Radiographic Migration Analysis of the Insignia Hip Stem

The purpose of this study is to assess the migration pattern of the Insignia hip stem using radiostereometric analysis (RSA for short) and computed tomography (CT). Only patients with degenerative joint disease requiring primary total hip replacement will be asked to participate. The other purpose is to assess if there are any differences between the gold-standard RSA-measured migration and CT-RSA-measured migration. The clinical outcomes will be measured using joint function and patient satisfaction questionnaires. Approximately thirty patients will be enrolled onto the study.

Study Overview

• Status: Active, not recruiting
• Conditions: Hip Implant; Hip Replacement in Osteoarthritis Patients; Migration of Implant
• Intervention / Treatment: Device: Insignia

Detailed Description

This is a single-centre, non-randomized, non-controlled trial of patients undergoing primary total hip arthroplasty using the Insignia hip stem. Patients will undergo RSA and CT-RSA imaging and analyses to identify migration of the femoral stem with respect to the adjuvant bone during the first 2 post-operative years.

The primary outcome of this study is to determine if femoral stem stability is achieved between 6-12 month and 12-24 month post-operative intervals.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 2M9
      • Concordia Hip & Knee Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty - Aged 21 years or older
• Patients willing and able to comply with follow-up requirements and self-evaluations
• Ability to give informed consent

Exclusion Criteria:

• Active or prior infection
• Medical condition precluding major surgery
• Medical condition with less than 2 years life expectancy
• Overhanging pannus (direct anterior approach)
• Prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal)
• Skin condition on the area of incision
• Multi-level lumbar spine fusion
• Ankylosing spondylolithesis
• Shortening osteotomy through the femur

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Insignia; Total hip replacement CT-RSA vs gold standard RSA	Device: Insignia; Insignia hip stem; Trident hemispherical shell; X3 polyethylene liner; Metal or ceramic head

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migration	Quantify migration of the Insignia stem using RSA and CT-RSA	Up to 2 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early migration	Quantify early migration of the Trident acetabular cup using RSA	Up to 2 years post-operative
Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year	The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living	Up to 2 years post-operative
Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year	The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.	Up to 2 years post-operative
Changes in Patient Satisfaction (VAS) from baseline(pre-op) to 6-month, 1-year and 2-year	Evaluate and compare the change from preoperative to 2 years in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (Unsatified) - 100 (Completely Satisfied).	Up to 2 years post-operative
Validation	Comparison of RSA and CT-RSA using the standard deviation of the mean component migration calculated from examinations.	Up to 2 years post-operative

Collaborators and Investigators

• Sponsor: Canadian Radiostereometric Analysis Network
• Collaborators: Orthopaedic Innovation Centre
• Investigators: Principal Investigator: Eric R Bohm, MD, Orthopaedic Innovation Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: RSA; Total hip replacement; Insignia
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: B2024:118

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.: Yes