Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00253877
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Wright Medical Technology
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE November 10, 2005
First Posted Date  ICMJE November 15, 2005
Last Update Posted Date September 10, 2018
Actual Study Start Date  ICMJE July 2003
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2010)
Rate of complications [ Time Frame: 2 years ]
Any complications pertaining specifically to the implant
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2005)
Rate of complications
Change History Complete list of historical versions of study NCT00253877 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2010)
Survivorship rate Clinical efficacy (Pain, Function, Radiographic outcome and Patient Satisfaction) Blood and Urine Ion Levels [ Time Frame: 2 years ]
Clincial efficiency pertaining to the implant directly
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2005)
Survivorship rate Clinical efficacy (Pain, Function, Radiographic outcome and Patient Satisfaction) Blood and Urine Ion Levels
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of a Resurfacing Hip System to Standard Total Hip Arthroplasty
Official Title  ICMJE A Prospective, Multi-Centre, Historical Control Trial Comparing the Conserve® Plus Resurfacing Hip System to Standard Total Hip Arthroplasty.
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Other: Complication rate
All patients in the active comparator group received the Conserve Plus Hip Resurfacing System, manufactured by Wright Medical Technology. The complication rate and clinical efficacy will be recorded and compared to the Total Hip Replacement historical control group.
Study Arms
  • Active Comparator: Conserve Plus Hip Resurfacing
    Conserve Plus Hip Resurfacing group. Complication rate will be compared between groups.
    Intervention: Other: Complication rate
  • Total Hip Replacement
    Historical Total Hip Replacement control group of recently published conventional total hip replacement results (Williams, 2002). Complication rate will be compared between groups.
    Intervention: Other: Complication rate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2005)
200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00253877
Other Study ID Numbers  ICMJE OHREB 2003137-01H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE Wright Medical Technology
Investigators  ICMJE
Principal Investigator: Paul Kim, MD, FRCS(C) OHRI
PRS Account Ottawa Hospital Research Institute
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP