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

Sponsor:	Hamilton Health Sciences
Collaborator:	Stryker Orthopaedics
Information provided by:	McMaster University
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. The investigators 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

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

Resource links provided by NLM:

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement Surgery

U.S. FDA Resources

Further study details as provided by McMaster University:

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 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.

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. 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.

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

McMaster University

More Information

Additional Information:

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

No publications provided

Responsible Party:	Stryker Orthopaedics ( Anders Joensson )
Study ID Numbers:	RE-001
Study First Received:	November 7, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00555945 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

femoral neck fractures
inter-trochanteric hip fracture
gamma3 intramedullary nail
sliding hip screw
hip fracture

Additional relevant MeSH terms:

Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone

Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Hip Injuries

ClinicalTrials.gov processed this record on November 25, 2009