Single-portal Endoscopic Carpal Tunnel Release Versus Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial (CTS-HV)

University of Ioannina

Status and phase: Withdrawn; Phase 2

Conditions: Carpal Tunnel Syndrome

Treatments: Procedure: Single-portal Endoscopic Carpal Tunnel Release (Microaire®); Procedure: Knifelight

Study type: Interventional

Funder types: Other

Identifiers

NCT01756820

Ioannina-CTS-HV

Details and patient eligibility

About

The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®, Stryker) are equally effective and safe surgical options for the treatment of primary Carpal Tunnel Syndrome.

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary Carpal Tunnel Syndrome

• no symptoms' relief after 3 months of conservative treatment (NSAIDS, Cast, rest)

  • electrophysiological examination confirms the Carpal Tunnel Syndrome

Exclusion criteria

• Secondary Carpal Tunnel Syndrome
• Pregnancy
• Rheumatoid diseases
• Previous trauma at hand or other condition that may effect the anatomy (eg infections)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Single-portal Endoscopic Carpal Tunnel Release (Microaire®)

Active Comparator group

Description:

Single-portal Endoscopic Carpal Tunnel Release (Microaire®) will be used, according to the endoscopic technique described by Agee at al.

Treatment:

Procedure: Single-portal Endoscopic Carpal Tunnel Release (Microaire®)

Knifelight®

Active Comparator group

Description:

A mini-open technique will be performed, using the Knifelight® (Stryker).

Treatment:

Procedure: Knifelight