Clinical trial NCT00962351: Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant
Official title: Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-inflammatory Degenerative Joint Disease
Keywords: total hip replacement
primary cementless total hip arthroplasty
metal ion
metal-on-metal
Lead sponsor: Anderson Orthopaedic Research Institute
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
name: DePuy Orthopaedics
First posted: 2009-08-20
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: cobalt, chromium, and titanium ion levels in blood and urine
timeFrame: Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years
Secondary outcomes:
measure: Hip function
timeFrame: Pre-op, 6 months,1 year, 2 years, 3 years, 5 years
measure: Durability
timeFrame: 6 months, 1 year, 2 years, 3 years, 5 years
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: Anderson Orthopaedic Research Institute
state: Virginia
city: London
country: Canada
facility: Department of Orthopaedic Surgery, University of Western Ontario
state: Ontario
Study officials:
affiliation: Anderson Orthopaedic Research Institute
name: C. Anderson Engh, Jr., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopaedic Surgery, University of Western Ontario
name: Steven J. MacDonald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.