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A Study to Assess the Long-Term Performance of the Pinnacle Acetabular Cup With a Metal-on-Metal Articulation.
This study is currently recruiting participants.
Verified by DePuy International, June 2008
Sponsored by: DePuy International
Information provided by: DePuy International
ClinicalTrials.gov Identifier: NCT00208364
  Purpose

A post-market surveillance study to evaluate survivorship, clinical and radiological performance of the Pinnacle TM cup with a Metal-on-Metal bearing.


Condition Intervention Phase
Primary Osteoarthritis
Secondary Osteoarthritis
Avascular Necrosis
Developmental Dysplasia of the Hip
Device: Pinnacle Acetabular Cup System
Phase IV

MedlinePlus related topics: Osteoarthritis Osteonecrosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup Prosthesis With a Metal on Metal Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Kaplan-Meier survivorship calculated at the 5 year time point. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Annual Kaplan-Meier survivorship calculations, Harris Hip score, Oxford Hip score and Radiological analysis. Metal ion analysis in whole blood [ Time Frame: Annual ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: April 2004
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Pinnacle Acetabular Cup System
    A cementless acetabular cup with metal liner for use in total hip replacement
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

i) Male or female subjects, aged between 18 and 70 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Subjects undergoing revision hip replacement.

iii) Women who are pregnant.

iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.

vi) Subjects who are currently involved in any injury litigation claims.

Additional Exclusion Criteria for Subjects Having Blood Analysis:

  1. Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy.
  2. Subjects with an occupational exposure to cobalt or chromium.
  3. Subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months.
  4. Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
  5. Subjects who are undergoing a simultaneous bilateral total hip replacement.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208364

Contacts
Contact: Michael Borroff, B.Sc., M.Sc. +44 113 387 7800 ext 7910 mborroff@dpygb.jnj.com

Locations
Italy
Ospedale Riuniti Di Bergamo Recruiting
Bergamo, Italy
United Kingdom
Royal Orthopaedic Hospital Recruiting
Birmingham, United Kingdom
Sponsors and Collaborators
DePuy International
Investigators
Study Director: Michael Borroff, B.Sc., M.Sc. DePuy International Ltd.
  More Information

Responsible Party: DePuy International Ltd ( Michael Borroff )
Study ID Numbers: CT01/11
Study First Received: September 13, 2005
Last Updated: June 20, 2008
ClinicalTrials.gov Identifier: NCT00208364  
Health Authority: Italy: National Institute of Health

Keywords provided by DePuy International:
Hip
Cementless
Metal-on-Metal

Study placed in the following topic categories:
Osteonecrosis
Hip Dislocation
Osteoarthritis
Dislocations
Joint Diseases
Rheumatic Diseases
Bone Diseases
Musculoskeletal Abnormalities
Necrosis
Musculoskeletal Diseases
Arthritis
Neoplasm Metastasis
Congenital Abnormalities
Hip dislocation
Hip Dislocation, Congenital

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009