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

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ClinicalTrials.gov Identifier: NCT00689689
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : February 16, 2012
Sponsor:
Information provided by (Responsible Party):
Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Fully coated Prodigy stem Device: Cemented Endurance Stem Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements
Study Start Date : July 1998
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

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




Primary Outcome Measures :
  1. Revision

Secondary Outcome Measures :
  1. Womac
  2. SF-12


Information from the National Library of Medicine

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Ages Eligible for Study:   72 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689689


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

Responsible Party: Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT00689689     History of Changes
Other Study ID Numbers: CDHA-RL-005
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: February 16, 2012
Last Verified: May 2008

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