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NCT Number: NCT06696313

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concordia Hip & Knee Institute

Winnipeg, Manitoba, R2K 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insignia

Device
  • Insignia hip stem
  • Trident hemispherical shell
  • X3 polyethylene liner
  • Metal or ceramic head

Primary outcomes

  1. Migration

    Time frame: Up to 2 years post-operative

    Quantify migration of the Insignia stem using RSA and CT-RSA

Secondary outcomes

  1. Validation

    Time frame: Up to 2 years post-operative

    Comparison of RSA and CT-RSA using the standard deviation of the mean component migration calculated from examinations.

  2. Early migration

    Time frame: Up to 2 years post-operative

    Quantify early migration of the Trident acetabular cup using RSA

  3. Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year

    Time frame: Up to 2 years post-operative

    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

  4. Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year

    Time frame: Up to 2 years post-operative

    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.

  5. Changes in Patient Satisfaction (VAS) from baseline(pre-op) to 6-month, 1-year and 2-year

    Time frame: Up to 2 years post-operative

    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).

Sponsors and collaborators

Lead sponsor

Canadian Radiostereometric Analysis Network

Other

Collaborators

  • Orthopaedic Innovation Centre

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2024
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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