based on their outcome, called "cases" (e.g., failed total hip arthroplasty) are compared to those who did not have outcome, called "controls" (e.g., successful total hip arthroplasty).
8. Patients treated one way with no comparison group of patients treated in another way.

Judging the Quality of Evidence

The quality of evidence was rated using an evidence hierarchy and an accompanying checklist for randomized controlled trials (RCTs). This evidence hierarchy is shown in the "Rating Scheme for the Strength of the Evidence" field.

Randomized controlled trials were categorized as Level I studies, but the level of evidence was reduced by one level if there was a "No" or "Not Reported by Authors" to any of the following checklist questions:

• Was randomization stochastic? (i.e., at the time of assignment to groups, did all patients have an equal probability of being assigned to any given group?)
• Was there concealment of the allocation to groups?
• Were the patients, caregivers, or evaluators blinded?

Downgrading of Level I studies was not cumulative. If a study had more than one of the methodological flaws listed above, it would only decrease by a single level. The downgrading of the formal level of evidence of a study indicates the discrepancy between claims of the study authors and the results of the critical appraisal process.

Non-randomized controlled trials and other prospective comparative studies were categorized as Level II studies. Retrospective comparative studies and case-control studies were initially categorized as Level III studies and case-series studies/reports were categorized as Level IV studies.

When comparative studies had only one group that was relevant to the recommendation, the data from these studies were considered as Level IV evidence.

Data Extraction

Data elements extracted from studies were defined in consultation with the physician work group. Three reviewers completed data extraction independently for all studies. Disagreements were resolved by consensus and by consulting the work group. Evidence tables were constructed to summarize the best evidence pertaining to each preliminary recommendation. The elements extracted are shown in Appendix VI of the original guideline document.

This guideline and systematic review were prepared by the American Academy of Orthopaedic Surgeons (AAOS). Pediatric Diaphyseal Femur Fractures physician work group with the assistance of the AAOS Clinical Practice Guidelines Unit (see Appendix I of the original guideline document).

To develop this guideline, the work group initially met in an introductory meeting on April 5, 2008, to establish the scope of the guideline and systematic review. Upon completion of the systematic review the work group participated in a two-day recommendation meeting on November 8 and 9, 2008, at which the final recommendations were written and voted on.

Preliminary Recommendations

The work group began work on this guideline by constructing a set of preliminary recommendations. These recommendations specify [what] should be done in [whom], [when], [where], and [how often or how long]. They function as questions for the systematic review, not as final recommendations or conclusions. Simulated recommendations are almost always modified on the basis of the results of the systematic review. These recommendations also form the guideline's scope and guide the searches for literature. These a priori simulated recommendations are inviolate in that, once specified, they cannot be modified, they must all be addressed by the systematic review, and the relevant review results must be presented in the final guideline. The a priori and inviolate nature of the preliminary recommendations combats bias.

Grading the Recommendations

Following data extraction and analyses, each guideline recommendation was assigned a preliminary grade that was based on the total body of evidence available using the system illustrated in the "Rating Scheme for the Strength of the Recommendations" field.

Final grades were based upon preliminary grades assigned by AAOS staff, which took into account only the quality and quantity of the available evidence as listed in the table above. Work group members then modified the grade using the 'Form for Assigning Grade of Recommendation (Interventions)' shown in Appendix VII of the original guideline document. This form, which is based on recommendations of the GRADE Work Group, requires the work group to consider the harms, benefits, and critical outcomes associated with a treatment. It also requires the work group to evaluate the applicability of the evidence. The final grade is assigned by the physician work group, which modifies the preliminary grade on the basis of these considerations.

Consensus Development

The recommendations and their grades were voted on using a structured voting technique. Voting on guideline recommendations was conducted using a secret ballot. Each member of the guideline work group either agreed ("yes") or disagreed ("no") with a guideline recommendation. Work group members were blinded to the responses of other members. Unanimous agreement was needed in order for a recommendation to pass. If voting was not unanimous, there was further discussion to see whether the disagreement(s) could be resolved. Up to three rounds of voting were held to attempt to resolve disagreements. If disagreements were not resolved following three voting rounds, no recommendation was adopted.

Statistical Methods

Where applicable, odds ratios (OR) for dichotomous data and mean differences for continuous data were calculated.

When published studies only reported the median, range and size of the trial, their means and variances were estimated according to a published method. StatXact for the calculation of exact odds ratios confidence intervals for dichotomous data was used. All other calculations were performed using STATA 10.0 (StataCorp LP, College Station, Texas). The Wilson score method to calculate confidence intervals for proportions was used. For ordinal data, ordinal logistic regression was used to calculate odds ratios.

Grade of Recommendation

The guideline developers reviewed published cost analyses.

There are many components to consider when calculating the overall cost of treatment for pediatric femoral fracture. The main considerations for patients and third party payers are the relative cost and effectiveness of each treatment option. But hidden costs for pediatric patients must also be considered. These costs include the additional home care required for a patient, the costs of rehabilitation and of missed school for the patient, child care costs if both parents work, and time off of work required by one or both parents to care for the pediatric patient. 

Because the developers did not perform a formal cost analyses, costs were considered in the recommendations grading only if their impact was substantial.

Peer Review

The draft of the guideline and evidence report were peer reviewed by an expert outside advisory panel that was nominated by the physician work group prior to the development of the guideline (See Appendix VIII in the original guideline document). In addition, the physician members of the American Academy of Orthopaedic Surgeons (AAOS) Guidelines and Technology Oversight Committee and the Evidence Based Practice Committee provided peer review of the draft document. Peer review was accomplished using a structured peer review form. (See Appendix IX in the original guideline document) The authors forwarded the draft guideline to a total of thirty-three reviewers and eleven returned reviews. The disposition of all non-editorial peer review comments was documented and accompanied this guideline through the public commentary and the following approval process.

The following organizations participated in peer review of this clinical practice guideline:

• American Academy of Pediatrics, Section on Orthopaedics
• European Paediatric Orthopaedic Society
• Orthopaedic Trauma Association
• American Osteopathic Academy of Orthopedics
• American Academy of Orthopaedic Surgeons (AAOS) Committees
• Guidelines and Technology Oversight Committee (GTOC)
• Evidence Based Practice Committee (EBPC)

Public Commentary

After modifying the draft in response to peer review, the guideline was subjected to a thirty day period of "Public Commentary." Commentators consist of members of the AAOS Board of Directors (BOD), members of the Council on Research, Quality Assessment, and Technology (CORQAT), members of the Board of Councilors (BOC), and members of the Board of Specialty Societies (BOS). Based on these bodies, up to 185 commentators had the opportunity to provide input into the development of this guideline. Of these, 12 returned public comments.

The AAOS Guideline Approval Process

Following peer review, the final guideline draft was approved by the AAOS Guidelines and Technology Oversight Committee, the AAOS Evidence Based Practice Committee, the AAOS Council on Research, Quality Assessment, and Technology, and the AAOS Board of Directors. Descriptions of these bodies are provided in Appendix II in the original guideline document.

Definitions of the levels of evidence (I-V) and grades of recommendation (A-C, I) are provided at the end of the "Major Recommendations" field.

Note from the American Academy of Orthopaedic Surgeons (AAOS): This summary does not contain rationales that explain how and why these recommendations were developed nor does it contain the evidence supporting these recommendations. All readers of this summary are strongly urged to consult the full guideline and evidence report (see "Guideline Availability" and "Availability of Companion Documents" fields) for this information. The guideline developers are confident that those who read the full guideline and evidence report will also see that the recommendations were developed using systematic evidence-based processes designed to combat bias, enhance transparency, and promote reproducibility. This summary of recommendations is not intended to stand alone.

Recommendation 1

The authors recommend that children younger than thirty-six months with a diaphyseal femur fracture be evaluated for child abuse. (Grade A, Level II)

Recommendation 2

Treatment with a Pavlik harness or a spica cast are options for infants six months and younger with a diaphyseal femur fracture. (Grade C, Level IV)

Recommendation 3

The authors suggest early spica casting or traction with delayed spica casting for children age six months to five years with a diaphyseal femur fracture with less than 2 cm of shortening. (Grade B, Level II)

Recommendation 4

The authors are unable to recommend for or against early spica casting for children age six months to five years with a diaphyseal femur fracture with greater than 2 cm of shortening.  (Grade Inconclusive, Level V)

Recommendation 5

The authors are unable to recommend for or against patient weight as a criterion for the use of spica casting in children age six months to five years with a diaphyseal femur fracture. (Grade Inconclusive, Level V)

Recommendation 6

When using the spica cast in children six months to five years of age, altering the treatment plan is an option if the fracture shortens greater than 2 cm. (Grade C, Level V)

Recommendation 7

The authors are unable to recommend for or against using any specific degree of angulation or rotation as a criterion for altering the treatment plan when using the spica cast in children six months to five years of age. (Grade Inconclusive, Level V)

Recommendation 8

It is an option for physicians to use flexible intramedullary nailing to treat children age five to eleven years diagnosed with diaphyseal femur fractures. (Grade C, Level III)

Recommendation 9

Rigid trochanteric entry nailing, submuscular plating, and flexible intramedullary nailing are treatment options for children age eleven years to skeletal maturity diagnosed with diaphyseal femur fractures, but piriformis or near piriformis entry rigid nailing are not treatment options. (Grade C, Level IV)

Recommendation 10

The authors are unable to recommend for or against removal of surgical implants from asymptomatic patients after treatment of diaphyseal femur fractures. (Grade Inconclusive, Level IV)

Recommendation 11

The authors are unable to recommend for or against outpatient physical therapy to improve function after treatment pediatric diaphyseal femur fractures. (Grade Inconclusive, Level V)

Recommendation 12

Regional pain management is an option for patient comfort perioperatively. (Grade C, Level IV)

Recommendation 13

The authors are unable to recommend for or against the use of locked versus non-locked plates for fixation of pediatric femur fractures. (Grade Inconclusive, Level IV)

Recommendation 14

Waterproof cast liners for spica casts are an option for use in children diagnosed with pediatric diaphyseal femur fractures. (Grade C, Level III)

Definitions:

Levels of Evidence for Primary Research Question¹

1. A complete assessment of quality of individual studies requires critical appraisal of all aspects of the study design.
2. A combination of results from two or more prior studies.
3. Studies provided consistent results.
4. Study was started before the first patient enrolled.
5. Patients treated one way (e.g., cemented hip arthroplasty) compared with a group of patients treated in another way (e.g., uncemented hip arthroplasty) at the same institution.
6. The study was started after the first patient enrolled.
7. Patients identified for the study based on their outcome, called "cases" (e.g., failed total hip arthroplasty) are compared to those who did not have outcome, called "controls" (e.g., successful total hip arthroplasty).
8. Patients treated one way with no comparison group of patients treated in another way.

Grade of Recommendation Description

None provided

The type of supporting evidence is specifically stated for each recommendation (see the "Major Recommendations" field).

Appropriate treatment of diaphyseal femur fractures in pediatric patients

Potential risks and complications associated with surgery, including the risk of infection

This Clinical Practice Guideline was developed by an American Academy of Orthopaedic Surgeons (AAOS) physician volunteer Work Group based on a systematic review of the current scientific and clinical information and accepted approaches to treatment and/or diagnosis. This Clinical Practice Guideline is not intended to be a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician's independent medical judgment, given the individual patient's clinical circumstances.

An implementation strategy was not provided.

Not applicable: The guideline was not adapted from another source.

This guideline and evidence report were exclusively funded by the American Academy of Orthopaedic Surgeons who received no funding from outside commercial sources to support the development of this document.

American Academy of Orthopaedic Surgeons (AAOS) Treatment of Pediatric Diaphyseal Femur Fractures Workgroup

Workgroup Members: Mininder S. Kocher, MD, MPH (Chair), Children's Hospital, Orthopaedic Dept, Boston, MA; Ernest L. Sink, MD (Co-Chair), The Children's Hospital, Aurora, CO; R Dale Blasier, MD, Dept of Orthopaedic Surgery, Little Rock, AR; Scott J. Luhmann, MD, St Louis Children's Hospital, Saint Louis, MO; Charles T. Mehlman, DO, MPH, Children's Hospital Medical Center, Cincinnati, OH; David M. Scher, MD, Hospital for Special Surgery, New York, NY; Travis Matheney, MD, Children's Hospital Boston, Orthopedic Surgery, Boston, MA; James O Sanders, MD, Department of Orthopaedics, Rehabilitation University of Rochester, Rochester, NY

Guidelines Oversight Chair: William C. Watters III, MD, Houston, TX

Guidelines Oversight Vice-Chair: Michael J. Goldberg, MD, Children's Hospital and Regional Medical Center

Evidence Based Practice Committee Chair: Michael Warren Keith, MD, Cleveland, OH

American Academy of Orthopaedic Surgeons Staff: Robert H. Haralson III, MD, MBA, AAOS Medical Director; Charles M. Turkelson, PhD, Director of Research and Scientific Affairs; Janet L. Wies, MPH, Manager, Clinical Practice Guidelines; Patrick Sluka, MPH, Lead Research Analyst; Kristin Hitchcock, AAOS Medical Librarian

All members of the American Academy of Orthopaedic Surgeons (AAOS) work group disclosed their conflicts of interest prior to the development of the recommendations for this guideline. Conflicts of interest are disclosed in writing with the AAOS via a private on-line reporting database and also verbally at the recommendation approval meeting. Members of all AAOS Work Groups are required to disclose their conflicts of interest at the same level and depth of detail as the AAOS Board of Directors.

AAOS Disclosure Program Information

R Dale Blasier, MD (Little Rock, AR): 4 (Synthes); 7 (Synthes). Submitted on: 04/23/2008.

Michael J Goldberg, MD: 2 (Journal of Pediatric Orthopedics; Journal of Children's Orthopaedics). Submitted on: 12/11/2007.

Mininder S Kocher, MD (Boston, MA): 1 (Pediatric Orthopaedic Society of North America); 5A (Biomet; Regen Biologics; Smith & Nephew); 7 (CONMED Linvatec); 9 (Saunders/Mosby-Elsevier). Submitted on: 05/27/2008.

Scott J Luhmann, MD (Saint Louis, MO): 4 (Medtronic Sofamor Danek; Stryker); 5A (Medtronic Sofamor Danek); 7 (Medtronic Sofamor Danek). Submitted on: 08/05/2008.

Travis Matheney, MD (Boston, MA): (n). Submitted on: 10/29/2008

Charles T Mehlman, DO (Cincinnati, OH): 2 (Journal of Bone and Joint Surgery - American; Journal of Orthopaedics and Traumatology; Journal of Pediatric Orthopedics; Saunders/Mosby-Elsevier; Wolters Kluwer Health - Lippincott Williams & Wilkins; eMedicine (Orthopaedic Surgery); Journal Children's Orthopaedics (EPOS); The Orthopod (JAOAO); The Spine Journal (NASS)); 5B (Stryker); 7 (DePuy, A Johnson & Johnson Company; Medtronic Sofamor Danek; National Institutes of Health (NIAMS & NICHD); Synthes; University Cincinnati); 8 (Eli Lilly; Zimmer). Submitted on: 04/08/2008.

James O Sanders, MD (Rochester, NY): 7 (Medtronic Sofamor Danek; K2M); 8 (Abbott; Biomedical Enterprises). Submitted on: 07/30/2008.

David M Scher, MD (New York, NY): 1 (American Academy for Cerebral Palsy and Developmental Medicine; Pediatric Orthopaedic Club of New York); 2 (Hospital for Special Surgery Journal). Submitted on: 03/28/2008.

Ernest L Sink, MD (Aurora, CO): 1 (Pediatric Orthopaedic Society of North America); 2 (Orthopedics); 4 (Biomet); 5B (Biomet). Submitted on: 04/15/2008.

William Charles Watters III, MD: 1 (North American Spine Society; Work Loss Data Institute); 2 (The Spine Journal); 5A (Stryker; Intrinsic Therapeutics; MeKessen Health Care Solutions). Submitted on: 10/09/2007 at 08:09 PM and last confirmed as accurate on 04/23/2008.

Disclosure Items: (n) = Respondent answered 'No' to all items indicating no conflicts. 1=Board member/owner/officer/committee appointments; 2= Medical/Orthopaedic Publications; 3= Royalties; 4= Speakers bureau/paid presentations;5A= Paid consultant; 5B= Unpaid consultant; 6= Research or institutional support from a publisher; 7= Research or institutional support from a company or supplier; 8= Stock or Stock Options; 9= Other financial/material support from a publisher; 10= Other financial/material support from a company or supplier.

This is the current release of the guideline.

Electronic copies: Available in Portable Document Format (PDF) from the American Academy of Orthopaedic Surgeons Web site .

Print copies: Available from the American Academy of Orthopaedic Surgeons, 6300 North River Road, Rosemont, IL 60018-4262. Telephone: (800) 626-6726 (800 346-AAOS); Fax: (847) 823-8125; Web site: www.aaos.org .

The following is available:

• Treatment of pediatric diaphyseal femur fractures. Evidence tables. Rosemont (IL): American Academy of Orthopaedic Surgeons; 2009. 71 p. Electronic copies: Available in Portable Document Format (PDF) from the American Academy of Orthopaedic Surgeons Web site .

Print copies: Available from the American Academy of Orthopaedic Surgeons, 6300 North River Road, Rosemont, IL 60018-4262. Telephone: (800) 626-6726 (800 346-AAOS); Fax: (847) 823-8125; Web site: www.aaos.org .

None available

This NGC summary was completed by ECRI Institute on December 10, 2009. The information was verified by the developer on January 19, 2010.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. For more information, please contact AAOS Department of Research and Scientific Affairs, 6300 North River Road, Rosemont, IL 60018; Phone: (847) 823-7186; Fax: (847) 823-8125.