Skip to content

Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study

Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06379555
Acronym
WALANPOIGNE
Enrollment
12
Registered
2024-04-23
Start date
2024-11-06
Completion date
2027-06-30
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wrist Fractures

Brief 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

Detailed 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

Interventions

PROCEDUREWalanpoigne

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

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Failure percentageDay 1A 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

Secondary

MeasureTime frameDescription
Pain assessmentDay 1, 7 and 30Pain 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.
Patient experienceDay 1Patient 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.
Wrist mobilityDay 7 and 30Wrist mobility will be assessed with flexion/extension and pronosupination (measured in degrees with the goniometer)
Functional characteristics of the wristDay 7 and 30Functional 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.
ComplicationsDay 1 to Day 30Complications will be assessed with collection of adverse events, particularly intraoperative bleeding

Countries

France

Contacts

Primary ContactThomas APARD, MD
thomasapard@echo-chirurgie-versailles.fr+33 6 81 61 05 80

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026