NCT00555945

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Typical duration for not_applicable

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

2.1 years

First QC Date

November 7, 2007

Last Update Submit

June 24, 2011

Conditions

Femoral Neck FracturesIntertrochanteric Fracture

Keywords

Intertrochanteric fractureGamma3 intramedullary nailSliding hip screw

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (3)

  • Health Related Quality of Life

    Up to12 months

  • Fracture healing rates

    Up to12 months

  • Complications

    Up to12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Gamma3 intramedullary nail

Procedure: Gamma3 intramedullary nail (Stryker)

2

ACTIVE COMPARATOR

Sliding hip screw

Procedure: Sliding Hip Screw

Interventions

Gamma3 intramedullary nail (Stryker)PROCEDURE

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.

Also known as: Gamma Nail, Gamma3 Nail, Intramedullary Nail (IM Nail)
1
Sliding Hip ScrewPROCEDURE

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.

Also known as: Sliding Hip Screw (SHS), Dynamic Hip Screw (DHS), Compression Screw and Side Plate
2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, L8N4A6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5C1R6, Canada

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 8832319BACKGROUND

  • 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.

    PMID: 12151898BACKGROUND

  • 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.

    PMID: 11879828BACKGROUND

MeSH Terms

Conditions

Femoral Neck FracturesHip Fractures

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation, InternalFracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Mohit Bhandari, MD FRCSC MSc

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 9, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

DK(1)SE(1)CA(3)