Tokyo, May 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061295) titled 'Comparison of Two CT-Based Navigation Systems in Total Hip Arthroplasty' on May 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Hyogo Medical University
Condition:
Condition - Osteoarthritis of the hip, osteonecrosis of the femoral head, and femoral neck fracture
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare the implant positioning accuracy between two CT-based navigation systems (Stryker and Nakashima Health Force) in total hip arthroplasty.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Total hip arthroplasty will be performed using the Stryker CT-based navigation system. The navigation system will be used intraoperatively for implant positioning within the standard surgical procedure.
Interventions/Control_2 - Total hip arthroplasty will be performed using the Nakashima Health Force CT-based navigation system. The navigation system will be used intraoperatively for implant positioning within the standard surgical procedure.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients scheduled for primary total hip arthroplasty,
Patients who provide written informed consent
Key exclusion criteria - Revision total hip arthroplasty,
Cemented cup cases,
Patients with prior pelvic osteotomy or pelvic trauma
Target Size - 90
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 01 Day
Date of IRB - 2026 Year 07 Month 01 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2028 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070136
Disclaimer: Curated by HT Syndication.
