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Re-Evaluation of GAmma3 Intramedullary Nails in Hip Fracture (REGAIN)
This study is currently recruiting participants.
Study NCT00555945   Information provided by McMaster University
First Received: November 7, 2007   Last Updated: December 31, 2008   History of Changes

November 7, 2007
December 31, 2008
May 2007
June 2009   (final data collection date for primary outcome measure)
Rates of revision surgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00555945 on ClinicalTrials.gov Archive Site
  • HRQL (SF-12,WOMAC,EQ-5D, Merle d'Aubigne (MDA), Parker Mobility score) [ Time Frame: hospital admission, 1 and 2 weeks, 3, 6, 9,12, 18 and 24 months ] [ Designated as safety issue: Yes ]
  • Fracture healing rates [ Time Frame: 3, 6, 9,12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Complications (mortality, femoral shaft fracture, avn, nonunion, malunion, implant breakage/failure, infection) [ Time Frame: ospital admission, 1 and 2 weeks, 3, 6, 9,12, 18 and 24 months ] [ Designated as safety issue: Yes ]
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 ]
 
Re-Evaluation of GAmma3 Intramedullary Nails in Hip Fracture (REGAIN)
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

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.

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.

 
Interventional
Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
  • Femoral Neck Fractures
  • Inter-Trochanteric Hip Fracture
  • Procedure: Gamma3 intramedullary nail (Stryker)
  • Procedure: Sliding Hip Screw
  • Active Comparator: Gamma3 intramedullary nail
  • Active Comparator: Sliding hip screw
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
90
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult men or women aged 50 years and older (with no upper age limit).
  • An intertrochanteric fracture (stable or unstable) confirmed with anterior and posterior lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
  • Operative treatment within 3 days (i.e., 72 hours) after the trauma.
  • Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
  • Anticipated medical optimalization of the patient for operative fixation of the hip.
  • Provision of informed consent by patient or proxy.
  • Low energy fracture (defined as a fall from standing height).
  • No other major trauma.

Exclusion Criteria:

  • Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
  • Retained hardware around the affected hip.
  • Infection around the hip (i.e., soft tissue or bone).
  • Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease,renal osteodystrophy, or osteomalacia).
  • Moderate or severe cognitively impaired patients (i.e., Six Item Screener with three or more errors).
  • Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
  • Likely problems, in the judgment of the investigators, with maintaining follow-up. The investigators will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
  • If the attending surgeon believes that a patient should be excluded from REGAIN because the patient is enrolled in another ongoing drug or surgical intervention trial.
  • If the attending surgeon believes that there is another reason to exclude this patient from REGAIN. This reason will be documented on the case report forms.
Both
50 Years and older
No
Contact: Helena Viveiros, BSc. BA 905-527-4322 ext 44696 viveiro@mcmaster.ca
Contact: Sheila Sprague, MSc. 905-527-4322 ext 44490 spags@mcmaster.ca
Canada,   Denmark,   Sweden
 
NCT00555945
Anders Joensson, Stryker Orthopaedics
RE-001
Hamilton Health Sciences
Stryker Orthopaedics
Principal Investigator: Mohit Bhandari, MD FRCSC MSc McMaster University
McMaster University
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP