A Prospective Clinical Study On A Total Hip Resurfacing System
This trial is active, not recruiting.
|Conditions||arthritis, avascular necrosis|
|Treatment||recap total hip resurfacing system|
|Start date||October 2004|
|End date||October 2007|
|Trial size||280 participants|
|Trial identifier||NCT00604734, EU-8|
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
ReCap Total Hip Resurfacing System
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
time frame: 2 years postoperative
time frame: Anytime
Male or female participants of any age.
Inclusion Criteria: 1. Patients with a preoperative Total Harris Hip Score of < 70 2. Conservative treatment has proven unsuccessful 3. Primary hip surgery 4. Patients requiring hip resurfacing for degenerative joint disease (inflammatory or non- inflammatory) or any of the composite diagnoses of: 1. Osteoarthritis 2. Avascular necrosis 3. Legg Perthes 4. Rheumatoid Arthritis 5. Juvenile Rheumatoid Arthritis 6. Systemic Lupus Erythematosus 7. Developmental Dysplasia, which does not prevent stable acetabular reconstruction 8. 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: 1. Patients with a preoperative Total Harris Hip Score of > 70 2. Previous prosthetic hip replacement device (including other surface arthroplasty, endoprosthesis,etc) in the operative hip 3. Contralateral hip prosthesis (total hip replacement or surface replacement),including staged or simultaneous procedures 4. Developmental dysplasla, which prevents stable acetabular reconstruction 5. Patients with previous Girdlestone procedures 6. Patients with above knee amputation of the contralateral and/or ipsilateral leg 7. Severe osteoarthritis or marked bone loss,which would preclude proper fixation of the prosthetic device(s) 8. Active or suspected systemic or localized Infection 9. Parkinson's or Alzheimer's Disease 10. Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue,which would preclude stability of the prosthesis 11. Patients less than 18 years of age 12. 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 13. 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 14. Patients with a "fused"hip 15. Patients with metal allergy or hypersensitivity 16. Participation in a study of any investigational product (drug or device) within the past 12 months 17. Prisoners,known drug or alcohol abuser,or mentally incompetent individuals 18. Systemic steroids within 6 months 19. Patients with a known malignancy 20. Patients who are pregnant
|Official title||A Prospective Clinical Study On A Total Hip Resurfacing System|
|Principal investigator||Jo De Schepper, MD|
|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|
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