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Hip FracturesPhase 3EMvsIMNCT00597779

Randomized Comparison of 2 Fixation Techniques for Unstable Intertrochanteric Hip Fractures

A Phase 3 study testing Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN) in people with Hip Fractures, run by Rudy Reindl at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Hip Fractures
What is being tested?
Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteCanada
Study dates
Feb 2007to Nov 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 55 years or older
  • Type A2 Intertrochanteric fractures
  • Mono trauma
  • Medically fit for surgery
  • Less than 2 weeks post fracture

Who cannot join

  • Fractures due to malignancy
  • Non-ambulatory pre-fracture
  • Severe dementia
  • Limited life expectancy due to significant medical co-morbidities
  • Medical contraindication to surgery
  • Inability to comply with rehabilitation of form completion

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McGill University Health Centre - Montreal General Hospital

    Montreal, Quebec, H3G 1A4

Other trials in Canada

About this study

Official title: Extramedullary vs. Intramedullary Devices in the Treatment of Unstable Intertrochanteric Hip Fractures

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.

Read the 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.

Conditions
Hip Fractures
Being tested
Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)
Keywords
intertrochanteric fractures
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)Device

    Also called Extramedullary plate/ screw device , Intramedullary nail

    Surgical stabilization of unstable intertrochanteric hip fractures using two commonly used implant categories

Study groups in NCT00597779
Study groupRoleWhat they receive
EM deviceActive comparatorExtramedullary Device (EM)
Receives: Device: Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)
IM deviceActive comparatorIntramedullary Device (IM)
Receives: Device: Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Timed 2 minute walking distance

    Measured: 6 weeks, 3 months, 6 months and 12 months

  2. TUG (Time up and go) test

    Measured: 6 weeks, 3 months, 6 months and 12 months

  3. Trendelenburg's test: pelvic drop

    Measured: 6 weeks, 3 months, 6 months and 12 months

  4. Fracture classification: Mueller/ AO, displacement, time to union, heterotopic ossification and shortening.

    Measured: 6 weeks, 3 months, 6 months and 12 months

  5. FIM (Functional Independence Measure)

    Measured: 6weks, 3months, 6months and 12months

  6. LEM (Lower Extremity Measure)

    Measured: 6weeks, 3months, 6months and 12 months

Secondary outcomes (5)
  1. Secondary Outcome Variable: Transfusions

    Measured: 6 weeks, 3 months, 6 months and 12 months

  2. Pre and Post operative Hgb

    Measured: 6 weeks, 3 months, 6 months and 12 months

  3. Complications/ Re-operation

    Measured: 6 weeks, 3 months, 6 months and 12 months

  4. Length of surgery and hospital stay

    Measured: 6 weeks, 3 months, 6 months and 12 months

  5. Weight bearing status post-op

    Measured: 6 weeks, 3 months, 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2008 (estimated)
  2. Study startFeb 2007
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00597779
Sponsor's protocol ID
GEN #07-065
Acronym
EMvsIM
Status last verified
Aug 2014
First submitted
9 Jan 2008
Last updated
18 Aug 2014
Results posted
No
Data monitoring committee
No

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.

    PubMed 26631990

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN) in people with Hip Fractures, run by Rudy Reindl at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed 2 minute walking distance (time frame: 6 weeks, 3 months, 6 months and 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00597779, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014; AzTrials last refreshed its copy on 31 Oct 2026.

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