Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07318194

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JM Mora, Terrassa, Barcelona, 08227

Terrassa, Barcelona, 08227, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. SURGICAL FIELD BLEEDING

    Time frame: At the end of the surgery.

    Fromme scale (0-5). Assessed by the main surgeon. 0 (the best) - 5 (the worst)

  2. ISCHAEMIA TIME

    Time frame: Measured at the end of the surgery.

    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.

  3. INTRAOPERATORY PAIN

    Time frame: Measured 60 minutes after the start of the surgery.

    Pain caused by the pneumatic cuff on the arm, measured using the Visual Analogue Scale (0-10).

    0 (the best) - 10 (the worst)

  4. COMPLICATIONS

    Time frame: During the surgery or the immediate postoperative period.

    Any cutaneous, muscular, vascular or nervous complication.

  5. MUSCLE DAMAGE

    Time frame: In postoperative blood tests 60 minutes after surgery.

    Assessed based on creatine kinase (CK) levels. Expressed in μmol/L.

  6. LIMB OCCLUSION PRESSURE

    Time frame: Measured inside the operating room immediately prior to the start of surgery.

    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.

  7. ARTERIAL OCCLUSION PRESSURE

    Time frame: Measured inside the operating room immediately prior to the start of surgery.

    Expressed in mmHg. Calculated using the formula: systolic blood pressure + 100 mmHg.

Secondary outcomes

  1. FRACTURE TYPE

    Time frame: Preoperative

    Measured in the wrist X-Ray using Frykman Scale (1-8).

  2. SYSTOLIC BLOOD PRESSURE

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

    Expressed in mmHg. Measured in the limb to be treated.

  3. PRWE TEST

    Time frame: Assessed one year postoperatively

    15-item questionnaire scoring pain and function (0-100 scale, 0=best/no problem, 100=worst)

  4. QUICK-DASH TEST

    Time frame: Assessed one year postoperatively

    functionality scale. calculating a score from 0-100 where higher means more difficulty/worse function

  5. RANGE OF MOVEMENT

    Time frame: Assessed one year postoperatively

    In degrees. Using a goniometer. Wrist flexion, extension, radial deviation, ulnar deviation, pronation supination.

  6. GRIP STRENGTH

    Time frame: Assessed one year postoperatively.

    Expressed in kg. Using a dynamometer.

  7. EUROQOL-5D TEST

    Time frame: Assessed one year postoperatively.

    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).

  8. SF-12 TEST

    Time frame: Assessed one year postoperatively.

    Quality of life scale. Scores above 50 indicate a better-than-average health-related quality of life. Scores below 50 suggest below-average health

  9. BODY MASS INDEX

    Time frame: Preoperative

    Calculated according to weight (in kg) and height (in centimeters).

  10. ARM CIRCUMFERENCE

    Time frame: Preoperative.

    Expressed in centimeters. Measured with a tape measure.

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.