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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Ceramic-on-metal total hip implant |
|
| B | Active Comparator | Metal-on-metal total hip implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Replacement | Device | Total hip replacement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Scott, MD | Orthopaedic Specialty Clinic | Principal Investigator |
| Patrick G Kirk, MD | Principal Investigator | |
| Shekhar S Desai, MD | Principal Investigator | |
| Charles A Engh, Jr., MD | Anderson Clinic | Principal Investigator |
| Ajai Cadambi, MD | Adult Orthopaedic Reconstruction Texas Hip and Knee Center | Principal Investigator |
| C L Barnes, MD | Foundation for Musculoskeletal Research & Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation for Musculoskeletal Research and Education | Little Rock | Arkansas | 72203 | United States | ||
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Metal-on-Metal (MOM) Total Hip Implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Number | Participants | At 24 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone Fracture | Musculoskeletal and connective tissue disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Trochanteric Bursitis | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Hoag, MS, Project Leader, Clinical Research | DePuy Orthopaedics, Inc. | 574-372-7399 | JHoag2@its.jnj.com |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Total hip replacement | Device | Total hip replacement |
|
|
| Orange |
| California |
| 92868 |
| United States |
| Palm Bay | Florida | 32905 | United States |
| Charlotte | North Carolina | 28207 | United States |
| Cincinnati | Ohio | 45236 | United States |
| Anderson Clinic | Alexandria | Virginia | 22306 | United States |
| Roanoke | Virginia | 24018 | United States |
| Spokane | Washington | 99218 | United States |
| London | Ontario | N6A 5A5 | Canada |
The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert. |
| OG001 | 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. |
|
|
| 40 |
| 194 |
| 137 |
| 194 |
| EG001 | 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. | 48 | 196 | 125 | 196 |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Cardiovascular | Cardiac disorders |
|
| Central Nervous System | Nervous system disorders |
|
| Constitutional Symptom | General disorders |
|
| Dermatological | Skin and subcutaneous tissue disorders |
|
| Dislocation | Musculoskeletal and connective tissue disorders |
|
| Gastrointestinal | Gastrointestinal disorders |
|
| Genitourinary | Renal and urinary disorders |
|
| Hematological | Blood and lymphatic system disorders |
|
| Hematoma requiring drainage | Blood and lymphatic system disorders |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders |
|
| Operative Adverse Event (fracture of femur | Surgical and medical procedures |
|
| Operative Adverse Event (other complication | Surgical and medical procedures |
|
| Operative Adverse Event (seating acetabular prosthesis) | Surgical and medical procedures |
|
| Peripheral nervous system | Nervous system disorders |
|
| Respiratory system | Respiratory, thoracic and mediastinal disorders |
|
| Deep Infection | Infections and infestations |
|
| Central Nervous System | Nervous system disorders |
|
| Genitourinary | Renal and urinary disorders |
|
| Respiratory system | Respiratory, thoracic and mediastinal disorders |
|
| Dermatological | Skin and subcutaneous tissue disorders |
|
| Hematological | Blood and lymphatic system disorders |
|
| Cardiovascular | Cardiac disorders |
|
| Gastrointestinal | Gastrointestinal disorders |
|
| Constitutional symptom | General disorders |
|
| Wound problem | Injury, poisoning and procedural complications |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders |
|
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| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |