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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
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.
JM Mora, Terrassa, Barcelona, 08227
Terrassa, Barcelona, Spain
SURGICAL FIELD BLEEDING
Fromme scale (0-5). Assessed by the main surgeon. 0 (the best) - 5 (the worst)
Time frame: 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.
Time frame: 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)
Time frame: Measured 60 minutes after the start of the surgery.
COMPLICATIONS
Any cutaneous, muscular, vascular or nervous complication.
Time frame: During the surgery or the immediate postoperative period.
MUSCLE DAMAGE
Assessed based on creatine kinase (CK) levels. Expressed in μmol/L.
Time frame: 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.
Time frame: 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.
Time frame: Measured inside the operating room immediately prior to the start of surgery.
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FRACTURE TYPE
Measured in the wrist X-Ray using Frykman Scale (1-8).
Time frame: Preoperative
SYSTOLIC BLOOD PRESSURE
Expressed in mmHg. Measured in the limb to be treated.
Time frame: 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)
Time frame: Assessed one year postoperatively
QUICK-DASH TEST
functionality scale. calculating a score from 0-100 where higher means more difficulty/worse function
Time frame: Assessed one year postoperatively
RANGE OF MOVEMENT
In degrees. Using a goniometer. Wrist flexion, extension, radial deviation, ulnar deviation, pronation supination.
Time frame: Assessed one year postoperatively
GRIP STRENGTH
Expressed in kg. Using a dynamometer.
Time frame: 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).
Time frame: 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
Time frame: Assessed one year postoperatively.
BODY MASS INDEX
Calculated according to weight (in kg) and height (in centimeters).
Time frame: Preoperative
ARM CIRCUMFERENCE
Expressed in centimeters. Measured with a tape measure.
Time frame: Preoperative.