Non-inflammatory Joint Diseases
Conditions
Keywords
Non-Inflammatory Degenerative Joint Disease
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.
Interventions
DEVICETotal Hip Replacement
Total hip replacement
DEVICETotal hip replacement
Total hip replacement
Sponsors
DePuy Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Success/Failure | At 24 months | The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/\< 2mm, acetabular migration =/\< 2mm, cup inclination =/\< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place. |
Countries
Canada, United States
Participant flow
Recruitment details
Eleven sites enrolled 392 subjects who were then randomized into two groups. The investigational group, Ceramic-on-Metal (COM) and the control group, Metal-on-Metal (MOM). Two subjects were intraoperatively excluded, resulting in 194 subjects COM subjects and 196 MOM subjects.
Participants by arm
| Arm | Count |
|---|---|
| Ceramic-on-Metal (COM) Total Hip Implant The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert. | 194 |
| Metal-on-Metal (MOM) Total Hip Implant The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert. | 196 |
| Total | 390 |
Baseline characteristics
| Characteristic | Ceramic-on-Metal (COM) Total Hip Implant | Metal-on-Metal (MOM) Total Hip Implant | Total |
|---|---|---|---|
| Age Continuous Age | 58.9 Years STANDARD_DEVIATION 10.1 | 59.1 Years STANDARD_DEVIATION 9.5 | 59 Years STANDARD_DEVIATION 9.78 |
| Region of Enrollment United States | 194 participants | 196 participants | 390 participants |
| Sex: Female, Male Female | 83 Participants | 91 Participants | 174 Participants |
| Sex: Female, Male Male | 111 Participants | 105 Participants | 216 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 137 / 194 | 125 / 196 |
| serious Total, serious adverse events | 40 / 194 | 48 / 196 |
Outcome results
Primary
Composite Success/Failure
The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/\< 2mm, acetabular migration =/\< 2mm, cup inclination =/\< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place.
Time frame: At 24 months
Population: Out of the 390 subjects, 84 subjects were removed from the analysis for the following reasons: 2 deaths (1 in each arm); 3 protocol violations (2 COM, 1 MOM); 28 bilateral (12 COM, 16 MOM); 39 subjects had no 24-month Harris Hip score (22 COM, 17 MOM); and 12 subjects had no 24-month x-ray (4 COM, 8 MOM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ceramic-on-Metal (COM) Total Hip Implant | Composite Success/Failure | 142 Participants |
| Metal-on-Metal (MOM) Total Hip Implant | Composite Success/Failure | 141 Participants |