Clinical trial NCT00873444: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Post-traumatic Arthritis
Collagen Disorders
Avascular Necrosis
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis
Keywords: Hip
Cementless
Ceramic-on-Metal
Metal-on-Metal
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2009-04-01
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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.

Primary outcomes:
measure: Cobalt metal ion levels in the blood at 2 years post surgery
timeFrame: 2 years post-surgery
Secondary outcomes:
measure: Kaplan-Meier survivorship calculations
timeFrame: Annually
measure: Oxford Hip Score
timeFrame: 6 weeks, 6 months, and Annually
measure: UCLA Score
timeFrame: 6 weeks, 6 months, and Annually
measure: Pain Visual Analogue Scale
timeFrame: 6 weeks, 6 months, and Annually
measure: Harris Hip Score
timeFrame: 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
measure: Radiographic analysis
timeFrame: 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
measure: Blood metal ion levels
timeFrame: pre-discharge, 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Other outcomes:
Locations:
city: Garmisch-Partenkirchen
country: Germany
facility: Klinikum Garmisch-Partenkirchen
Study officials:
References: