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 - Full Text View

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 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

MedlinePlus related topics: Fractures Hip Replacement Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

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 Study Completion Date:	October 2024
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pinnacle Acetabular Cup System A cementless acetabular cup with metal liner for use in total hip replacement	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:

Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy.
Subjects with an occupational exposure to cobalt or chromium.
Subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months.
Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
Subjects who are undergoing a simultaneous bilateral total hip replacement.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208364

Locations

Italy
Ospedale Riuniti Di Bergamo
Bergamo, Italy
United Kingdom
Royal Orthopaedic Hospital
Birmingham, United Kingdom

Sponsors and Collaborators

DePuy International

More Information

No publications provided

Responsible Party:	DePuy International
ClinicalTrials.gov Identifier:	NCT00208364 History of Changes
Other Study ID Numbers:	CT01/11
Study First Received:	September 13, 2005
Last Updated:	October 8, 2012
Health Authority:	Italy: National Institute of Health

Keywords provided by DePuy International:

Hip
Cementless
Metal-on-Metal

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Collagen Diseases
Femoral Fractures
Fractures, Bone
Hip Dislocation, Congenital
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Wounds and Injuries
Leg Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on May 21, 2013