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

NCT07318194 | Active Not Recruiting

• 1 other identifier: 01-23-105-045
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Distal Radius Fracture

Keywords

Ischaemia; Arterial Occlusion Pressure; Limb Occlusion Pressure; Surgical field; Distal radius fracture

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (10)

• FRACTURE TYPE

  Preoperative

• SYSTOLIC BLOOD PRESSURE

  Measured inside the operating room, after the patient has been lightly sedated.

• PRWE TEST

  Assessed one year postoperatively

• QUICK-DASH TEST

  Assessed one year postoperatively

• RANGE OF MOVEMENT

  Assessed one year postoperatively

Study Arms (2)

PNEUMATIC TOURNIQUET USING LIMB OCCLUSION PRESSURE

EXPERIMENTAL

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

PNEUMATIC TOURNIQUET USING ARTERIAL OCCLUSION PRESSURE

ACTIVE COMPARATOR

Pneumatic cuff pressure is calculated by adding 100 mmHg to the patient's systolic blood pressure.

Procedure: PNEUMATIC TOURNIQUET INFLATION PRESSURE

Interventions

PNEUMATIC TOURNIQUET INFLATION PRESSURE PROCEDURE

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.

PNEUMATIC TOURNIQUET USING ARTERIAL OCCLUSION PRESSURE; PNEUMATIC TOURNIQUET USING LIMB OCCLUSION PRESSURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead

Study Sites (1)

JM Mora, Terrassa, Barcelona, 08227

Terrassa, Barcelona, 08227, Spain

Location

MeSH Terms

Conditions

Wrist Fractures; Ischemia

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. Chief of Shoulder Unit

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: June 6, 2023
• Primary Completion: October 15, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-05

Locations

ES (1)