Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| PNEUMATIC TOURNIQUET USING ARTERIAL OCCLUSION PRESSURE | Active Comparator | Pneumatic cuff pressure is calculated by adding 100 mmHg to the patient's systolic blood pressure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JM Mora, Terrassa, Barcelona, 08227 | Terrassa | Barcelona | 08227 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Measured inside the operating room immediately prior to the start of surgery. |
| 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. |
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided