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Re-Evaluation of GAmma3 Intramedullary Nails in Hip Fracture (REGAIN)

This study is currently recruiting participants.
Verified by Hamilton Health Sciences, May 2008

Sponsors and Collaborators: Hamilton Health Sciences
Stryker Orthopaedics
Information provided by: Hamilton Health Sciences
ClinicalTrials.gov Identifier: NCT00555945
  Purpose

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. We will also compare functional recovery, complications, and quality of life.


Condition Intervention
Femoral Neck Fractures
Inter-Trochanteric Hip Fracture
Procedure: Gamma3 intramedullary nail (Stryker)
Procedure: Sliding Hip Screw

MedlinePlus related topics:   Fractures    Hip Injuries and Disorders    Hip Replacement   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
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

Further study details as provided by Hamilton Health Sciences:

Primary Outcome Measures:
  • Rates of revision surgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   90
Study Start Date:   May 2007
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   June 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Gamma3 intramedullary nail
Procedure: Gamma3 intramedullary nail (Stryker)
The Gamma3 nail is a short, interlocking intramedullary device. It consists of a sliding lag screw which passes through a short intramedullary nail. One of the two screws may be used to secure it to the femoral shaft.
2: Active Comparator
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.

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 1950s 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.

  Eligibility
Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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. We 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555945

Contacts
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    

Locations
Canada, Ontario
Henderson Hospital     Recruiting
      Hamilton, Ontario, Canada, L8N 1T8
      Contact: Justin de Beer, MD     905-527-1115     justin.debeer@ontariomd.ca    
      Contact: Liz Piccirillo, RN     905-527-4322 ext 42767     picceliz@hhsc.ca    
      Principal Investigator: Justin de Beer, MD            
St. Joseph's Hospital     Recruiting
      Hamilton, Ontario, Canada, L8N 4A6
      Contact: Leslie McKnight, BS     905-522-1155 ext 35877     mcknig@mcmaster.ca    
      Principal Investigator: Anthony Adili, MD            
Hamilton General Hospital     Recruiting
      Hamilton, Ontario, Canada, L8L 2X2
      Contact: Helena Viveiros, BSc BA     905-527-4322 ext 44696     viveiro@mcmaster.ca    
      Contact: Julia Pemberton, BSc.     905-512-6086     pemberj@mcmaster.ca    
      Principal Investigator: Bradley Petrisor, MD, FRCSC            
St. Michael's Hospital     Recruiting
      Toronto, Ontario, Canada, M5C 1R6
      Contact: Milena (Lynn) Vicente, RN     416-360-4000 ext 2608     vicentem@smh.toronto.on.ca    
      Principal Investigator: Emil Schemitsch, MD, FRCSC            
Denmark
Aarhus University Hospital     Recruiting
      Aarhus, Denmark
      Contact: Marianne Peick     011 45 8 949-4540     mpchr@as.aaa.dk    
      Principal Investigator: Ole Brink, Prof.            
      Sub-Investigator: Lars Borris, MD            
      Sub-Investigator: Kjeld Hougaard, MD            
      Sub-Investigator: Svend E Heiselberg, MD            
Sweden
Sahlgrenska University Hopsital     Recruiting
      Gothenburg, Sweden
      Contact: Mari Jonsson, RN     011 46 31 3428248     mari.jonsson@vgregion.se    
      Principal Investigator: Carl Ekholm, Prof.            
      Sub-Investigator: Hans Granhed, Prof.            
      Sub-Investigator: Alicja Bojan, MD            
      Sub-Investigator: Simon Vikstrom, MD            

Sponsors and Collaborators
Hamilton Health Sciences
Stryker Orthopaedics

Investigators
Principal Investigator:     Mohit Bhandari, MD FRCSC MSc     Hamilton Health Sciences    
  More Information

International Hip Fracture Research Collaborative  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Stryker Orthopaedics ( Anders Joensson )
Study ID Numbers:   RE-001
First Received:   November 7, 2007
Last Updated:   May 23, 2008
ClinicalTrials.gov Identifier:   NCT00555945
Health Authority:   Canada: Ethics Review Committee

Keywords provided by Hamilton Health Sciences:
femoral neck fractures  
inter-trochanteric hip fracture  
Gamma3 intramedullary nail  
sliding hip screw  
hip fracture  

Study placed in the following topic categories:
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

Additional relevant MeSH terms:
Hip Injuries

ClinicalTrials.gov processed this record on August 29, 2008




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