A Comparison of a Resurfacing Hip System to Standard Total Hip Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Wright Medical Technology
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00253877
First received: November 10, 2005
Last updated: August 19, 2010
Last verified: August 2010
  Purpose

This study compares outcomes and metal ion levels between patients who receive the Conserve® Plus Hip System compared to those who have received a standard hip replacement in a recent study.


Condition Intervention Phase
Osteoarthritis
Device: Hip Resurfacing System
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Centre, Historical Control Trial Comparing the Conserve® Plus Resurfacing Hip System to Standard Total Hip Arthroplasty.

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Rate of complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Any complications pertaining specifically to the implant


Secondary Outcome Measures:
  • Survivorship rate Clinical efficacy (Pain, Function, Radiographic outcome and Patient Satisfaction) Blood and Urine Ion Levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Clincial efficiency pertaining to the implant directly


Enrollment: 200
Study Start Date: July 2003
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conserve Plus Hip Resurfacing
Conserve Plus Hip Resurfacing
Device: Hip Resurfacing System
All patients received the Conserve Plus Hip Resurfacing System, manufactured by Wright Medical Technology
Other Name: non applicable

Detailed Description:

Total hip arthroplasty (THA) is currently the standard of care for end-stage degenerative joint disease of the hip. In this surgery, the entire joint is replaced by inserting an acetabular component into the pelvis, a femoral stem down the thigh bone (which has a ball on it to articulate in the acetabulum). However for the younger patient, long-term fixation and the prospect of multiple revisions remain a notable concern. Long-term results of THA in this patient population have been disappointing. Studies cite failure rates of 21% to 33% at less than 10 years follow up. The Conserve Plus Hip System differs from total hip arthroplasty as it uses less bone stock from the femoral bone. The prosthesis is designed so that the head of the femoral bone is resurfaced rather than replaced. Consequently, bone stock of the femur is conserved. The bone conserving nature of this implant allows the surgeon to convert to a total hip arthroplasty with ease should a time arise when the patient requires revision arthroplasty. The Conserve Plus Hip System is also different from the THA as the bearing surface is metal on metal, rather than the conventional metal on polyethylene. This metal on metal bearing surface provides lower wear. Theoretically, this type of hip replacement may be a viable alternative to THA for the younger patient.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients who are undergoing primary hip surgery for noninflammatory degenerative joint disease (NIDJD). Composite diagnoses for NIDJD include osteo/degenerative arthritis, traumatic arthritis, congenital hip dysplasia, and avascular necrosis.2. Patients who are skeletally mature or at least 18 years of age.3. Patients for whom there is a reasonable expectation that they will be available for each examination scheduled over a two year post-operative follow up period and for annual exams until the last patient entered into the study has achieved two years of follow-up.4. Patients who agree to participate and sign the informed consent form.5. Patients who do not meet any of the exclusion criteria.6. Patients who are already enrolled in the study and present with a need for revision of the metal femoral or acetabular resurfacing components. These patients may have the failed component(s) revised with an investigational component.

Exclusion Criteria:

  • . Patients who are less than 18 years of age or are skeletally immature at the time of surgery.2. Patients who present with inflammatory degenerative joint disease or revision surgery other than that specified in the inclusion criteria.3. Patients with previous fusions, acute femoral neck fractures and above knee amputations.4. Patients with evidence of active infection.5. Patients who are pregnant (or plan on becoming pregnant) or who are lactating.6. Patients with neurologic or musculoskeletal disease that may adversely affect gait or weight bearing.7. Patients who have previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar, or total hip replacement device.8. Patients with active hepatitis or HIV infection.9. Patients who otherwise meet the study criteria, but refuse to consent in writing to participate in the study. 10. Patients who are obese where obesity is defined as a Body Mass Index (BMI) >35.11. Patients with neuropathic joints.12. Patients with severe documented psychiatric disease.13. Patients requiring structural bone grafts.14. Patients with a documented allergy to cobalt chromium molybdenum.15. Patients with ipsilateral girdlestone.16. Patients with sickle cell disease.17. Patients with significant femoral head or neck deformity or significant acetabular wall deficiency.18. Patients with renal impairment where renal impairment is defined as serum creatinine> 180umol/L.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253877

Locations
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
Ottawa Hospital Research Institute
Wright Medical Technology
Investigators
Principal Investigator: Paul Kim, MD, FRCS(C) OHRI
  More Information

No publications provided

Responsible Party: Dr. Paul Kim, Ottawa Hospital, General Campus
ClinicalTrials.gov Identifier: NCT00253877     History of Changes
Other Study ID Numbers: OHREB 2003137-01H
Study First Received: November 10, 2005
Last Updated: August 19, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
osteoarthritis
hip resurfacing

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

ClinicalTrials.gov processed this record on April 23, 2014