Re-Evaluation of GAmma3 Intramedullary Nails in Hip Fracture (REGAIN) (REGAIN)
|ClinicalTrials.gov Identifier: NCT00555945|
Recruitment Status : Completed
First Posted : November 9, 2007
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment|
|Femoral Neck Fractures Intertrochanteric Fracture||Procedure: Gamma3 intramedullary nail (Stryker) Procedure: Sliding Hip Screw|
Hip fractures are becoming a more prevalent issue worldwide, leading to profound morbidity, and in some cases, mortality. Currently the most common method of surgical treatment includes the use of a sliding hip screw over a Gamma intramedullary nail, but there is conflicting evidence regarding which device has a lower revision of surgery rate and complication rate. The newest generation of Gamma3 nails have strong rationale suggesting significantly decreased rates of femoral shaft fractures and improved function. The improvements in implant design of the Gamma3 nail provide compelling rationale for the conduct of a large, definitive trial, and therefore a pilot study is being conducted to confirm or refute our ability to recruit patients and assess the consistency between site estimates and actual recruitment, determine the degree to which site investigators can adhere to trial protocol, confirm or refute our anticipated ability to achieve close to 100% follow- up, assess our ability to maintain 100% data quality, field test our case report forms for clarity and appropriateness, and to determine whether we can successfully manage the logistics of coordinating trial activities across multiple sites.
This trial is a pilot, multi-center, concealed randomized controlled trial. Surgeons will use one of the two surgical strategies in patients who have sustained a trochanteric fracture; the Gamma3 intramedullary nail or the sliding hip screw. Clinical assessments will occur at the time of hospital admission, 1 week, 3 months, 6 months, and 12 months after surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||May 2007|
|Primary Completion Date :||June 2009|
|Study Completion Date :||June 2009|
Active Comparator: 1
Gamma3 intramedullary nail
Procedure: Gamma3 intramedullary nail (Stryker)
The Gamma3 nail is cannulated for Guide-Wire-controlled insertion, and features a conical tip for optimal alignment with the inner part of the cortical bone. A single distal Locking Screw is provided to stabilize the nail in the medullary canal and to help to prevent rotation in complex fractures.
Active Comparator: 2
Sliding hip screw
Procedure: Sliding Hip Screw
The sliding hip screw is a single larger diameter partially threaded screw, which is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixation.
- Rates of revision surgery [ Time Frame: 1 year ]Revision surgery is classified as any unplanned surgery done to promote fracture healing, relieve pain, treat infection, or improve function include the following: 1) implant removal prior to fracture healing (to achieve union); 2) revision surgery with another internal fixation implant; 3) revision surgery to arthroplasty; 4) incision and drainage for deep infection at the bone implant interface; 5) correction of malunion; and 6) repair of a femoral shaft fracture.
- Health Related Quality of Life [ Time Frame: Up to12 months ]HRQL will be measured using using self-administered and interview-administered questionnaires. Functional outcome questionnaires will include a generic health status measurement instrument (SF-12v2), a hip function and pain questionnaire (WOMAC), a generic utility measure (EQ-5D), the Merle d'Aubigne (MDA) pain and function score, and the Parker mobility score.
- Fracture healing rates [ Time Frame: Up to12 months ]A fracture is to be considered healed when there is obliteration of the fracture lines by newly formed bone along the cortices and within the trabecular bone on anteroposterior and lateral (or oblique) radiographs.
- Complications [ Time Frame: Up to12 months ]Complications include mortality, femoral shaft fracture, avascular necrosis, nonunion, malunion (shortening, varus deformity, valgus deformity and rotational malunion), implant breakage or failure, and infection (i.e., superficial and deep).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555945
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|St. Joseph's Hospital|
|Hamilton, Ontario, Canada, L8N4A6|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5C1R6|
|Aarhus University Hospital|
|Sahlgrenska University Hospital|
|Principal Investigator:||Mohit Bhandari, MD FRCSC MSc||McMaster University|