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

This study has been completed.
Sponsor:
Collaborator:
Orthopaedic Trauma Association
Information provided by (Responsible Party):
Rudy Reindl, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00597779
First received: January 9, 2008
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Hip Fractures
Device: Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extramedullary vs. Intramedullary Devices in the Treatment of Unstable Intertrochanteric Hip Fractures

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Timed 2 minute walking distance [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • TUG (Time up and go) test [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Trendelenburg's test: pelvic drop [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Fracture classification: Mueller/ AO, displacement, time to union, heterotopic ossification and shortening. [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • FIM (Functional Independence Measure) [ Time Frame: 6weks, 3months, 6months and 12months ] [ Designated as safety issue: No ]
  • LEM (Lower Extremity Measure) [ Time Frame: 6weeks, 3months, 6months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Outcome Variable: Transfusions [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Pre and Post operative Hgb [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Complications/ Re-operation [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Length of surgery and hospital stay [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Weight bearing status post-op [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: February 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EM device
Extramedullary Device (EM)
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
Active Comparator: IM device
Intramedullary Device (IM)
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

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597779

Locations
Canada, Quebec
McGill University Health Centre - Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Rudy Reindl
Orthopaedic Trauma Association
Investigators
Principal Investigator: Rudy Reindl, MD FRCSC McGill University Health Center
  More Information

No publications provided

Responsible Party: Rudy Reindl, MD FRCSC, McGill University Health Center
ClinicalTrials.gov Identifier: NCT00597779     History of Changes
Other Study ID Numbers: GEN #07-065
Study First Received: January 9, 2008
Last Updated: August 14, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
intertrochanteric fractures

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on October 19, 2014