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The investigators primary objective of this study is to evaluate radiographic fit and fill of the Insignia stem and identify risk factors for aseptic failure. The investigators hypotheses being tested is: the newly designed Insignia stem demonstrates acceptable radiographic fit and fill by reviewing radiolucent lines <2mm.
Total hip arthroplasty is one of the most functionally restorative procedures in modern medicine. Since its introduction in the mid twentieth century significant advancements in implant materials have occurred. There is debate on the design of the femoral stem in total hip arthroplasty. The use of uncemented, Hydroxyapatite (HA)-coated femoral stems have been shown to be reliable and are commonly used. One such implant is the Insigniaâ„¢ Hip Stem (Stryker, Kalamazoo, MI, USA).
The Insigniaâ„¢ Hip Stem is a collared stem that features a plasma-sprayed Hydroxyapatite (HA) coating over plasma-sprayed titanium in the proximal region and a plasma-sprayed HA coating over grit blast in the distal region and collar underside. Unfortunately, with it's novelty comes a lack of clinical follow-up and evaluation. As such, the investigators purpose of this study is to evaluate the early radiographic of the Insigniaâ„¢ Hip Stem.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary total hip arthroplasty receiving the Insignia Stem | Patients undergoing primary total hip arthroplasty that will likely receive the Insignia Stem and associated Stryker Acetabular Component. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary total hip arthroplasty receiving the Insignia Stem | Device | Patients receiving the Insignia Stem and associated Stryker Acetabular Component for total hip arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographs review | Reviewing radiographic radiolucent lines <2mm | Pre-operative |
| Radiographs review | Reviewing radiographic radiolucent lines <2mm | 6-weeks post-operative |
| Radiographs review | Reviewing radiographic radiolucent lines <2mm | 1-year post-operative |
| Radiographs review | Reviewing radiographic radiolucent lines <2mm | 2-years post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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Patients planning on undergoing primary total hip arthroplasty
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| Name | Affiliation | Role |
|---|---|---|
| Lucas Anderson, M.D. | University of Utah Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Orthopaedic Center | Salt Lake City | Utah | 84108 | United States |
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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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|
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |