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Surgical Field Quality Assessment and Complications in Distal Radius Fractures Using the Minimum Inflation Tourniquet Pressure: Limb Occlusion Pressure Versus Arterial Occlusion Pressure. And Clinical, Radiological and Quality of Life Assessment at One-year Follow up. A Randomized Controlled Trial.
Analyse surgical field bleeding, surgical time, and intraoperative pain in patients undergoing osteosynthesis of distal radius fractures using ischaemia pressure calculated based on Limb Occlusion Pressure, compared with Arterial Occlusion Pressure. Additionally, compare muscle damage and postoperative complications, and clinical, functional, quality of life and radiological outcomes at one-year follow-up.
Randomised controlled clinical trial. It will be conducted with patients undergoing osteosynthesis of distal radius fractures (ischaemia pressure calculated according to Arterial Occlusion Pressure or Limb Occlusion Pressure), included consecutively at Terrassa Hospital from June 2023 to October 2025. The estimated sample size will be 70 patients per group. Pneumatic cuff pressure, ischaemia time, intraoperative ischaemia-related pain, surgical field bleeding, muscle damage, and postoperative complications will be assessed. One-year follow-up will include clinical, functional, quality-of-life, and radiological evaluations.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
JM Mora, Terrassa, Barcelona, 08227
Terrassa, Barcelona, Spain
Start Date
June 6, 2023
Primary Completion Date
October 15, 2025
Completion Date
July 30, 2026
Last Updated
January 5, 2026
140
ESTIMATED participants
PNEUMATIC TOURNIQUET INFLATION PRESSURE
PROCEDURE
Lead Sponsor
Consorci Sanitari de Terrassa
NCT05650996
NCT06678438
Data Source & Attribution
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