Surgical Field Quality Assessment and Complications in Distal Radius Fractures Using the Minimum Inflation Tourniquet Pressure.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Procedure: PNEUMATIC TOURNIQUET INFLATION PRESSURE

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Terrassa, Barcelona, Spain, 08227
      • JM Mora, Terrassa, Barcelona, 08227

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 years or older, diagnosed with a distal radius fracture meeting surgical criteria.
• Surgery performed by the Hand Unit at Terrassa University Hospital.
• Axillary block as the anaesthetic technique.
• The surgeon completes all required study procedures.
• Written informed consent obtained from the patient.

Exclusion Criteria:

• Bilateral distal radius fractures.
• Osteosynthesis of an ipsilateral distal ulnar fracture.
• Requirement for general anaesthesia.
• High anaesthetic risk (ASA IV).
• Body mass index (BMI) > 40.
• Uncontrolled hypertension or treatment with more than three antihypertensive medications.
• Contraindications to tourniquet use, such as arteriovenous fistulas or peripheral vascular disease.
• Failure of the surgeon to complete the required study procedures.
• Lack of informed consent for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PNEUMATIC TOURNIQUET USING LIMB OCCLUSION PRESSURE; A distal sensor connected to the pneumatic tourniquet system is placed on the patient's index finger and automatically calculates the minimum ischaemia pressure required to occlude the distal blood flow.	Procedure: PNEUMATIC TOURNIQUET INFLATION PRESSURE; Patients undergoing osteosynthesis of distal radius fractures will be randomised in two groups: pneumatic cuff pressure calculated based on Limb Occlusion Pressure, and pneumatic cuff pressure calculated based on Arterial Occlusion Pressure, without adding any security margin in any group.
Active Comparator: PNEUMATIC TOURNIQUET USING ARTERIAL OCCLUSION PRESSURE; Pneumatic cuff pressure is calculated by adding 100 mmHg to the patient's systolic blood pressure.	Procedure: PNEUMATIC TOURNIQUET INFLATION PRESSURE; Patients undergoing osteosynthesis of distal radius fractures will be randomised in two groups: pneumatic cuff pressure calculated based on Limb Occlusion Pressure, and pneumatic cuff pressure calculated based on Arterial Occlusion Pressure, without adding any security margin in any group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SURGICAL FIELD BLEEDING	Fromme scale (0-5). Assessed by the main surgeon. 0 (the best) - 5 (the worst)	At the end of the surgery.
ISCHAEMIA TIME	Measured in minutes. It refers to the duration from the onset of pneumatic ischemia until its cessation, prior to wound closure at the end of the surgery.	Measured at the end of the surgery.
INTRAOPERATORY PAIN	Pain caused by the pneumatic cuff on the arm, measured using the Visual Analogue Scale (0-10). 0 (the best) - 10 (the worst)	Measured 60 minutes after the start of the surgery.
COMPLICATIONS	Any cutaneous, muscular, vascular or nervous complication.	During the surgery or the immediate postoperative period.
MUSCLE DAMAGE	Assessed based on creatine kinase (CK) levels. Expressed in μmol/L.	In postoperative blood tests 60 minutes after surgery.
LIMB OCCLUSION PRESSURE	Measured in mmHg. Automatically recorded by placing a distal sensor on the index finger (second digit) of the hand, connected to the pneumatic ischemia device. No safety margin will be applied. A single measurement will be taken.	Measured inside the operating room immediately prior to the start of surgery.
ARTERIAL OCCLUSION PRESSURE	Expressed in mmHg. Calculated using the formula: systolic blood pressure + 100 mmHg.	Measured inside the operating room immediately prior to the start of surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FRACTURE TYPE	Measured in the wrist X-Ray using Frykman Scale (1-8).	Preoperative
SYSTOLIC BLOOD PRESSURE	Expressed in mmHg. Measured in the limb to be treated.	Measured inside the operating room, after the patient has been lightly sedated.
PRWE TEST	15-item questionnaire scoring pain and function (0-100 scale, 0=best/no problem, 100=worst)	Assessed one year postoperatively
QUICK-DASH TEST	functionality scale. calculating a score from 0-100 where higher means more difficulty/worse function	Assessed one year postoperatively
RANGE OF MOVEMENT	In degrees. Using a goniometer. Wrist flexion, extension, radial deviation, ulnar deviation, pronation supination.	Assessed one year postoperatively
GRIP STRENGTH	Expressed in kg. Using a dynamometer.	Assessed one year postoperatively.
EUROQOL-5D TEST	Quality of life scale. The EQ-5D (EuroQol 5-Dimension) is a widely used questionnaire assessing health-related quality of life through five dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression, each rated on a scale (3 or 5 levels).	Assessed one year postoperatively.
SF-12 TEST	Quality of life scale. Scores above 50 indicate a better-than-average health-related quality of life. Scores below 50 suggest below-average health	Assessed one year postoperatively.
BODY MASS INDEX	Calculated according to weight (in kg) and height (in centimeters).	Preoperative
ARM CIRCUMFERENCE	Expressed in centimeters. Measured with a tape measure.	Preoperative.

Collaborators and Investigators

• Sponsor: Consorci Sanitari de Terrassa

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Actual): October 15, 2025
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Distal radius fracture; Ischaemia; Arterial Occlusion Pressure; Limb Occlusion Pressure; Surgical field
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Fractures, Bone; Arm Injuries; Wrist Injuries; Pathological Conditions, Signs and Symptoms; Wrist Fractures; Ischemia
• Other Study ID Numbers: 01-23-105-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No