Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059017) titled 'Intraoperative Fluoroscopic Evaluation of Stem Anteversion in Total Hip Arthroplasty' on Oct. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Niigata University

Condition: Condition - Osteoarthritis of the hip and osteonecrosis of the femoral head Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study was to investigate whether the use of intraoperative fluoroscopy, aligned with the transverse axis of the stem, could improve the accuracy of implantation by reducing discrepancies from the preoperative plan. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The stem is aligned with the axis under intraoperative fluoroscopy, and its implantation is performed after confirming that the appearances of the greater and lesser trochanters are comparable to the preoperative plan and within the acceptable range Interventions/Control_2 - Absence of fluoroscopic guidance for determining intraoperative stem anteversion.

Eligibility: Age-lower limit - 30 years-old

Gender - Male and Female Key inclusion criteria - Cases of total hip arthroplasty performed at Niigata University Medical and Dental Hospital and Tsubokawa General Hospital after approval by the institutional review boards and before July 31, 2027. Key exclusion criteria - Exclusion criteria were as follows:

Use of a cemented stem

Intraoperative fracture

Patients who refused participation in the study or survey Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 01 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067496

Disclaimer: Curated by HT Syndication.