Status:
COMPLETED
Safety and Efficacy of Percutaneous Carpal Tunnel Release Versus Open Surgery
Lead Sponsor:
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Conditions:
Carpal Tunnel Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Hypothesis: Percutaneous ambulatory carpal tunnel release offers similar outcomes to the open approach in the theatre. Study design: Two-groups randomized single-blind interventional non-inferiority ...
Detailed Description
Background: Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper limb, with a prevalence of around 1'14% and 14'4% of the population. The clinical symptoms are usually ...
Eligibility Criteria
Inclusion
- Over 18 years old.
- Positive electromyography, confirming carpal tunnel syndrome.
- Capable to understand risks and advantages of both procedures.
- Normal blood tests.
Exclusion
- Previous carpal tunnel release in the same hand.
- Previous fracture or dislocation in the area around the forearm, wrist or hand.
- Signs or symptoms of infection.
- Psychiatric disorders.
- Antiplatelet or anticoagulant therapy, that cannot be suspended due to underlying pathology, and does not allow the surgery to be performed.
- Coagulation disorders, or any underlying pathology, with high risk of thrombosis or bleeding.
Key Trial Info
Start Date :
June 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04117516
Start Date
June 5 2019
End Date
November 30 2021
Last Update
March 22 2022
Active Locations (1)
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1
Hospital Arnau de Vilanova/Lliria
Valencia, Spain, 46015