Non-inflammatory Joint Diseases Clinical Trial
Official title:
Comparative Study to Evaluate the Safety and Efficacy of the DePuy Ceramic-on-metal Total Hip Prosthesis Versus the DePuy Metal-on-metal Total Hip Prosthesis Through Clinical and Radiographical Data
| Verified date | August 2013 |
| Source | DePuy Orthopaedics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components. The success of the total hip arthroplasty (THA) will be based upon all of the following clinical and radiographic criteria being met at the two-year evaluation: (1) the patient's clinical results as measured using modified Harris Hip evaluation rating system, and the absence of a complication that requires the surgical removal or replacement of a component; and (2) radiographic findings at study endpoint (i.e., two years follow-up). Clinical and radiographic success at two (2) years postoperative is required for the study hip to be deemed successful.
| Status | Completed |
| Enrollment | 392 |
| Est. completion date | June 2011 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Able to (or capable of) provide consent to participate in the clinical investigation prior to the day of the surgery. - Skeletally mature (tibial and femoral epiphyses are closed) - Undergoing cementless primary hip replacement surgery for Noninflammatory Degenerative Joint Disease - Affected hip has a Harris Hip Score of 70 or lower and a Pain rating of Moderate or greater - Radiographic Parameters: - X-Ray Evaluation confirms the presence of NIDJD - Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants - No structural bone grafts required to support to prosthetic component(s)or to shape the bone to receive implant(s) - Willing to have knowledge of treatment arm (CoM or MoM) withheld for a period of 24 months post-operatively unless disclosure is legally and/or medically necessary - Previous THA in contralateral hip that is greater than one (1) year postoperative and has a Harris Hip pain rating less than MILD Exclusion Criteria: - Bilateral hip disease with the anticipated need for bilateral hip implant during study participation (i.e., within the next 24 months) - THA required for the revision of a previously failed THA - Suffering from inflammatory arthritis - Prior prosthetic hip replacement - Previous Girdlestone procedure or surgical fusion in the operative hip joint - Above knee amputation of either the contralateral or ipsilateral leg - Known allergy to metal (e.g. jewelry) - The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.) - Significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis) - Conditions that may interfere with the total hip arthroplasty survival or outcome (e.g., Paget's disease, Charcot's disease) - Unwilling or unable to comply with a rehabilitation program for a cementless THA or difficulty or inability to return for follow-up visits prescribed by the study protocol - Known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser - Previous treatment for renal disease - Any systemic steroid therapy, excluding inhalers, within three months prior to surgery |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Anderson Clinic | Alexandria | Virginia |
| United States | Foundation for Musculoskeletal Research and Education | Little Rock | Arkansas |
| Lead Sponsor | Collaborator |
|---|---|
| DePuy Orthopaedics |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Composite Success/Failure | The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/< 2mm, acetabular migration =/< 2mm, cup inclination =/< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place. | At 24 months | Yes |