Surgical Field Quality Assessment and Complications in Distal Radius Fractures Using the Minimum … (NCT07318194) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Surgical Field Quality Assessment and Complications in Distal Radius Fractures Using the Minimum Inflation Tourniquet Pressure.
Spain140 participantsStarted 2023-06-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SURGICAL FIELD BLEEDING
Timeframe: At the end of the surgery.
2
ISCHAEMIA TIME
Timeframe: Measured at the end of the surgery.
3
INTRAOPERATORY PAIN
Timeframe: Measured 60 minutes after the start of the surgery.
4
COMPLICATIONS
Timeframe: During the surgery or the immediate postoperative period.
5
MUSCLE DAMAGE
Timeframe: In postoperative blood tests 60 minutes after surgery.
6
LIMB OCCLUSION PRESSURE
Timeframe: Measured inside the operating room immediately prior to the start of surgery.
7
ARTERIAL OCCLUSION PRESSURE
Timeframe: Measured inside the operating room immediately prior to the start of surgery.