Clinical trial NCT00208494: Metal on Metal Versus Ceramic on Metal Hip Replacement
Official title: Comparative Study to Evaluate the Safety and Efficacy of the DePuy Ceramic-on-metal Total Hip Prosthesis Versus the DePuy Metal-on-metal Total Hip Prosthesis Through Clinical and Radiographical Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-inflammatory Joint Diseases
Keywords: Non-Inflammatory Degenerative Joint Disease
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 392
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components. The success of the total hip arthroplasty (THA) will be based upon all of the following clinical and radiographic criteria being met at the two-year evaluation: (1) the patient's clinical results as measured using modified Harris Hip evaluation rating system, and the absence of a complication that requires the surgical removal or replacement of a component; and (2) radiographic findings at study endpoint (i.e., two years follow-up). Clinical and radiographic success at two (2) years postoperative is required for the study hip to be deemed successful.

Detailed description: This study is a prospective, multi-center, randomized, single blind, controlled clinical investigation comparing the safety and efficacy of the cementless Ceramic on Metal total hip prostheses versus the cementless Metal on Metal total hip prostheses.

Eligibility criteria: Inclusion Criteria:

* Able to (or capable of) provide consent to participate in the clinical investigation prior to the day of the surgery.
* Skeletally mature (tibial and femoral epiphyses are closed)
* Undergoing cementless primary hip replacement surgery for Noninflammatory Degenerative Joint Disease
* Affected hip has a Harris Hip Score of 70 or lower and a Pain rating of Moderate or greater
* Radiographic Parameters:
* X-Ray Evaluation confirms the presence of NIDJD
* Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants
* No structural bone grafts required to support to prosthetic component(s)or to shape the bone to receive implant(s)
* Willing to have knowledge of treatment arm (CoM or MoM) withheld for a period of 24 months post-operatively unless disclosure is legally and/or medically necessary
* Previous THA in contralateral hip that is greater than one (1) year postoperative and has a Harris Hip pain rating less than MILD

Exclusion Criteria:

* Bilateral hip disease with the anticipated need for bilateral hip implant during study participation (i.e., within the next 24 months)
* THA required for the revision of a previously failed THA
* Suffering from inflammatory arthritis
* Prior prosthetic hip replacement
* Previous Girdlestone procedure or surgical fusion in the operative hip joint
* Above knee amputation of either the contralateral or ipsilateral leg
* Known allergy to metal (e.g. jewelry)
* The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.)
* Significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis)
* Conditions that may interfere with the total hip arthroplasty survival or outcome (e.g., Paget's disease, Charcot's disease)
* Unwilling or unable to comply with a rehabilitation program for a cementless THA or difficulty or inability to return for follow-up visits prescribed by the study protocol
* Known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
* Previous treatment for renal disease
* Any systemic steroid therapy, excluding inhalers, within three months prior to surgery

Primary outcomes:
measure: Composite Success/Failure
timeFrame: At 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Foundation for Musculoskeletal Research and Education
state: Arkansas
city: Orange
country: United States
state: California
city: Palm Bay
country: United States
state: Florida
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Alexandria
country: United States
facility: Anderson Clinic
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: London
country: Canada
state: Ontario
Study officials:
affiliation: Orthopaedic Specialty Clinic
name: David Scott, MD
role: PRINCIPAL_INVESTIGATOR
name: Patrick G Kirk, MD
role: PRINCIPAL_INVESTIGATOR
name: Shekhar S Desai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anderson Clinic
name: Charles A Engh, Jr., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Adult Orthopaedic Reconstruction Texas Hip and Knee Center
name: Ajai Cadambi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Foundation for Musculoskeletal Research & Education
name: C L Barnes, MD
role: PRINCIPAL_INVESTIGATOR
References: