Non-inflammatory Degenerative Joint Disease
Conditions
Keywords
total hip replacement, primary cementless total hip arthroplasty, metal ion, metal-on-metal
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.
Interventions
PROCEDURETotal Hip Replacement
Sponsors
University of Western Ontario, Canada
DePuy Orthopaedics
Anderson Orthopaedic Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cobalt, chromium, and titanium ion levels in blood and urine | Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, United States
Outcome results
None listed