Status:
TERMINATED
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
Lead Sponsor:
DePuy International
Conditions:
Osteoarthritis
Post-traumatic Arthritis
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00873444
Start Date
July 1 2006
End Date
November 1 2006
Last Update
May 11 2016
Active Locations (1)
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1
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, Germany