University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108, United States
NCT Number: NCT05313321
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–100 year
All sexes
Observational
Salt Lake City, Utah, 84108, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients receiving the Insignia Stem and associated Stryker Acetabular Component for total hip arthroplasty
Other names: Total Hip Arthroplasty
Time frame: Pre-operative
Reviewing radiographic radiolucent lines <2mm
Time frame: 6-weeks post-operative
Reviewing radiographic radiolucent lines <2mm
Time frame: 1-year post-operative
Reviewing radiographic radiolucent lines <2mm
Time frame: 2-years post-operative
Reviewing radiographic radiolucent lines <2mm
University of Utah
Other
Mid-term Survival of the Insignia Stem in Primary Total Hip Arthroplasty
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