A Randomised Study to Compare Metal Ion Release and Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-Metal or a Metal-on-Metal Bearing

Randomised, Controlled, Prospective, Multi-Centre, Post Market Surveillance Study Comparing a Ceramic-on-Metal Bearing and a Metal-on-Metal Bearing in Subjects Requiring Primary Total Hip Arthroplasty for Non-Inflammatory Degenerative Joint Disease

The purpose of this study is to monitor the performance and compare the metal ion release of two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the bearing combinations and will be evaluated at regular intervals using, patient, clinical and x-ray assessments. 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; Avascular Necrosis; Post-traumatic Arthritis; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis; Collagen Disorders
• Intervention / Treatment: Device: Pinnacle™ Acetabular System; Device: Pinnacle™ Acetabular System

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Garmisch-Partenkirchen, Germany
    • Klinikum Garmisch-Partenkirchen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Skeletally mature male or female subjects, aged between 20 and 75 years inclusive at the time of surgery.
• Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
• 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.
• Subjects undergoing unilateral primary total hip replacement who are suitable for a cementless acetabular component and whose femoral and acetabular bone stock is suitable to receive implants, without the requirement for a bone graft.
• Subjects with radiographic evidence and primary diagnosis of non-inflammatory degenerative joint disease (NIDJD).
• Subjects with a pre-operative Harris Hip Score of less than or equal to 70 and a pain rating of at least moderate for the operative hip.

Exclusion Criteria:

• Subjects who, in the opinion of the Investigator, have an existing condition, such as active infections, highly communicable diseases, neurological or musculoskeletal disorders that might affect weight-bearing and metastatic or neoplastic disease, that would compromise their participation and follow-up in this study.
• Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties, unless known to be titanium alloy only.
• Patients who have received a total hip arthroplasty in the contralateral hip within the previous 12 months unless known to be titanium alloy only.
• Subjects who have undergone previous hip surgery on the operative hip (including previous hip/surface replacements, resection arthroplasty or surgical fusion of the hip).
• Subjects requiring a simultaneous bilateral hip operation.
• 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 with an acute femoral neck fracture of the operative hip.
• Subjects who have undergone above knee amputation of the contralateral and/or ipsilateral leg.
• Subjects with compromised renal function.
• Subjects with a known allergy to metal (eg, jewellery).
• Subjects with an occupational exposure to cobalt, chromium, molybdenum, titanium or nickel.
• Subjects who have ingested medication or vitamins containing cobalt, chromium, molybdenum, titanium or nickel within the last 12 months, or intend to ingest such substances over the next 2 years.
• Subjects who have undergone systemic steroid therapy, excluding inhalers, in the three months prior to surgery.
• Women who are pregnant.
• Subjects who are prisoners, known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
• Subjects who have participated in a clinical study with an investigational product in the last 12 months.
• Subjects who are currently involved in any injury litigation claims.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1) Ceramic-on-Metal Bearing; A cementless acetabular cup with ceramic liner for use in total hip replacement	Device: Pinnacle™ Acetabular System; A cementless acetabular cup with ceramic liner for use in total hip replacement; Device: Pinnacle™ Acetabular System; A cementless acetabular cup with metal liner for use in total hip replacement
Active Comparator: 2) Metal-on-Metal Bearing; A cementless acetabular cup with metal liner for use in total hip replacement	Device: Pinnacle™ Acetabular System; A cementless acetabular cup with ceramic liner for use in total hip replacement; Device: Pinnacle™ Acetabular 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
Cobalt metal ion levels in the blood at 2 years post surgery	2 years post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Kaplan-Meier survivorship calculations	Annually
Oxford Hip Score	6 weeks, 6 months, and Annually
UCLA Score	6 weeks, 6 months, and Annually
Pain Visual Analogue Scale	6 weeks, 6 months, and Annually
Harris Hip Score	6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Radiographic analysis	6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Blood metal ion levels	pre-discharge, 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: March 19, 2009
• First Submitted That Met QC Criteria: March 31, 2009
• First Posted (Estimate): April 1, 2009

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Hip; Cementless; Metal-on-Metal; Ceramic-on-Metal
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Bone Diseases, Developmental; Osteochondrodysplasias; Epiphyses, Slipped; Necrosis; Rheumatic Diseases; Collagen Diseases; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses
• Other Study ID Numbers: CT00/37