Durom(R) Hip Resurfacing System Multicenter Trial

Zimmer Biomet

Status and phase

Completed

Phase 3

Conditions

Advanced Hip Disease

Treatments

Device: Durom Hip Resurfacing System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00746616

06-100

G060120/S6

Details and patient eligibility

About

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.

Full description

Safety will be evaluated based on the frequency and incidence of any device related adverse events or unanticipated adverse device events. The efficacy will be measured by comparing the overall functional performance based on the Harris Hip Score, implant survivorship, and radiographic parameters, including radiolucencies, osteolysis, stem subsidence, cup migration, and change in cup angle and a change in the femoral shaft angle.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.