Hip Implant, Hip Replacement in Osteoarthritis Patients, Migration of Implant
Conditions
Keywords
Insignia, RSA, Total hip replacement
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.
Interventions
DEVICEInsignia
* Insignia hip stem * Trident hemispherical shell * X3 polyethylene liner * Metal or ceramic head
Sponsors
Orthopaedic Innovation Centre
Canadian Radiostereometric Analysis Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migration | Up to 2 years post-operative | Quantify migration of the Insignia stem using RSA and CT-RSA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early migration | Up to 2 years post-operative | Quantify early migration of the Trident acetabular cup using RSA |
| Validation | Up to 2 years post-operative | Comparison of RSA and CT-RSA using the standard deviation of the mean component migration calculated from examinations. |
| Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year | 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 |
| Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year | 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. |
| Changes in Patient Satisfaction (VAS) from baseline(pre-op) to 6-month, 1-year and 2-year | 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). |
Countries
Canada
Outcome results
None listed