A Prospective Clinical Study On A Total Hip Resurfacing System

Official Title: “A Prospective Clinical Study On A Total Hip Resurfacing System”

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

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

Intervention(s) in this Clinical Trial

• Device: ReCap Total Hip Resurfacing System
  • This is a hip resurfacing system.

Arms, Groups and Cohorts in this Clinical Trial

• Other: ReCap
  • ReCap Total Hip Resurfacing System

Primary Measures

• Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
  • Time Frame: 2 years postoperative
    Safety Issue?: Yes

Secondary Measures

• Complications
  • Time Frame: Anytime
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Biomet, Inc. Industry

Overall Clinical Trial Officials and Contacts

H P Delport, MD Principal Investigator AZ NIKOLAAS CAMPUS SINT NIKLAAS  

Overall Contact: Fabienne Lambert 32-3 870 65 77 fabienne.lambert@biomet.com

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00604734

Study ID Number: EU-8

ClinicalTrials.gov Identifier: NCT00604734

Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment