Viewing Study NCT06379555



Ignite Creation Date: 2024-05-06 @ 8:25 PM
Last Modification Date: 2024-10-26 @ 3:27 PM
Study NCT ID: NCT06379555
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-04-23
First Post: 2024-04-17

Brief Title: Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study
Sponsor: GCS Ramsay Santé pour lEnseignement et la Recherche
Organization: GCS Ramsay Santé pour lEnseignement et la Recherche

Study Overview

Official Title: Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: WALANPOIGNE
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 patients 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None