Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00689689
First received: May 30, 2008
Last updated: February 15, 2012
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Device: Fully coated Prodigy stem
Device: Cemented Endurance Stem
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Revision [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Womac [ Designated as safety issue: No ]
  • SF-12 [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: July 1998
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   72 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689689

Locations
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Ross K Leighton, MD, FRCS(C) Capital Health, Canada
  More Information

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00689689     History of Changes
Other Study ID Numbers: CDHA-RL-005
Study First Received: May 30, 2008
Last Updated: February 15, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014