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

Primary Purpose

Femoral Neck Fractures, Intertrochanteric Fracture

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Gamma3 intramedullary nail (Stryker)

Sliding Hip Screw

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Intertrochanteric fracture, Gamma3 intramedullary nail, Sliding hip screw

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult men or women aged 50 years and older (with no upper age limit).
An trochanteric 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 optimization of the patient for operative fixation of the proximal femur.
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.

Sites / Locations

Hamilton General Hospital
St. Joseph's Hospital
St. Michael's Hospital
Aarhus University Hospital
Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Gamma3 intramedullary nail

Sliding hip screw

Outcomes

Primary Outcome Measures

Rates of revision surgery

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.

Secondary Outcome Measures

Health Related Quality of Life

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

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

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).

Full Information

NCT ID

NCT00555945

First Posted

November 7, 2007

Last Updated

June 24, 2011

Sponsor

Stryker Trauma GmbH

Collaborators

Stryker Osteosynthesis, Global Research Solutions

1. Study Identification

Unique Protocol Identification Number

NCT00555945

Brief Title

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

Acronym

REGAIN

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 Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Stryker Trauma GmbH

Collaborators

Stryker Osteosynthesis, Global Research Solutions

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on rate of revision surgery in individuals with inter-trochanteric fractures. Secondary outcomes include fracture healing rates, fracture related complications, and health-related quality of life.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Femoral Neck Fractures, Intertrochanteric Fracture

Keywords

Intertrochanteric fracture, Gamma3 intramedullary nail, Sliding hip screw

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Gamma3 intramedullary nail

Arm Title

Arm Type

Active Comparator

Arm Description

Sliding hip screw

Intervention Type

Procedure

Intervention Name(s)

Gamma3 intramedullary nail (Stryker)

Other Intervention Name(s)

Gamma Nail, Gamma3 Nail, Intramedullary Nail (IM Nail)

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Sliding Hip Screw

Other Intervention Name(s)

Sliding Hip Screw (SHS), Dynamic Hip Screw (DHS), Compression Screw and Side Plate

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rates of revision surgery

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Health Related Quality of Life

Description

Time Frame

Up to12 months

Title

Fracture healing rates

Description

Time Frame

Up to12 months

Title

Complications

Description

Time Frame

Up to12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult men or women aged 50 years and older (with no upper age limit). An trochanteric 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 optimization of the patient for operative fixation of the proximal femur. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohit Bhandari, MD FRCSC MSc

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

St. Joseph's Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N4A6

Country

Canada

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5C1R6

Country

Canada

Facility Name

Aarhus University Hospital

City

Aarhus

Country

Denmark

Facility Name

Sahlgrenska University Hospital

City

Gothenburg

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

8832319

Citation

Parker MJ, Pryor GA. Gamma versus DHS nailing for extracapsular femoral fractures. Meta-analysis of ten randomised trials. Int Orthop. 1996;20(3):163-8. doi: 10.1007/s002640050055.

Results Reference

background

PubMed Identifier

12151898

Citation

Ahrengart L, Tornkvist H, Fornander P, Thorngren KG, Pasanen L, Wahlstrom P, Honkonen S, Lindgren U. A randomized study of the compression hip screw and Gamma nail in 426 fractures. Clin Orthop Relat Res. 2002 Aug;(401):209-22. doi: 10.1097/00003086-200208000-00024.

Results Reference

background

PubMed Identifier

11879828

Citation

Harrington P, Nihal A, Singhania AK, Howell FR. Intramedullary hip screw versus sliding hip screw for unstable intertrochanteric femoral fractures in the elderly. Injury. 2002 Jan;33(1):23-8. doi: 10.1016/s0020-1383(01)00106-1.

Results Reference

background

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

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