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A Two Centre Study to Assess the Long-Term Performance of the Pinnacle™ Cup With a Metal-on-Metal Bearing in Primary Total Hip Replacement
This study is currently recruiting participants.
Verified by DePuy International, March 2009
First Received: September 13, 2005   Last Updated: March 30, 2009   History of Changes
Sponsored by: DePuy International
Information provided by: DePuy International
ClinicalTrials.gov Identifier: NCT00208364
  Purpose

The purpose of this study is to monitor the performance and determine the metal ion release of the Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.


Condition Intervention Phase
Rheumatoid Arthritis
Osteoarthritis
Post-Traumatic Arthritis
Collagen Disorders
Avascular Necrosis
Traumatic Femoral Fractures
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis
Device: Pinnacle Acetabular Cup System
Phase IV

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

Resource links provided by NLM:


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 calculationsMetal ion analysis in whole blood [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Harris Hip score [ Time Frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Oxford Hip score [ Time Frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Radiological analysis [ Time Frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Metal ion analysis in whole blood [ Time Frame: pre-discharge, 6mths, 1yr, 2 yrs and 5yrs post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2004
Estimated Primary Completion Date: March 2015 (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@its.jnj.com

Locations
Italy
Ospedale Riuniti Di Bergamo Active, not 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

No publications provided

Responsible Party: DePuy International Ltd ( Michael Borroff, B.Sc. M.Sc., Study Director )
Study ID Numbers: CT01/11
Study First Received: September 13, 2005
Last Updated: March 30, 2009
ClinicalTrials.gov Identifier: NCT00208364     History of Changes
Health Authority: Italy: National Institute of Health

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

Study placed in the following topic categories:
Autoimmune Diseases
Osteonecrosis
Collagen Diseases
Hip Dislocation
Osteoarthritis
Dislocations
Joint Diseases
Fractures, Bone
Wounds and Injuries
Arthritis, Rheumatoid
Disorders of Environmental Origin
Rheumatic Diseases
Bone Diseases
Musculoskeletal Abnormalities
Femoral Fractures
Necrosis
Musculoskeletal Diseases
Epiphyses, Slipped
Arthritis
Connective Tissue Diseases
Hip Dysplasia
Leg Injuries
Congenital Abnormalities
Hip Dislocation, Congenital

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Collagen Diseases
Osteonecrosis
Osteoarthritis
Joint Diseases
Fractures, Bone
Wounds and Injuries
Arthritis, Rheumatoid
Disorders of Environmental Origin
Rheumatic Diseases
Bone Diseases
Musculoskeletal Abnormalities
Femoral Fractures
Necrosis
Pathologic Processes
Musculoskeletal Diseases
Epiphyses, Slipped
Arthritis
Connective Tissue Diseases
Leg Injuries
Congenital Abnormalities
Hip Dislocation, Congenital

ClinicalTrials.gov processed this record on August 30, 2009