Durom(R) Hip Resurfacing System Multicenter Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00746616
First received: September 2, 2008
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Advanced Hip Disease
Device: Durom Hip Resurfacing System
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Durom(R) Hip Resurfacing System Multicenter Trial

Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • Device Survival [ Time Frame: All post-op visits until last patient enrolled reaches 2 year follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 6 month post-op and annually until last patient reaches 2 year follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: June 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Hip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty.
Device: Durom Hip Resurfacing System
Hip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty.
Other Name: Hip Reserfacing

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746616

Locations
United States, Colorado
Colorado Joint Replacement
Denver, Colorado, United States, 80210
United States, New York
Syracuse Orthopedic Specialists
De Witt, New York, United States, 13214
United States, Oklahoma
Eastern Oklahoma Orthopedic Center
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
PENN Orthopedics
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Texas Hip and Knee
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Zimmer, Inc.
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT00746616     History of Changes
Other Study ID Numbers: 06-100, G060120/S6
Study First Received: September 2, 2008
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Zimmer, Inc.:
Total Hip Arthroplasty,
Acetabular Cup,
Hip Resurfacing
Young,
active
patients

ClinicalTrials.gov processed this record on October 01, 2014