Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study

Wrist Fractures Clinical Trial

— WALANPOIGNE  

Official title:

Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379555
• Other study ID #: 2023-A02756-39
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Wrist Fractures

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