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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06379555
Other study ID # 2023-A02756-39
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date January 2026

Study information

Verified date April 2024
Source GCS Ramsay Santé pour l'Enseignement et la Recherche
Contact Thomas APARD, MD
Phone +33 6 81 61 05 80
Email thomasapard@echo-chirurgie-versailles.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Wrist articular fractures are more difficult to treat and rehabilitation takes longer. Furthermore, these joint fractures are frequently accompanied by ligament lesions of the carpal bones. For these reasons, it is strongly recommended to check the interior of the wrist joint. This check can be done with wrist arthroscopy. Therefore, fracture reduction can be improved, "step of stairs" can be eliminated under arthroscopic control and ligament rupture of carpal bones can be treated. WALANT anesthesia (Wide Awake Local Anesthesia No Tourniquet) designates a new local anesthesia technique. This technique which allows to maintain the arm or fingers mobility offers several significant advantages: - Greater precision of the surgical procedure. - A reduction in discomfort, risks and related adverse effects to anesthesia. - Faster recovery. WALANT technique is very comfortable for patient and fits perfectly with principles of Enhanced Recovery in Surgery. In this context, this study is based on the hypothesis that it is possible to combine arthroscopy and the WALANT anesthesia technique for reducing wrist fractures


Description:

Wrist fractures are common. Most often, when speaking about wrist fracture, this means distal radius fracture, the radius being one of the two forearm bones and most often affected in cases of fracture. A fracture is articular when the fracture line "goes down" in the joint. These fractures are more difficult to treat and rehabilitation takes longer because it is necessary to ensure that joint surface is perfectly reduced, this means that there are no "stair steps" in the joint. Furthermore, these joint fractures are frequently accompanied by ligament lesions of the carpal bones. For all these reasons, it is strongly recommended to check the interior of the wrist joint. This check can be done with wrist arthroscopy. Arthroscopy not only allows for a complete assessment of lesions but also to treat most of them. Therefore, fracture reduction can be improved, "step of stairs" can be eliminated under arthroscopic control and a ligament rupture of carpal bones can be treated. WALANT anesthesia (Wide Awake Local Anesthesia No Tourniquet) designates a new local anesthesia technique which is based on administration, in association with local anesthetic (lidocaine), of a medicine (epinephrine) which limits bleeding and allows to dispense with a tourniquet. The local anesthetic administration allows to maintain the arm or fingers mobility, while having complete anesthesia. This technique offers several significant advantages: - Greater precision of the surgical procedure. In fact, bleeding limitation and the patient's state of cooperation allow a greater surgical precision. - A reduction in discomfort, risks and related adverse effects to anesthesia. - Faster recovery. WALANT technique is very comfortable for patient and fits perfectly with principles of Enhanced Recovery in Surgery. Several studies have shown that it is possible to reduce distal radius fractures under WALANT anesthesia. As for wrist arthroscopy, this is a classic technique for controlling inside of the wrist joint, allowing not only to have an overall view of wrist injuries but also to treat most of them. In this context, this study is based on the hypothesis that it is possible to combine arthroscopy and the WALANT anesthesia technique for reducing wrist fractures


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patient, male or female, aged = 18 and < 70 years - Patient with a displaced articular fracture of the distal radius (unilateral wrist fracture) - Patient treated on ambulatory way - Patient affiliated to or beneficiary of a social security system - French speaking patient, having signed informed consent Exclusion Criteria: - Patient with previous infection or wrist bone surgery - Patient with multiple fractures or with bilateral wrist fractures - Patient with associated fracture with the wrist fracture - Patient with "pathological" bone - Protected patient: adult under guardianship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision - Patient hospitalized without consent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Walanpoigne
Intervention will combine WALANT anesthesia with arthroscopy to reduce a joint fracture of the wrist

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Outcome

Type Measure Description Time frame Safety issue
Primary Failure percentage A failure is defined by the impossibility of achieving the surgery under WALANT anesthesia. Practically, this translates either to stopping the procedure, either by intra-operative sedation (Protoxide nitrogen, deep hypnosis, general anesthesia) in emergency Day 1
Secondary Pain assessment Pain will be assessed with a VAS (Visual Analogic Scale). Minimum value is 0 and maximum value is 10. 0 means no pain whereas higher scores mean more and more pain. Day 1, 7 and 30
Secondary Patient experience Patient experience will be evaluated using the e-satis questionnaire. Minimum value is 0 and maximum value is 100. 0 means patient is not satisfied whereas higher scores mean patient is more and more satisfied. Day 1
Secondary Wrist mobility Wrist mobility will be assessed with flexion/extension and pronosupination (measured in degrees with the goniometer) Day 7 and 30
Secondary Functional characteristics of the wrist Functional characteristics of the wrist will be assessed with PWRE (Patient-Rated Wrist Evaluation) questionnaire. Each question is rated from 0 to 10. Higher scores mean a worse outcome. Day 7 and 30
Secondary Functional characteristics of the wrist Functional characteristics of the wrist will be assessed with QuickDash questionnaire. Each question is rated from 1 to 5. Higher scores mean a worse outcome. Day 7 and 30
Secondary Complications Complications will be assessed with collection of adverse events, particularly intraoperative bleeding Day 1 to Day 30
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