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Decision of investigational team
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This is a prospective multicenter study. Subjects will be implanted with a Conformis Hip System. If the surgeon intraoperatively decides to use the Cordera femoral stem, these patients will also be enrolled in the study and tracked as a subset of the Conformis Hip System patient population.The study sites will be located in the United States. The study subjects will be followed for 10 years post implantation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conformis Hip System | Device | The Conformis Hip System is an FDA cleared, uncemented, primary total hip replacement device composed of femoral and acetabular components. The system incorporates the use of a pre-operative CT scan to design patient-specific implants and instruments. Using patient imaging (CT scan), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. In addition, each Conformis Hip System device is shipped with an additional (optional) femoral stem (Cordera Femoral Stem). |
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| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | Score 0-100 (successful result = post operative increase in Harris Hip Score of > 20 points + radiographically stable implant + no additional femoral reconstruction; < 70 = poor, 70-79 - fair, 80-89 = good, and 90-100 = excellent) | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Revision rates post-implantation | 10 Years | |
| The Hip Injury and Osteoarthritis Outcome Score (HOOS) | Score 0-100 for each of 5 subscales (symptoms, stiffness, pain, function, and quality of life) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with clinical condition included in the approved Indications For Use for the Conformis Hip System and the Cordera Hip System
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Orthopedic Specialty Center of Northern California | Roseville | California | 95678 | United States | ||
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| 10 Years |
| Incidence of major procedure-related and device-related complications including infection rate | 10 Years |
| Post-operative leg length and implant placement in comparison to preoperative condition | Peri-operative |
| Utilization of fluoroscopy during implantation (number of times utilized; amount of times utilized) | Peri-operative |
| Length of procedure | Peri-operative |
| Length of hospital stay | Peri-operative |
| Blood management (transfusions) | Peri-operative |
| Denver Hip and Knee |
| Parker |
| Colorado |
| 80134 |
| United States |
| Personalized Orthopedic Research Institute | Boynton Beach | Florida | 33437 | United States |
| Orthopaedic Institute of Henderson | Henderson | Nevada | 89052 | United States |
| Tennessee Orthopaedic Alliance | Nashville | Tennessee | 37203 | United States |
| Scott Orthopedic Center | Huntington | West Virginia | 25702 | United States |