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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00873444
• Other study ID #: CT00/37
• Status: Terminated
• Phase: Phase 4
• First received: March 19, 2009
• Last updated: May 9, 2016
• Start date: July 2006
• Est. completion date: November 2006

Study information

• Verified date: March 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Avascular Necrosis
• Collagen Diseases
• Collagen Disorders
• Congenital Hip Dysplasia
• Hip Dislocation, Congenital
• Osteoarthritis
• Post-traumatic Arthritis
• Slipped Capital Femoral Epiphyses
• Slipped Capital Femoral Epiphysis

Intervention

Device:
• Pinnacle™ Acetabular System
A cementless acetabular cup with ceramic liner for use in total hip replacement
• Pinnacle™ Acetabular System
A cementless acetabular cup with metal liner for use in total hip replacement

Locations

Country	Name	City	State
Germany	Klinikum Garmisch-Partenkirchen	Garmisch-Partenkirchen

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cobalt metal ion levels in the blood at 2 years post surgery		2 years post-surgery	No
Secondary	Kaplan-Meier survivorship calculations		Annually	Yes
Secondary	Oxford Hip Score		6 weeks, 6 months, and Annually	No
Secondary	UCLA Score		6 weeks, 6 months, and Annually	No
Secondary	Pain Visual Analogue Scale		6 weeks, 6 months, and Annually	Yes
Secondary	Harris Hip Score		6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery	No
Secondary	Radiographic analysis		6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery	No
Secondary	Blood metal ion levels		pre-discharge, 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery	No