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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:
ClinicalTrials.gov Identifier:
NCT00873444
First Posted: April 1, 2009
Last Update Posted: May 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DePuy International
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

Enrollment: 5
Study Start Date: July 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873444


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

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00873444     History of Changes
Other Study ID Numbers: CT00/37
First Submitted: March 19, 2009
First Posted: April 1, 2009
Last Update Posted: May 11, 2016
Last Verified: March 2016

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

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