Back to resultsA Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Fully coated Prodigy stem
Cemented Endurance Stem
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- QEII Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fully Coated Prodigy Stem (AML)
Cemented Endurance Hip Stem
Arm Description
Total hip arthroplasty with fully coated prodigy stem (AML)
Total hip arthroplasty with cemented Endurance hip stem component
Outcomes
Primary Outcome Measures
Revision
Secondary Outcome Measures
Womac
SF-12
Full Information
NCT ID
NCT00689689
First Posted
May 30, 2008
Last Updated
February 15, 2012
Sponsor
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT00689689
Brief Title
A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements
Official Title
A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fully Coated Prodigy Stem (AML)
Arm Type
Active Comparator
Arm Description
Total hip arthroplasty with fully coated prodigy stem (AML)
Arm Title
Cemented Endurance Hip Stem
Arm Type
Active Comparator
Arm Description
Total hip arthroplasty with cemented Endurance hip stem component
Intervention Type
Device
Intervention Name(s)
Fully coated Prodigy stem
Intervention Description
Total hip arthroplasty with fully coated Prodigy stem
Intervention Type
Device
Intervention Name(s)
Cemented Endurance Stem
Intervention Description
total hip arthroplasty with cemented endurance stem
Primary Outcome Measure Information:
Title
Revision
Secondary Outcome Measure Information:
Title
Womac
Title
SF-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross K Leighton, MD, FRCS(C)
Organizational Affiliation
Capital Health, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements
We'll reach out to this number within 24 hrs