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

NCT ID: NCT00962351

Last Updated: 2015-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2013-10-31

Brief 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.

Conditions

Non-inflammatory Degenerative Joint Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Metal-on-Polyethylene

Group Type: OTHER

Total Hip Replacement

Intervention Type: PROCEDURE

Metal-on-Metal, 28mm femoral head

Group Type: OTHER

Total Hip Replacement

Intervention Type: PROCEDURE

Metal-on-Metal, 36mm femoral head

Group Type: OTHER

Total Hip Replacement

Intervention Type: PROCEDURE

Interventions

Total Hip Replacement

Intervention Type: PROCEDURE

Eligibility Criteria

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
• Presence of known active metastatic or neoplastic disease
• Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing
• Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome
• Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up
• Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
• Any patient who qualifies for inclusion in the study but refuses consent to participate in the study
• Any steroid therapy, local or systemic, within three months prior to surgery
• Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants
• Patient has known allergies to metal, e.g., jewelry
• Any patient not meeting all radiographic and clinical parameters for inclusion

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: collaborator

DePuy Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Anderson Orthopaedic Research Institute

OTHER

Sponsor Role: lead

Responsible Party

C. Anderson Engh, Jr., MD

Orthopaedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

C. Anderson Engh, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Anderson Orthopaedic Research Institute

Steven J. MacDonald, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedic Surgery, University of Western Ontario

Locations

Anderson Orthopaedic Research Institute

Alexandria, Virginia, United States

Department of Orthopaedic Surgery, University of Western Ontario

London, Ontario, Canada

Countries

United States; Canada

References

Engh CA Jr, MacDonald SJ, Sritulanondha S, Thompson A, Naudie D, Engh CA. 2008 John Charnley award: metal ion levels after metal-on-metal total hip arthroplasty: a randomized trial. Clin Orthop Relat Res. 2009 Jan;467(1):101-11. doi: 10.1007/s11999-008-0540-9. Epub 2008 Oct 15.

Reference Type: RESULT

PMID: 18855089 (View on PubMed)

Other Identifiers

AORI2009-0100

Identifier Type: -

Identifier Source: org_study_id