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Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant

Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial

NCT00962351•Anderson Orthopaedic Research Institute

View on ClinicalTrials.gov

Summary

This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Undergoing cementless primary total hip replacement
•Receiving acetabular cup of 52mm or greater
•Preoperative level of function and pain same as for conventional hip replacement
•Likelihood of obtaining relief of pain and improved function
•Full skeletal maturity
•Ability to follow instructions
•Good general health
•Willing to return for follow-up evaluations
•X-ray evaluation confirming the presence of NIDJD
•Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants

Exclusion Criteria

•Age less than 40 years or greater than 80 years at time of surgery
•Patients templated to receive an acetabular component smaller than 52mm in diameter
•Presence of a previous prosthetic hip replacement device in the hip joint to be operated
•Previous girdlestone procedure or surgical fusion of the hip to be operated
•Acute femoral neck fracture
•Above knee amputation of the contralateral and/or ipsilateral leg
•Patients with a diagnosis of inflammatory degenerative arthritis
•Skeletally immature
•Evidence of active infections that may spread to other areas of the body
•The presence of a highly communicable disease that may limit follow-up
+10 more criteria

Locations (2)

Anderson Orthopaedic Research Institute

Alexandria, Virginia, United States

Department of Orthopaedic Surgery, University of Western Ontario

London, Ontario, Canada

Key Dates

Start Date

October 1, 2003

Primary Completion Date

October 1, 2010

Completion Date

October 1, 2013

Last Updated

August 17, 2015

Enrollment

120

ACTUAL participants

Conditions

Non-inflammatory Degenerative Joint Disease

Interventions

Total Hip Replacement

PROCEDURE

PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella

NCT05253976

Rheumatoid ArthritisNon-inflammatory Degenerative Joint Disease+2 more

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COMPLETED

Evaluation of Post-Operative Recovery in ATTUNE® Total Knee Arthroplasty

NCT02339610

Non-inflammatory Degenerative Joint Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant

Inclusion Criteria

Exclusion Criteria

PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella

Evaluation of Post-Operative Recovery in ATTUNE® Total Knee Arthroplasty

CoMplete™ Acetabular Hip System