Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant
Not Applicable
Completed
- Conditions
- Non-inflammatory Degenerative Joint Disease
- Interventions
- Procedure: Total Hip Replacement
- Registration Number
- NCT00962351
- Lead Sponsor
- Anderson Orthopaedic Research Institute
- Brief Summary
This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Undergoing cementless primary total hip replacement
- Receiving acetabular cup of 52mm or greater
- Preoperative level of function and pain same as for conventional hip replacement
- Likelihood of obtaining relief of pain and improved function
- Full skeletal maturity
- Ability to follow instructions
- Good general health
- Willing to return for follow-up evaluations
- X-ray evaluation confirming the presence of NIDJD
- Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants
Exclusion Criteria
- Age less than 40 years or greater than 80 years at time of surgery
- Patients templated to receive an acetabular component smaller than 52mm in diameter
- Presence of a previous prosthetic hip replacement device in the hip joint to be operated
- Previous girdlestone procedure or surgical fusion of the hip to be operated
- Acute femoral neck fracture
- Above knee amputation of the contralateral and/or ipsilateral leg
- Patients with a diagnosis of inflammatory degenerative arthritis
- Skeletally immature
- Evidence of active infections that may spread to other areas of the body
- The presence of a highly communicable disease that may limit follow-up
- Presence of known active metastatic or neoplastic disease
- Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing
- Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome
- Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up
- Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
- Any patient who qualifies for inclusion in the study but refuses consent to participate in the study
- Any steroid therapy, local or systemic, within three months prior to surgery
- Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants
- Patient has known allergies to metal, e.g., jewelry
- Any patient not meeting all radiographic and clinical parameters for inclusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metal-on-Metal, 28mm femoral head Total Hip Replacement - Metal-on-Metal, 36mm femoral head Total Hip Replacement - Metal-on-Polyethylene Total Hip Replacement -
- Primary Outcome Measures
Name Time Method cobalt, chromium, and titanium ion levels in blood and urine Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years
- Secondary Outcome Measures
Name Time Method Hip function Pre-op, 6 months,1 year, 2 years, 3 years, 5 years Durability 6 months, 1 year, 2 years, 3 years, 5 years
Trial Locations
- Locations (2)
Anderson Orthopaedic Research Institute
🇺🇸Alexandria, Virginia, United States
Department of Orthopaedic Surgery, University of Western Ontario
🇨🇦London, Ontario, Canada