Clinical trial NCT00208364: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Osteoarthritis
Post-traumatic Arthritis
Collagen Disorders
Avascular Necrosis
Traumatic Femoral Fractures
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis
Keywords: Hip
Cementless
Metal-on-Metal
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Kaplan-Meier survivorship calculated at the 5 year time point.
timeFrame: 5 years
Secondary outcomes:
measure: Annual Kaplan-Meier survivorship calculationsMetal ion analysis in whole blood
timeFrame: Annually
measure: Harris Hip score
timeFrame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
measure: Oxford Hip score
timeFrame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
measure: Radiological analysis
timeFrame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
measure: Metal ion analysis in whole blood
timeFrame: pre-discharge, 6mths, 1yr, 2 yrs and 5yrs post-surgery
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Ospedale Riuniti Di Bergamo
city: Birmingham
country: United Kingdom
facility: Royal Orthopaedic Hospital
Study officials:
References: