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| Name | Class |
|---|---|
| Orthopaedic Specialty Clinic of Spokane, PLLC | OTHER |
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Sponsor is conducting this post-market study to evaluate the clinical outcome and femoral bone mineral density (BMD) changes associated with the PROFEMUR® PRESERVE hip stem when used as indicated for primary total hip arthroplasty in patients with osteoarthritis of the hip joint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRESERVE total hip arthroplasty implant | Subjects to be prospectively implanted with the PROFEMUR PRESERVE total hip arthroplasty implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total hip arthroplasty implant | Device | PROFEMUR PRESERVE total hip arthroplasty femoral stem |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in bone mineral density (BMD), per dual energy x-ray absorptiometry (DXA) imaging, from standard and custom Gruen zones around the femoral stem. | 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Hip functional outcomes will be assessed using the Harris Hip score. | Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative | |
| Implant loosening will be assessed by the presence of radiographic lucencies around the femoral stem. |
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Inclusion Criteria:
To be included in the study, subjects must meet all of the following criteria:
Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria:
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Subjects will be recruited from the investigator's private orthopedic practice from among patients who require a total hip arthroplasty.
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| Name | Affiliation | Role |
|---|---|---|
| David Scott, MD | Spokane Joint Replacement Center, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spokane Joint Replacement Center | Spokane | Washington | 99218 | United States |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
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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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| 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative |
| Implant survivorship of the femoral stem will be calculated. | 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative |
| Rate of complications will be assessed. | Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative |
| Hip functional outcomes will be assessed using the Forgotten Joint Score. | 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |