A Prospective Clinical Study On A Total Hip Resurfacing System

Study Overview
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Brief Summary
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This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.

Detailed Description
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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

Official Title
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A Prospective Clinical Study On A Total Hip Resurfacing System

Conditions
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Arthritis, Avascular Necrosis

Intervention / Treatment
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* Device: ReCap Total Hip Resurfacing System


Participation Criteria
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Eligibility Criteria
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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 Developmental Dysplasia, which does not prevent stable acetabular reconstruction Post traumatic arthritis S. Patients at least 18 years of age 6. Patients of all races and gender 7. Patients who are able to follow post-operative care instructions 8. Patients who are willing and able to return for scheduled follow-up evaluations 9. Patient has signed the IRB approved Informed Consent Form 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 Patients less than 18 years of age Patients with condition(s) that may Interfere with the survival of the femoral resurfacing or acetabular replacements or their outcomes,including Paget's Disease, Charcot's Disease, Sickle Cell Anemia or traits Severe osteoporosis compromising bone stock (I.e.Dorr type C bone Lower extremity muscular atrophy Neuromuscular disease Patients with a clinical conditions that may limit follow-up,including: immunocompromised conditions, hepatitis, active tuberculosis, neoplastic disease, chronic renal failure, organ transplant recipients, known terminal disease process Patients with a fusedhip Patients with metal allergy or hypersensitivity Participation in a study of any investigational product (drug or device) within the past 12 months Prisoners,known drug or alcohol abuser,or mentally incompetent individuals Systemic steroids within 6 months Patients with a known malignancy Patients who are pregnant
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ReCap<br>ReCap Total Hip Resurfacing System | Device: ReCap Total Hip Resurfacing System<br>* This is a hip resurfacing system.<br>* Other names: ReCap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score, Device Revision/Removal, Radiographic Evaluation |  | 2 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | Anytime |