Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00604734
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00604734
Study Brief:
Protocol Section:
NCT00604734