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

July 10, 2017 updated by: DePuy Orthopaedics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

265

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Rancho Mirage, California, United States, 92270
        • Desert Orthopaedics
    • Georgia
      • Cumming, Georgia, United States, 30041
        • Resurgens Orthopaedics
    • Illinois
      • Morton Grove, Illinois, United States, 60053
        • Illinois Bone and Joint Institute
    • Michigan
      • Grand Rapids, Michigan, United States, 49503-2550
        • Spectrum Health Hospital Research
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
        • Dartmouth-Hitchcock Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Eastern Oklahoma Orthopedic Center
    • Texas
      • Austin, Texas, United States, 78705
        • Orthopaedic Specialists of Austin
    • Washington
      • Renton, Washington, United States, 98055-5791
        • Valley Orthopaedic Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Acetabular cup replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes
Time Frame: 24-month interval.
"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"
24-month interval.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T-Test of Harris Hip Total Score Means at 24 Months
Time Frame: 24 months
T-Test of Harris Hip total score means at 24 months
24 months
Harris Hip Pain Sub Score at 24 Months
Time Frame: 24 months
Mean Harris Hip Pain sub score
24 months
Harris Hip Function Score at 24 Months
Time Frame: 24 months
Mean Harris Hip Function sub score at 24 months
24 months
Analysis of Metal Ion Release - Serum Cobalt
Time Frame: Pre-operative
Serum Cobalt
Pre-operative
Analysis of Metal Ion Release - Serum Chromium
Time Frame: pre-operative
Serum Chromium
pre-operative
Analysis of Metal Ion Release - Erythrocyte Cobalt
Time Frame: pre-operative
Erythrocyte cobalt
pre-operative
Analysis of Metal Ion Release - Erythrocyte Chromium
Time Frame: Pre-operative
Erythrocyte Chromium
Pre-operative
Analysis of Metal Ion Release - Serum Cobalt
Time Frame: 4 months post-operative
Serum Cobalt
4 months post-operative
Analysis of Metal Ion Release - Serum Chromium
Time Frame: 4 months post operative
Serum Chromium
4 months post operative
Analysis of Metal Ion Release - Erythrocyte Cobalt
Time Frame: 4 months post-operative
Erythrocyte Cobalt
4 months post-operative
Analysis of Metal Ion Release - Erythrocyte Chromium
Time Frame: 4 months post-operative
Erythrocyte Chromium
4 months post-operative
Analysis of Metal Ion Release - Serum Cobalt
Time Frame: 12 months post-operative
Serum Cobalt
12 months post-operative
Analysis of Metal Ion Release - Serum Chromium
Time Frame: 12 Months
Serum Chromium
12 Months
Analysis of Metal Ion Release - Erythrocyte Cobalt
Time Frame: 12 Months
Erythrocyte Cobalt
12 Months
Analysis of Metal Ion Release - Erythrocyte Chromium
Time Frame: 12 months
Erythrocyte Chromium
12 months
Analysis of Metal Ion Release - Serum Cobalt
Time Frame: 24 months
Serum Cobalt
24 months
Analysis of Metal Ion Release - Serum Chromium
Time Frame: 24 months
Serum Chromium
24 months
Analysis of Metal Ion Release - Erythrocyte Cobalt
Time Frame: 24 months
Erythrocyte Cobalt
24 months
Analysis of Metal Ion Release - Erythrocyte Chromium
Time Frame: 24 months
Erythrocyte Chromium
24 months
Analysis of Metal Ion Release - Serum Cobalt
Time Frame: 36 months
Serum Cobalt
36 months
Analysis of Metal Ion Release - Serum Chromium
Time Frame: 36 months
Serum Chromium
36 months
Analysis of Metal Ion Release - Erythrocyte Cobalt
Time Frame: 36 months
Erythrocyte cobalt
36 months
Analysis of Metal Ion Release - Erythrocyte Chromium
Time Frame: 36 months
Erythrocyte chromium
36 months
Analysis of Metal Ion Release - Serum Cobalt
Time Frame: 48 months
Serum Cobalt
48 months
Analysis of Metal Ion Release - Serum Chromium
Time Frame: 48 months
Serum Chromium
48 months
Analysis of Metal Ion Release - Erythrocyte Cobalt
Time Frame: 48 months
Erythrocyte Cobalt
48 months
Analysis of Metal Ion Release - Erythrocyte Chromium
Time Frame: 48 months
Erythrocyte chromium
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2006

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 21, 2007

Study Record Updates

Last Update Posted (Actual)

August 9, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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