Survival of the Insignia Stem in Total Hip Arthroplasty

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Total Hip Arthroplasty
• Intervention / Treatment: Device: Primary total hip arthroplasty receiving the Insignia Stem

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients planning on undergoing primary total hip arthroplasty

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patients receiving the Insignia Stem and associated Stryker Acetabular Component for total hip arthroplasty; Other Names: Total Hip Arthroplasty

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Lucas Anderson, M.D., University of Utah Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2022
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Primary Total Hip Arthroplasty; Insignia™ Hip Stem; Radiographic review
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement, Hip
• Other Study ID Numbers: 145076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No