A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements

February 15, 2012 updated by: Nova Scotia Health Authority
The purpose of this study is to answer the question as to whether or not a fully coated cementless stem is equal to or better than a cemented stem in patients over 72 years with good bone quality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

72 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients undergoing surgery for total hip replacements, including diagnosis of osteoarthritis, rheumatoid arthritis, traumatic and post-traumatic arthritis, avascular necrosis and congenital dislocation of the hip. Congenital dislocation of the hip will be included where small but anatomical acetabuli are present, ie., the acetabuli located near the tear-drop
  • Revisions of failed osteotomies may be included
  • Bone quality felt to be acceptable to the surgeon for cementless arthroplasty preoperatively in patients > 72 years of age

Exclusion Criteria:

  • Patients with active infection
  • Revision cemented total hip replacement
  • Charcot joints
  • Patients with primary or secondary bone tumors in the vicinity of the joint to be replaced
  • C.D.H. with abnormally placed acetabuli or femoral canals
  • Fibromyalgia patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fully Coated Prodigy Stem (AML)
Total hip arthroplasty with fully coated prodigy stem (AML)
Device: Fully coated Prodigy stem
Total hip arthroplasty with fully coated Prodigy stem
Active Comparator: Cemented Endurance Hip Stem
Total hip arthroplasty with cemented Endurance hip stem component
Device: Cemented Endurance Stem
total hip arthroplasty with cemented endurance stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Revision

Secondary Outcome Measures

Outcome Measure
Womac
SF-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Ross K Leighton, MD, FRCS(C), Capital Health, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (Estimate)

June 4, 2008

Study Record Updates

Last Update Posted (Estimate)

February 16, 2012

Last Update Submitted That Met QC Criteria

February 15, 2012

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDHA-RL-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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