Survival of the Insignia Stem in Total Hip Arthroplasty

NCT ID: NCT05313321

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-17
• Study Completion Date: 2028-03-31

Brief 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.

Detailed Description

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.

Conditions

Primary Total Hip Arthroplasty

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Primary total hip arthroplasty receiving the Insignia Stem

Intervention Type: DEVICE

Patients receiving the Insignia Stem and associated Stryker Acetabular Component for total hip arthroplasty

Interventions

Primary total hip arthroplasty receiving the Insignia Stem

Patients receiving the Insignia Stem and associated Stryker Acetabular Component for total hip arthroplasty

Intervention Type: DEVICE

Other Intervention Names

Total Hip Arthroplasty

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Lucas Anderson

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucas Anderson, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah Orthopaedics

Locations

University of Utah Orthopaedic Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

145076

Identifier Type: -

Identifier Source: org_study_id