Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study

NCT06379555 | Recruiting

• 1 other identifier: 2023-A02756-39
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Wrist Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain assessment

  Day 1, 7 and 30

• Patient experience

  Day 1

• Wrist mobility

  Day 7 and 30

• Functional characteristics of the wrist

  Day 7 and 30

• Functional characteristics of the wrist

  Day 7 and 30

Study Arms (1)

Walanpoigne

EXPERIMENTAL

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

Procedure: Walanpoigne

Interventions

Walanpoigne PROCEDURE

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

Walanpoigne

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Clinique Les Franciscaines (Hôpital privé de Versailles)

Versailles, 78000, France

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Central Study Contacts

Thomas APARD, MD

CONTACT

+33 6 81 61 05 80; thomasapard@echo-chirurgie-versailles.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 23, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)