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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 7, 2007 | ||||||||
| Last Updated Date | December 31, 2008 | ||||||||
| Start Date ICMJE | May 2007 | ||||||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Rates of revision surgery [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
The primary objective is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on rates of revision surgery at two years in individuals with inter-trochanteric fractures. [ Time Frame: 2 years ] | ||||||||
| Change History | Complete list of historical versions of study NCT00555945 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
To evaluate the impact of Gamma3 IM nails vs sliding hip screws on complications, fracture healing rates, and health related quality of life (HRQL). [ Time Frame: 2 years ] | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Re-Evaluation of GAmma3 Intramedullary Nails in Hip Fracture (REGAIN) | ||||||||
| Official Title ICMJE | Re-Evaluation of GAmma3 Intramedullary Nails in Hip Fracture: A Multi-Centre Randomized Controlled Trial of Gamma3 Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip | ||||||||
| Brief Summary | The purpose of this study is to investigate whether Gamma3 intramedullary nails versus sliding hip screws will decrease the rate of revision surgeries at two years in patients with inter-trochanteric fractures of the hip. The investigators will also compare functional recovery, complications, and quality of life. |
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| Detailed Description | Hip Fractures are anatomically classified in relation to the hip capsule as intracapsular fractures (i.e., femoral neck) or extracapsular fractures (i.e., intertrochanteric and subtrochanteric). Approximately 50 percent of hip fractures compromise intertrochanteric fractures (extracapsular fractures). These extracapsular fractures occur in a line between the greater and lesser trochanters, generally in elderly patients and women secondary to osteoporosis. This trial will focus on management options for inter-trochanteric fractures of the hip. Intertrochanteric fractures may be either stable (a single fracture line without displacement) or unstable (multiple fracture lines (comminution) with displacement). Patients who present with an intertrochanteric fracture may experience hip pain, decreased function and quality of life. The extremity appears shortened and significantly externally rotated. Operative treatment of extracapsular hip fractures was introduced in the 1950's using a variety of different implants. Orthopaedic surgeons agree that internal fixation is the standard for the management of intertrochanteric fractures. Implants may be either intramedullary or extramedullary. Two common devices include the Gamma nail (intramedullary) and the sliding hip screw (extramedullary). Both approaches have strong physiologic rationale and ardent advocates. Complications of internal fixation of the intertrochanteric fracture include implant failures, infections, femoral shaft fractures, malunion, and nonunion of the bone. Over 20 percent of patients with an intertrochanteric fracture repaired with internal fixation experience a complication. These complications usually require a revision surgery and are associated with high morbidity and appreciable mortality. Even patients who do not require revision surgery may have long-term functional limitation and diminished quality of life due to soft tissue damage at the time of surgery. In summary, while sliding hip screws have the advantage of reduced need for revision surgery (primarily the result of decreased risk of femoral shaft fracture) in most intertrochanteric fractures of the hip, the newer generation Gamma3 Nails (Gamma3) have strong rationale and early supportive data suggesting significantly decreased rates of femoral shaft fractures and improved function. The improvements in implant design provide compelling rationale for the conduct of a large, definitive trial. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 90 | ||||||||
| Estimated Completion Date | June 2009 | ||||||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada, Denmark, Sweden | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00555945 | ||||||||
| Responsible Party | Anders Joensson, Stryker Orthopaedics | ||||||||
| Study ID Numbers ICMJE | RE-001 | ||||||||
| Study Sponsor ICMJE | Hamilton Health Sciences | ||||||||
| Collaborators ICMJE | Stryker Orthopaedics | ||||||||
| Investigators ICMJE |
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| Information Provided By | McMaster University | ||||||||
| Verification Date | December 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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