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

NCT00208364 | Terminated Phase 4

• 1 other identifier: CT01/11
• Study Type: interventional
• Target: 163
• Locations: 2 countries
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Kaplan-Meier survivorship calculated at the 5 year time point.

  5 years

Secondary Outcomes (5)

• Annual Kaplan-Meier survivorship calculationsMetal ion analysis in whole blood

  Annually

• Harris Hip score

  6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery

• Oxford Hip score

  6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery

• Radiological analysis

  6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery

• Metal ion analysis in whole blood

  pre-discharge, 6mths, 1yr, 2 yrs and 5yrs post-surgery

Study Arms (1)

Pinnacle Acetabular Cup System

OTHER

A cementless acetabular cup with metal liner for use in total hip replacement

Device: Pinnacle Acetabular Cup System

Interventions

Pinnacle Acetabular Cup System DEVICE

A cementless acetabular cup with metal liner for use in total hip replacement

Pinnacle Acetabular Cup System

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (2)

Ospedale Riuniti Di Bergamo

Bergamo, Italy

Location

Royal Orthopaedic Hospital

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis; Collagen Diseases; Osteonecrosis; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteochondrodysplasias; Bone Diseases, Developmental; Epiphyses, Slipped

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2004
• Primary Completion: October 1, 2014
• Study Completion: September 1, 2016
• Last Updated: October 7, 2016

Record last verified: 2016-09

Locations

GB (1); IT (1)