Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study (WALANPOIGNE)

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

Study Overview

• Status: Recruiting
• Conditions: Wrist Fractures
• Intervention / Treatment: Procedure: Walanpoigne

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

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas APARD, MD; Phone Number: +33 6 81 61 05 80; Email: thomasapard@echo-chirurgie-versailles.fr

Study Locations

• France
  • Versailles, France, 78000
    • Recruiting
    • Clinique Les Franciscaines (Hôpital privé de Versailles)
    • Contact: Thomas APARD, MD; Phone Number: + 33 6 81 61 05 80; Email: thomasapard@echo-chirurgie-versailles.fr
    • Contact: APARD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walanpoigne; This arm will combine WALANT anesthesia WALANT with arthroscopy to reduce a joint fracture of the wrist	Procedure: Walanpoigne; Intervention will combine WALANT anesthesia with arthroscopy to reduce a joint fracture of the wrist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Wrist mobility	Wrist mobility will be assessed with flexion/extension and pronosupination (measured in degrees with the goniometer)	Day 7 and 30
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
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
Complications	Complications will be assessed with collection of adverse events, particularly intraoperative bleeding	Day 1 to Day 30

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries; Wrist Injuries; Wrist Fractures
• Other Study ID Numbers: 2023-A02756-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No