Clinical trial NCT06379555: Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study
Official title: Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wrist Fractures
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Failure percentage
timeFrame: Day 1
Secondary outcomes:
measure: Pain assessment
timeFrame: Day 1, 7 and 30
measure: Patient experience
timeFrame: Day 1
measure: Wrist mobility
timeFrame: Day 7 and 30
measure: Functional characteristics of the wrist
timeFrame: Day 7 and 30
measure: Functional characteristics of the wrist
timeFrame: Day 7 and 30
measure: Complications
timeFrame: Day 1 to Day 30
Other outcomes:
Locations:
Study officials:
References: