Survival of the Insignia Stem in Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Insignia™ Hip Stem (Stryker, Kalamazoo, MI, USA). The Insignia™ 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 Insignia™ Hip Stem.

Official Title
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Mid-term Survival of the Insignia Stem in Primary Total Hip Arthroplasty

Conditions
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Primary Total Hip Arthroplasty

Intervention / Treatment
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* Device: Primary total hip arthroplasty receiving the Insignia Stem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age ≥18 Patients planning on undergoing primary total hip arthroplasty that will likely receive the Insignia stem and associated Stryker Acetabular Component. Preoperative diagnosis of osteoarthritis Patients willing and able to comply with follow-up requirements Patients willing to sign an IRB approved consent and authorization document Exclusion Criteria: Patients with inflammatory or pyogenic arthritis Body Mass Index (BMI)>40 Bone stock that is inadequate for support or fixation of the prosthesis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary total hip arthroplasty receiving the Insignia Stem<br>Patients undergoing primary total hip arthroplasty that will likely receive the Insignia Stem and associated Stryker Acetabular Component. | Device: Primary total hip arthroplasty receiving the Insignia Stem<br>* Patients receiving the Insignia Stem and associated Stryker Acetabular Component for total hip arthroplasty<br>* Other names: Total Hip Arthroplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Total Hip Arthroplasty, Insignia™ Hip Stem, Radiographic review