Tokyo, Sept. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059085) titled 'Evaluation of the Effectiveness of Early Postoperative Orthotic Therapy for Elbow Fractures' on Sept. 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Gifu Prefectural General Medical Center

Condition: Condition - Elbow fractures Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of the use of orthoses and the type of orthoses in the early postoperative period for patients with elbow fractures. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Standard rehabilitation is performed from 2 to 6 weeks post-surgery. Use the elbow extension orthosis only at night. Interventions/Control_2 - In addition to standard rehabilitation, using a dynamic elbow flexion orthosis from 2 to 6 weeks post-surgery (30 minutes, 3 times a day). Use the elbow extension orthosis at night.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1)Adequate fracture and/or ligamentous stability for use of mobilizing orthosis as determined by the surgeon. 2)Patients who were able to continue rehabilitation up to 6 weeks postoperatively. 3)Patients capable of operating orthotic devices independently. Key exclusion criteria - 1)Active infections or wound-healing issues 2)Heterotopic ossifications 3)Any neurlogical conditions 4)Burns-related contractures 5)Total elbow replacement 6)Patients with cognitive impairments Target Size - 75

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2024 Year 07 Month 23 Day Date of IRB - 2024 Year 09 Month 10 Day Anticipated trial start date - 2024 Year 09 Month 10 Day Last follow-up date - 2028 Year 01 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067576

Disclaimer: Curated by HT Syndication.