Survival of the Insignia Stem in Total Hip Arthroplasty

NCT05313321 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 145076
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Total Hip Arthroplasty

Keywords

Primary Total Hip Arthroplasty; Insignia™ Hip Stem; Radiographic review

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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.

Device: Primary total hip arthroplasty receiving the Insignia Stem

Interventions

Primary total hip arthroplasty receiving the Insignia Stem DEVICE

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

Also known as: Total Hip Arthroplasty

Primary total hip arthroplasty receiving the Insignia Stem

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients planning on undergoing primary total hip arthroplasty

You may qualify if:

• 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

You may not qualify if:

• Patients with inflammatory or pyogenic arthritis
• Body Mass Index (BMI)\>40
• Bone stock that is inadequate for support or fixation of the prosthesis

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Lucas Anderson, M.D.

  University of Utah Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 6, 2022
• Study Start: March 17, 2022
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)