Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00561600
First received: November 20, 2007
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.


Condition Intervention
Non-inflammatory Degenerative Joint Disease
Device: ASR™-XL Modular Acetabular Cup System
Device: Pinnacle™ acetabular shell

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Comparative, Multi-Center Clinical Evaluation of the DePuy ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System Study

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes [ Time Frame: 24-month interval. ] [ Designated as safety issue: Yes ]

    "Composite success:

    1. Revision free (life of study)
    2. No evidence of radiographic failure (life of study)
    3. Harris Hip score => 80 at 24 months"


Secondary Outcome Measures:
  • T-Test of Harris Hip Total Score Means at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    T-Test of Harris Hip total score means at 24 months

  • Harris Hip Pain Sub Score at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Mean Harris Hip Pain sub score

  • Harris Hip Function Score at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Mean Harris Hip Function sub score at 24 months

  • Analysis of Metal Ion Release - Serum Cobalt [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]
    Serum Cobalt

  • Analysis of Metal Ion Release - Serum Chromium [ Time Frame: pre-operative ] [ Designated as safety issue: Yes ]
    Serum Chromium

  • Analysis of Metal Ion Release - Erythrocyte Cobalt [ Time Frame: pre-operative ] [ Designated as safety issue: No ]
    Erythrocyte cobalt

  • Analysis of Metal Ion Release - Erythrocyte Chromium [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]
    Erythrocyte Chromium

  • Analysis of Metal Ion Release - Serum Cobalt [ Time Frame: 4 months post-operative ] [ Designated as safety issue: No ]
    Serum Cobalt

  • Analysis of Metal Ion Release - Serum Chromium [ Time Frame: 4 months post operative ] [ Designated as safety issue: No ]
    Serum Chromium

  • Analysis of Metal Ion Release - Erythrocyte Cobalt [ Time Frame: 4 months post-operative ] [ Designated as safety issue: No ]
    Erythrocyte Cobalt

  • Analysis of Metal Ion Release - Erythrocyte Chromium [ Time Frame: 4 months post-operative ] [ Designated as safety issue: No ]
    Erythrocyte Chromium

  • Analysis of Metal Ion Release - Serum Cobalt [ Time Frame: 12 months post-operative ] [ Designated as safety issue: No ]
    Serum Cobalt

  • Analysis of Metal Ion Release - Serum Chromium [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Serum Chromium

  • Analysis of Metal Ion Release - Erythrocyte Cobalt [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Erythrocyte Cobalt

  • Analysis of Metal Ion Release - Erythrocyte Chromium [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Erythrocyte Chromium

  • Analysis of Metal Ion Release - Serum Cobalt [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Serum Cobalt

  • Analysis of Metal Ion Release - Serum Chromium [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Serum Chromium

  • Analysis of Metal Ion Release - Erythrocyte Cobalt [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Erythrocyte Cobalt

  • Analysis of Metal Ion Release - Erythrocyte Chromium [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Erythrocyte Chromium

  • Analysis of Metal Ion Release - Serum Cobalt [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Serum Cobalt

  • Analysis of Metal Ion Release - Serum Chromium [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Serum Chromium

  • Analysis of Metal Ion Release - Erythrocyte Cobalt [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Erythrocyte cobalt

  • Analysis of Metal Ion Release - Erythrocyte Chromium [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Erythrocyte chromium

  • Analysis of Metal Ion Release - Serum Cobalt [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    Serum Cobalt

  • Analysis of Metal Ion Release - Serum Chromium [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    Serum Chromium

  • Analysis of Metal Ion Release - Erythrocyte Cobalt [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    Erythrocyte Cobalt

  • Analysis of Metal Ion Release - Erythrocyte Chromium [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    Erythrocyte chromium


Enrollment: 265
Study Start Date: November 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
ASR™-XL Modular Acetabular Cup System stem
Device: ASR™-XL Modular Acetabular Cup System
The ASR™-XL Modular Acetabular Cup System treatment device is comprised of a metal acetabular cup, a unipolar femoral head and a taper sleeve adapter.
Other Name: Acetabular cup replacement
Active Comparator: B
Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.
Device: Pinnacle™ acetabular shell
The Pinnacle™ shells are cementless, titanium alloy cups with Porocoat® porous coating and HA DuoFix™ coating. There are various different liners available for use with the Pinnacle™ Acetabular Cup System. For the purpose of this investigation, the CoCrMo ULTAMET® 28mm or 36 mm metal liners will be used.
Other Name: Acetabular cup replacement

Detailed Description:

The purpose of this clinical investigation is to gather sufficient clinical and radiographic data to permit valid scientific comparisons between treatment and control group outcomes. The treatment group/device for this study is the ASR™-XL Acetabular Cup System, and the control group/device is the Pinnacle™ Cup System w/ the 28mm or 36mm ULTAMET™ metal liner. The study objective will be achieved by way of treatment group selection, treatment administration, and management of participating study Subjects.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is able to or capable of providing consent to participate in the clinical investigation.
  • Subject is between the ages of 20-75 years, inclusive.
  • Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD).
  • Subject has sufficient bone stock for the hip replacement device.
  • Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either cup system device.

Exclusion Criteria:

  • Subject, in the opinion of the Investigator, has an existing condition that would compromise his/her participation and follow-up in this investigation.
  • Subject with a known allergy to metal (e.g. jewelry).
  • Subject has inflammatory arthritis (e.g. rheumatoid arthritis).
  • Subject has active or recent joint sepsis.
  • Subject with marked atrophy or deformity in the upper femur.
  • Subject with a neuromuscular disease where the loss of musculature would affect functional outcome.
  • Subject, in the opinion of the Clinical Investigator, has a history of chronic renal insufficiency (e.g. dialysis).
  • Subject is receiving systemic steroid therapy, excluding inhalers or intra-capsular injections, within 3 months prior to surgery.
  • Subject with known, active metastatic or neoplastic disease.
  • Subject is known to be pregnant, a prisoner, mentally incompetent, and or alcohol or drug abuser.
  • Subject is currently involved in any personal injury litigation, medical legal or worker's compensation claims.
  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: NCT00561600

Locations
United States, California
Desert Orthopaedics
Rancho Mirage, California, United States, 92270
United States, Georgia
Resurgens Orthopaedics
Cumming, Georgia, United States, 30041
United States, Illinois
Illinois Bone and Joint Institute
Morton Grove, Illinois, United States, 60053
United States, Michigan
Spectrum Health Hospital Research
Grand Rapids, Michigan, United States, 49503-2550
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
United States, Oklahoma
Eastern Oklahoma Orthopedic Center
Tulsa, Oklahoma, United States, 74136
United States, Texas
Orthopaedic Specialists of Austin
Austin, Texas, United States, 78705
United States, Washington
Valley Orthopaedic Associates
Renton, Washington, United States, 98055-5791
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Dave Whalen, BS, DC DePuy Orthopaedics
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00561600     History of Changes
Other Study ID Numbers: 04062
Study First Received: November 20, 2007
Results First Received: February 5, 2014
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by DePuy Orthopaedics:
Hip arthroplasty
Acetabular cup replacement
Acetabulum arthroplasty

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 30, 2014