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

This study has been terminated.
(Study progress very slow therefore terminated as other projects underway to investigate the same research question which will deliver results earlier)
Sponsor:
Information provided by:
DePuy International
ClinicalTrials.gov Identifier:
NCT00873444
First received: March 19, 2009
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Post-traumatic Arthritis
Collagen Disorders
Avascular Necrosis
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis
Device: Pinnacle™ Acetabular System
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Cobalt metal ion levels in the blood at 2 years post surgery [ Time Frame: 2 years post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Kaplan-Meier survivorship calculations [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Oxford Hip Score [ Time Frame: Annually ] [ Designated as safety issue: No ]
  • UCLA Score [ Time Frame: Annually ] [ Designated as safety issue: No ]
  • Pain Visual Analogue Scale [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Harris Hip Score [ Time Frame: 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]
  • Blood metal ion levels [ Time Frame: pre-discharge, 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: July 2006
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 metal liner for use in total hip replacement

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873444

Locations
Germany
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, Germany
Sponsors and Collaborators
DePuy International
  More Information

No publications provided

Responsible Party: Roy Harvey, Clinical Research Manager, DePuy International Ltd
ClinicalTrials.gov Identifier: NCT00873444     History of Changes
Other Study ID Numbers: CT00/37
Study First Received: March 19, 2009
Last Updated: September 1, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by DePuy International:
Hip
Cementless
Ceramic-on-Metal
Metal-on-Metal

Additional relevant MeSH terms:
Arthritis
Collagen Diseases
Hip Dislocation, Congenital
Hip Dislocation
Necrosis
Osteonecrosis
Osteoarthritis
Slipped Capital Femoral Epiphyses
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Dislocations
Wounds and Injuries
Hip Injuries
Pathologic Processes
Bone Diseases
Rheumatic Diseases
Osteochondrodysplasias
Bone Diseases, Developmental
Epiphyses, Slipped

ClinicalTrials.gov processed this record on July 31, 2014