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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

November 20, 2007
April 7, 2014
November 2006
January 2012   (final data collection date for primary outcome measure)
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"
1. Harris Hip Evaluation 2. Hip dysfunction and Osteoarthritis Outcome Score (HOOS) Hip Survey 3. X-rays [ Time Frame: Pre-operative, 1, 4, 12, 24, 36, 48 and 60 month intervals. ]
Complete list of historical versions of study NCT00561600 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Non-inflammatory Degenerative Joint Disease
  • 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
  • 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
  • Active Comparator: A
    ASR™-XL Modular Acetabular Cup System stem
    Intervention: Device: ASR™-XL Modular Acetabular Cup System
  • Active Comparator: B
    Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.
    Intervention: Device: Pinnacle™ acetabular shell
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
265
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00561600
04062
No
DePuy Orthopaedics
DePuy Orthopaedics
Not Provided
Study Director: Dave Whalen, BS, DC DePuy Orthopaedics
DePuy Orthopaedics
April 2014

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