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.
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
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 group | Role | What they receive |
|---|---|---|
| EM device | Active comparator | Extramedullary Device (EM) Receives: Device: Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN) |
| IM device | Active comparator | Intramedullary 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.
Timed 2 minute walking distance
Measured: 6 weeks, 3 months, 6 months and 12 months
TUG (Time up and go) test
Measured: 6 weeks, 3 months, 6 months and 12 months
Trendelenburg's test: pelvic drop
Measured: 6 weeks, 3 months, 6 months and 12 months
Fracture classification: Mueller/ AO, displacement, time to union, heterotopic ossification and shortening.
Measured: 6 weeks, 3 months, 6 months and 12 months
FIM (Functional Independence Measure)
Measured: 6weks, 3months, 6months and 12months
LEM (Lower Extremity Measure)
Measured: 6weeks, 3months, 6months and 12 months
Secondary outcomes (5)
Secondary Outcome Variable: Transfusions
Measured: 6 weeks, 3 months, 6 months and 12 months
Pre and Post operative Hgb
Measured: 6 weeks, 3 months, 6 months and 12 months
Complications/ Re-operation
Measured: 6 weeks, 3 months, 6 months and 12 months
Length of surgery and hospital stay
Measured: 6 weeks, 3 months, 6 months and 12 months
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.
- First posted18 Jan 2008 (estimated)
- Study startFeb 2007
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rudy Reindl
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Responsible party
- Sponsor-investigator, Rudy Reindl, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Rudy Reindl, MD FRCSC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extramedullary vs. Intramedullary Devices in the Treatment of Unstable Intertrochanteric Hip Fractures
- ClinicalTrials.gov ID
- NCT00597779
- Acronym / sponsor ID
- EMvsIM / GEN #07-065
- Conditions
- Hip Fractures
- Keywords
- intertrochanteric fractures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rudy ReindlUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Study start
- Feb 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EM device | Active comparator | Device: Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)Extramedullary Device (EM) |
| IM device | Active comparator | Device: Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)Intramedullary Device (IM) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 55 years or older
- Type A2 Intertrochanteric fractures
- Mono trauma
- Medically fit for surgery
- Less than 2 weeks post fracture
Key exclusion criteria (6 listed)
- Fractures due to malignancy
- Non-ambulatory pre-fracture
- Severe dementia
- Limited life expectancy due to significant medical co-morbidities
- Medical contraindication to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Hip Screw (DHS); Trochanteric Fixation Nail (TFN)Also: Extramedullary plate/ screw device , Intramedullary nailSurgical stabilization of unstable intertrochanteric hip fractures using two commonly used implant categories | Device | EM device, IM device |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
- Derived from this study: PubMed 26631990Reindl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudy Reindl, MD FRCSC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
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.