Durom(R) Hip Resurfacing System Multicenter Trial

Completed · Phase 3

Conditions studied: Advanced Hip Disease

In brief

The purpose of the study is to gather clinical information on the safety and efficacy of the resurfacing devices in the young, active patient with advanced hip disease. Study enrollment has been temporarily suspended due to a change in the surgical technique.

Key facts

Study ID

NCT00746616

Run by

Zimmer Biomet

People needed

40

Starts

2007-06-01

Expected to finish

2011-03-01

Last updated by the study team

2013-04-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient selection without bias to race or gender
• Patient is greater than or equal to 18 and less than or equal to 65 years of age.
• Female patients only:
• actively practicing a contraceptive method, or
• surgically sterilized, or
• post-menopausal
• Pre-operative Harris Hip Score less than or equal to 70.
• Primary surgical hip candidate, suffering from hip pain and/or disability due to degenerative joint disease (inflammatory or non-inflammatory), based on physical examination and history, including the following diagnosis:
• non-inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis or osteoarthritis
• inflammatory joint disease (IJD), e.g. rheumatoid arthritis
• Patient is willing and able to cooperate in prescribed post-operative therapy.
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
• Patient has participated in the Informed Consent process and has signed and IRB approved Informed Consent.

You may not qualify if…

• Patient with an acute, chronic, local or systemic infection.
• Patient who is skeletally immature.
• Patient with a severe muscular, neural or vascular disease that endangers the involved extremity.
• Patient with an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible, including but not limited to:
• patient with severe osteopenia
• patients with a family history of severe osteoporosis or osteopenia
• patients with osteonecrosis or avascular necrosis (AVN) with > 50% involvement of the femoral head (regardless of FICAT grade)
• patients with multiple cysts of the femoral head > 1cm
• Patient with total or partial absence of the muscular of ligamentous apparatus.
• Patient has known moderate to severe renal insufficiency.
• Patient with a known clinical condition which may interfere with patient outcome, including but not limited to:
• immuno-compromised conditions (AIDS),
• organ transplant recipient,
• high doses of corticosteroids etc
• Patient who is severely overweight (BMI >40)
• Operative (ipsilateral) Hip: Patient has a total prosthetic hip replacement device, surface arthroplasty or endoprosthesis.
• Contralateral Hip: Patient has had hip replacement, surface arthroplasty or endoprosthesis, within the past 12 months, unless already enrolled in this investigational study.
• Patient who is:
• a prisoner
• mentally incompetent
• a known alcohol or drug abuser
• anticipated to be non-compliant
• Patient who has participated in a study of any other investigational device (drug, device or biologic) within the past 12 months. Exception: previous enrollment in the Durom Hip Resurfacing System clinical study.
• Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.

Where it is running

• Colorado Joint Replacement — Denver, Colorado, United States
• Syracuse Orthopedic Specialists — De Witt, New York, United States
• Eastern Oklahoma Orthopedic Center — Tulsa, Oklahoma, United States
• PENN Orthopedics — Philadelphia, Pennsylvania, United States
• Texas Hip and Knee — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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