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

September 2, 2008
April 2, 2013
June 2007
March 2011   (final data collection date for primary outcome measure)
Device Survival [ Time Frame: All post-op visits until last patient enrolled reaches 2 year follow-up ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00746616 on ClinicalTrials.gov Archive Site
Efficacy [ Time Frame: 6 month post-op and annually until last patient reaches 2 year follow-up ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Durom(R) Hip Resurfacing System Multicenter Trial
Durom(R) Hip Resurfacing System Multicenter Trial

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Hip Disease
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
Experimental: 1
Hip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty.
Intervention: Device: Durom Hip Resurfacing System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00746616
06-100, G060120/S6
No
Zimmer, Inc.
Zimmer, Inc.
Not Provided
Not Provided
Zimmer, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP