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Randomized Comparison of 2 Fixation Techniques for Unstable Intertrochanteric Hip Fractures (EMvsIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00597779
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : August 18, 2014
Sponsor:
Collaborator:
Orthopaedic Trauma Association
Information provided by (Responsible Party):
Rudy Reindl, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE January 9, 2008
First Posted Date  ICMJE January 18, 2008
Last Update Posted Date August 18, 2014
Study Start Date  ICMJE February 2007
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2009)
  • Timed 2 minute walking distance [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • TUG (Time up and go) test [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • Trendelenburg's test: pelvic drop [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • Fracture classification: Mueller/ AO, displacement, time to union, heterotopic ossification and shortening. [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • FIM (Functional Independence Measure) [ Time Frame: 6weks, 3months, 6months and 12months ]
  • LEM (Lower Extremity Measure) [ Time Frame: 6weeks, 3months, 6months and 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2008)
  • LEM (Lower extremity measure) [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • SF-36 [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • Timed 20m walk distance [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • TUG (Time up and go) test [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • Trendelenburg's test: pelvic drop [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • Fracture classification: Mueller/ AO, displacement, time to union, heterotopic ossification and shortening. [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2008)
  • Secondary Outcome Variable: Transfusions [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • Pre and Post operative Hgb [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • Complications/ Re-operation [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • Length of surgery and hospital stay [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
  • Weight bearing status post-op [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Comparison of 2 Fixation Techniques for Unstable Intertrochanteric Hip Fractures
Official Title  ICMJE Extramedullary vs. Intramedullary Devices in the Treatment of Unstable Intertrochanteric Hip Fractures
Brief Summary

The purpose of this study is to compare the clinical and radiological outcome of patients that are treated with two different orthopedic implants. The study population will consist of patients that have sustained unstable hip fractures. The two different implants will be randomly assigned.

The null hypothesis states that there should not be any significant differences between the two implants.

Detailed Description

Intertrochanteric hip fractures are common injuries in the elderly population. They often signify generalized physical deterioration. Operative management has become the standard of care to prevent life threatening complications and dates back to the 1940's. The design of implants has evolved significantly since then.

The sliding hip screw replaced static fixation of the femoral head in the 1950's. As a result of this improvement in design, failures have been reduced to 9-16%. The sliding hip screw allows for stable collapse of the femoral neck. This can lead to significant shortening of the proximal femur in comminuted fractures.

Current treatment modalities focus on obtaining a satisfactory union of the fracture, often at the expense of anatomical alignment. Severely comminuted fractures treated with a standard plate-hip-screw device thus commonly result in significant degrees of mal-union and shortening. In the past, implants designed to restore and maintain the anatomy of the hip have resulted in high failure rates with the implant breaking out of the femoral head. In the mid 1980's, recognition of this led to the development of various intramedullary devices for fixation of these fractures. The weight-bearing portion of the implant is therefore shifted medially, resulting in reduced lever forces on the implant and femur. Additionally, the IM device does not rely on fixation to the lateral cortex of the femur with screws. From a biomechanical standpoint, the intramedullary device has distinct advantages, as it is a load- sharing device more closely located to the axis of weight bearing than the plate-hip-screw device.

Advances in intramedullary designs have been promising, but the clinical results variable. The relatively high rate of fracture at the tip, specifically at the level of the locking bolts, has hampered the widespread popularity of intramedullary devices. Additionally, the large diameter of the proximal aspect of the implants required extensive reaming of the greater trochanter and partial detachment of the gluteus medius. This may lead to abductor weakness and a Trendelenburg gait. Some studies have found increased re-operation rates for these early hip-nail devices compared to the plate -hip-screw implant. Other studies have shown decreased blood loss and operative time with the nails. A meta-analysis of the literature favors the sliding hip screw design. Unfortunately, most studies focus on radiological failure rate rather than patient function and relate to the first generation of IM devices.

The newest generation of nails (like the IM studied here) has attempted to correct the shortcomings of earlier designs. The proximal aspect of the nail diameter is minimized. The distal locking screw is located far away from the distal end of the nail and the locking bolt is placed in an oblique fashion. Design alterations to the femoral head fixation portion of the nail by using a helical blade rather than a screw may improve fixation in the femoral head. These new designs seem to compare favorably in recent clinical tests. Early mobilization for patients with the intramedullary device (IM) seems to be better.

Results of the pilot study indicate an earlier return to full mobility and shorter operating time in the IM group. This study included all intertrochanteric fracture types and did not demonstrate a clear benefit of the IM in many other parameters. The currently proposed multi-centre study will focus on the unstable A2 intertrochanteric fracture pattern.

Considering the significantly increased cost of the new intramedullary devices compared to the standard plate-hip-screw, a significant overall improvement in patient function should be realized before the general use of these new devices could be recommended.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hip Fractures
Intervention  ICMJE Device: Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)
Surgical stabilization of unstable intertrochanteric hip fractures using two commonly used implant categories
Other Name: Extramedullary plate/ screw device , Intramedullary nail
Study Arms  ICMJE
  • Active Comparator: EM device
    Extramedullary Device (EM)
    Intervention: Device: Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)
  • Active Comparator: IM device
    Intramedullary Device (IM)
    Intervention: Device: Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)
Publications * Reindl R, Harvey EJ, Berry GK, Rahme E; Canadian Orthopaedic Trauma Society (COTS). Intramedullary Versus Extramedullary Fixation for Unstable Intertrochanteric Fractures: A Prospective Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Dec 2;97(23):1905-12. doi: 10.2106/JBJS.N.01007.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2008)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 55 years or older
  2. Type A2 Intertrochanteric fractures
  3. Mono trauma
  4. Medically fit for surgery
  5. Less than 2 weeks post fracture

Exclusion Criteria:

  1. Fractures due to malignancy
  2. Non-ambulatory pre-fracture
  3. Severe dementia
  4. Limited life expectancy due to significant medical co-morbidities
  5. Medical contraindication to surgery
  6. Inability to comply with rehabilitation of form completion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00597779
Other Study ID Numbers  ICMJE GEN #07-065
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rudy Reindl, McGill University Health Centre/Research Institute of the McGill University Health Centre
Original Responsible Party Rudy Reindl MD FRCSC, McGill University Health Centre
Current Study Sponsor  ICMJE Rudy Reindl
Original Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE Orthopaedic Trauma Association
Investigators  ICMJE
Principal Investigator: Rudy Reindl, MD FRCSC McGill University Health Centre/Research Institute of the McGill University Health Centre
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP