Active — Not RecruitingNot Applicable

Survival of the Insignia Stem in Total Hip Arthroplasty

United States100 participantsStarted 2022-03-17

Plain-language summary

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.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Radiographs review

Timeframe: Pre-operative

Radiographs review

Timeframe: 6-weeks post-operative

Radiographs review

Timeframe: 1-year post-operative

Radiographs review

Timeframe: 2-years post-operative

Trial details

NCT IDNCT05313321

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-03

View on ClinicalTrials.gov More Primary Total Hip Arthroplasty trials