Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Walanpoigne

    Procedure/Surgery

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

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: WalanpoigneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 1

Secondary outcomes

1

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.

Time frame
Day 1, 7 and 30
2

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.

Time frame
Day 1
3

Wrist mobility

Wrist mobility will be assessed with flexion/extension and pronosupination (measured in degrees with the goniometer)

Time frame
Day 7 and 30
4

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.

Time frame
Day 7 and 30

Other outcomes

Sponsors and contacts

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