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In This Section Texas 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 ReCapĂ’ 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 ReCapĂ’ 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

  • Systemic steroids within 6 months

  • Patients with a known malignancy

  • Patients who are pregnant
Status   Completed
Location   Texas Health Plano
Principal Name    John Wesley Barrington MD
Contact Name   Mary Jenson
Phone   (972) 608-8868 226

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