Clinical trial NCT06696313: Radiographic Migration Analysis of the Insignia Hip Stem
Official title: Radiographic Migration Analysis of the Insignia Hip Stem
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Implant
Hip Replacement in Osteoarthritis Patients
Migration of Implant
Keywords: Insignia
RSA
Total hip replacement
Lead sponsor: Canadian Radiostereometric Analysis Network
Sponsor class: OTHER
Collaborators: name: Orthopaedic Innovation Centre
First posted: 2024-11-20
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Migration
timeFrame: Up to 2 years post-operative
Secondary outcomes:
measure: Validation
timeFrame: Up to 2 years post-operative
measure: Early migration
timeFrame: Up to 2 years post-operative
measure: Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year
timeFrame: Up to 2 years post-operative
measure: Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year
timeFrame: Up to 2 years post-operative
measure: Changes in Patient Satisfaction (VAS) from baseline(pre-op) to 6-month, 1-year and 2-year
timeFrame: Up to 2 years post-operative
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Concordia Hip & Knee Institute
state: Manitoba
Study officials:
affiliation: Orthopaedic Innovation Centre
name: Eric R Bohm, MD
role: PRINCIPAL_INVESTIGATOR
References: