In This SectionTexas Health Research & Education Institute
Clinical Trials
Disease or Condition
Osteoarthritis / Hip Replacement
Title
ReCap Total Resurfacing System (Osteoarthritis / Hip Replacement)
Description
This study is for patients with degenerative joint disease of the hip. The purpose of this research study is to look at the safety and effectiveness of the ReCapÒ Total Resurfacing System in reducing pain, discomfort and/or loss of function patients are currently having in their hip. The ReCap Total Resurfacing system is not FDA approved except for research. The ReCapÒ Total Resurfacing System consists of two (2) implant devices: 1. The femoral head is the ball attached to the thighbone in your leg. The metal resurfacing device is designed to replace the outer surface of your femoral head with a metal "cap" while saving as much natural bone as possible; 2. The acetabulum is the socket in your hip bone into which the femoral head fits. A metal liner will replace your natural acetabulum (socket). This liner is similar to the "socket" devices used in common total hip replacements.
IRB Number
Pro0083
Inclusion/Notes
INCLUSION:
Patients with a pre-operative 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, Avasular Necrosis, Legg Perthes, Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Systemic Lupus Erythematosus, Developmental Dysplasia, which does not prevent stable acetabular reconstruction, Post-traumatic Arthritis
Patients at least 18 years of age
Patients of all races and gender
Patients who are able to follow post-operative care instructions
Patients who are willing and able to return for scheduled follow-up evaluations
Patient has signed the IRB approved Informed Consent form
EXCLUSION:
Patients with a pre-operative 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 dysplasia, 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 condition that may limit follow-up, including: immuno-compromised conditions, hepatitis, active tuberculosis, active neoplastic disease such as carcinoma of the prostate, lung, stomach, cervix, etc., chronic renal failure, organ transplant recipients, known terminal disease process
Patients with a "fused" hip
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
