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

Anderson Orthopaedic Research Institute

Status

Completed

Conditions

Non-inflammatory Degenerative Joint Disease

Treatments

Procedure: Total Hip Replacement

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00962351

AORI2009-0100

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No 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
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