Distal Radius FractureNCT07318194
Surgical Field Quality Assessment and Complications in Distal Radius Fractures Using the Minimum Inflation Tourniquet Pressure.
A study testing PNEUMATIC TOURNIQUET INFLATION PRESSURE in people with Distal Radius Fracture, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- PNEUMATIC TOURNIQUET INFLATION PRESSURE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 6 Jun 2023to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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.
- Conditions
- Distal Radius Fracture
- Being tested
- PNEUMATIC TOURNIQUET INFLATION PRESSURE
- Keywords
- Ischaemia, Arterial Occlusion Pressure, Limb Occlusion Pressure, Surgical field, Distal radius fracture
- Medical subject headings
- Wrist Fractures, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNEUMATIC TOURNIQUET INFLATION PRESSUREProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: PNEUMATIC TOURNIQUET INFLATION PRESSURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
SURGICAL FIELD BLEEDING
Fromme scale (0-5). Assessed by the main surgeon. 0 (the best) - 5 (the worst)
Measured: 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: 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: Measured 60 minutes after the start of the surgery.
COMPLICATIONS
Any cutaneous, muscular, vascular or nervous complication.
Measured: During the surgery or the immediate postoperative period.
MUSCLE DAMAGE
Assessed based on creatine kinase (CK) levels. Expressed in μmol/L.
Measured: 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: 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: Measured inside the operating room immediately prior to the start of surgery.
Secondary outcomes (10)
FRACTURE TYPE
Measured in the wrist X-Ray using Frykman Scale (1-8).
Measured: Preoperative
SYSTOLIC BLOOD PRESSURE
Expressed in mmHg. Measured in the limb to be treated.
Measured: 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)
Measured: Assessed one year postoperatively
QUICK-DASH TEST
functionality scale. calculating a score from 0-100 where higher means more difficulty/worse function
Measured: Assessed one year postoperatively
RANGE OF MOVEMENT
In degrees. Using a goniometer. Wrist flexion, extension, radial deviation, ulnar deviation, pronation supination.
Measured: Assessed one year postoperatively
GRIP STRENGTH
Expressed in kg. Using a dynamometer.
Measured: 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).
Measured: 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
Measured: Assessed one year postoperatively.
BODY MASS INDEX
Calculated according to weight (in kg) and height (in centimeters).
Measured: Preoperative
ARM CIRCUMFERENCE
Expressed in centimeters. Measured with a tape measure.
Measured: Preoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start6 Jun 2023
- Primary completion15 Oct 2025
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Maria Mora Guix, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318194
- Sponsor's protocol ID
- 01-23-105-045
- Status last verified
- May 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07318194
- Acronym / sponsor ID
- 01-23-105-045
- Conditions
- Distal Radius Fracture
- Keywords
- Ischaemia, Arterial Occlusion Pressure, Limb Occlusion Pressure, Surgical field, Distal radius fracture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNEUMATIC TOURNIQUET USING LIMB OCCLUSION PRESSURE | Experimental | Procedure: PNEUMATIC TOURNIQUET INFLATION PRESSUREA 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 | Procedure: PNEUMATIC TOURNIQUET INFLATION PRESSUREPneumatic cuff pressure is calculated by adding 100 mmHg to the patient's systolic blood pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNEUMATIC TOURNIQUET INFLATION PRESSUREPatients 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. | Procedure or surgery | PNEUMATIC TOURNIQUET USING ARTERIAL OCCLUSION PRESSURE, PNEUMATIC TOURNIQUET USING LIMB OCCLUSION PRESSURE |
Primary outcome
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)
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.
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)
COMPLICATIONS
Time frame: During the surgery or the immediate postoperative period.
Any cutaneous, muscular, vascular or nervous complication.
MUSCLE DAMAGE
Time frame: In postoperative blood tests 60 minutes after surgery.
Assessed based on creatine kinase (CK) levels. Expressed in μmol/L.
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.
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.
10 secondary outcomes
FRACTURE TYPE
Time frame: Preoperative
SYSTOLIC BLOOD PRESSURE
Time frame: Measured inside the operating room, after the patient has been lightly sedated.
PRWE TEST
Time frame: Assessed one year postoperatively
QUICK-DASH TEST
Time frame: Assessed one year postoperatively
RANGE OF MOVEMENT
Time frame: Assessed one year postoperatively
GRIP STRENGTH
Time frame: Assessed one year postoperatively.
EUROQOL-5D TEST
Time frame: Assessed one year postoperatively.
SF-12 TEST
Time frame: Assessed one year postoperatively.
BODY MASS INDEX
Time frame: Preoperative
ARM CIRCUMFERENCE
Time frame: Preoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNEUMATIC TOURNIQUET INFLATION PRESSURE in people with Distal Radius Fracture, run by Consorci Sanitari de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SURGICAL FIELD BLEEDING (time frame: At the end of the surgery.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.