osteoarthritis of the hip
Conditions
Interventions
The Insignia Stem utilizes a tapered wedge geometry for fixation within the proximal femur. A key design feature is its substantial proximal volume aimed at maximizing metaphyseal fill in lateral view
Sponsors
Ehime University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Undergoing primary unilateral or bilateral (simultaneous or staged) Total Hip Arthroplasty (THA) at Ehime University Hospital. 2) Diagnosis of advanced to end-stage osteoarthritis of the hip, confirmed radiographically. 3) Presence of hip pain causing functional limitations in activities of daily living (ADLs). 4) Suitable candidacy for either the Insignia Stem or the Accolade II Stem, confirmed by pre-operative CT-based 3D templating. 5) Ability and willingness to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients unable to achieve outdoor ambulation, even with the assistance of walking aids (e.g., canes, walkers). 2) Patients with cognitive impairment precluding informed consent, or those otherwise unable to express intention to participate; additionally, any patient deemed unsuitable for study inclusion by the principal investigator or sub-investigators. 3) Patients diagnosed with osteoarthritis of the hip secondary to infection or trauma, idiopathic osteonecrosis of the femoral head (ONFH), or high-grade developmental dysplasia of the hip (Crowe type III or IV). 4) Patients assessed by the attending physician, based on pre-operative CT planning, as having poor suitability for femoral implant fixation due to anatomical or bone quality concerns.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the change in periprosthetic bone mineral density, measured quantitatively at 1, 2, and 5 years postoperatively using bone mineral density testing around the stem. This change will be calculated relative to the bone mineral density around the stem measured on the 7th day after THA surgery, and the effect of differences in stem design on these changes in periprosthetic bone mineral density will be compared between the two groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will compare the two groups regarding the impact of stem design differences on radiological evaluations (plain radiographs and CT scans) and on pre- and post-operative clinical evaluations, including muscle strength, patient-reported outcomes, activity level, and other relevant factors. | — |
Countries
Japan
Contacts
Public ContactTatsuhiko Kutsuna
Ehime University Graduate School of Medicine Department of Orthopaedic Surgery
Outcome results
None listed