A Prospective Clinical Study On A Total Hip Resurfacing System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthritis
- Sponsor
- Zimmer Biomet
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
Detailed Description
The study is designed as a prospective, multi-center, non-randomized study. It is designed to evaluate the effects of metal-on-metal acetabular articulating bearing surfaces. The device will be used in conjunction with a cemented metal femoral resurfacing prosthesis. The objective of this clinical investigation is to evaluate the safety and effectiveness of the metal-on-metal Recap Total Resurfacing System. Performance will be assessed trough Harris Hip Score, radiographic evaluation at various postoperative visits. Adverse events and revisions will be documented for safety assessments. Primary endpoints: * Total Harris hip score * Device revisions or removals Secondary endpoints: * Total Harris hip score * Radiographic changes as evidenced by: I. Acetabular component migration, change in angle of inclination or presence of osteolysis II. Femoral component subsidence, femoral neck Fracture or presence of osteolysis
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with a preoperative Total Harris Hip Score of \< 70
- •Conservative treatment has proven unsuccessful
- •Primary hip surgery
- •Patients requiring hip resurfacing for degenerative joint disease (inflammatory or non- inflammatory) or any of the composite diagnoses of:
- •Osteoarthritis
- •Avascular necrosis
- •Legg Perthes
- •Rheumatoid Arthritis
- •Juvenile Rheumatoid Arthritis
- •Systemic Lupus Erythematosus
Exclusion Criteria
- •Patients with a preoperative Total Harris Hip Score of \> 70
- •Previous prosthetic hip replacement device (including other surface arthroplasty, endoprosthesis,etc) in the operative hip
- •Contralateral hip prosthesis (total hip replacement or surface replacement),including staged or simultaneous procedures
- •Developmental dysplasla, which prevents stable acetabular reconstruction
- •Patients with previous Girdlestone procedures
- •Patients with above knee amputation of the contralateral and/or ipsilateral leg
- •Severe osteoarthritis or marked bone loss,which would preclude proper fixation of the prosthetic device(s)
- •Active or suspected systemic or localized Infection
- •Parkinson's or Alzheimer's Disease
- •Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue,which would preclude stability of the prosthesis
Outcomes
Primary Outcomes
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
Time Frame: 2 years postoperative
Secondary Outcomes
- Complications(Anytime)