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

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Post-traumatic Arthritis; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis; Collagen Disorders; Traumatic Femoral Fractures; Nonunion of Femoral Fractures
• Intervention / Treatment: Device: Pinnacle Acetabular Cup System

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Kaplan-Meier survivorship calculated at the 5 year time point.	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): October 7, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Hip; Cementless; Metal-on-Metal
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Bone Diseases, Developmental; Osteochondrodysplasias; Epiphyses, Slipped; Femoral Fractures; Arthritis; Necrosis; Fractures, Bone; Rheumatic Diseases; Collagen Diseases; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses
• Other Study ID Numbers: CT01/11