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.

Study Overview

• Status: Completed
• Conditions: Advanced Hip Disease
• Intervention / Treatment: Device: Durom Hip Resurfacing System

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Joint Replacement
  • New York
    • De Witt, New York, United States, 13214
      • Syracuse Orthopedic Specialists
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Eastern Oklahoma Orthopedic Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • PENN Orthopedics
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Texas Hip and Knee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Hip Reserfacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Device Survival	All post-op visits until last patient enrolled reaches 2 year follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy	6 month post-op and annually until last patient reaches 2 year follow-up

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: September 2, 2008
• First Submitted That Met QC Criteria: September 3, 2008
• First Posted (ESTIMATE): September 4, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 10, 2013
• Last Update Submitted That Met QC Criteria: April 2, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: patients; Hip Resurfacing; active; Total Hip Arthroplasty,; Acetabular Cup,; Young,
• Other Study ID Numbers: 06-100; G060120/S6