Clinique Les Franciscaines (Hôpital privé de Versailles)
Versailles, 78000, France
Location status: Recruiting
NCT Number: NCT06379555
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
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Versailles, 78000, France
Location status: Recruiting
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:
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention will combine WALANT anesthesia with arthroscopy to reduce a joint fracture of the wrist
Time frame: Day 1
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
Time frame: Day 1, 7 and 30
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.
Time frame: Day 1
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.
Time frame: Day 7 and 30
Wrist mobility will be assessed with flexion/extension and pronosupination (measured in degrees with the goniometer)
Time frame: Day 7 and 30
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.
Time frame: Day 7 and 30
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.
Time frame: Day 1 to Day 30
Complications will be assessed with collection of adverse events, particularly intraoperative bleeding
Contact information is provided by the study sponsor or research team.
GCS Ramsay Santé pour l'Enseignement et la Recherche
Other
Acronym: WALANPOIGNE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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