Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study

NCT ID: NCT06379555

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-06
• Study Completion Date: 2027-06-30

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

Conditions

Wrist Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Walanpoigne

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

Group Type: EXPERIMENTAL

Walanpoigne

Intervention Type: PROCEDURE

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

Interventions

Walanpoigne

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Les Franciscaines (Hôpital privé de Versailles)

Versailles, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Thomas APARD, MD

Role: CONTACT

thomasapard@echo-chirurgie-versailles.fr

+33 6 81 61 05 80

Facility Contacts

Thomas APARD, MD

Role: primary

thomasapard@echo-chirurgie-versailles.fr

+ 33 6 81 61 05 80

APARD

Role: backup

Other Identifiers

2023-A02756-39

Identifier Type: -

Identifier Source: org_study_id