NCT01756820

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

December 20, 2012

Last Update Submit

May 10, 2016

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrometransverse ligamentcarpal tunnel releaseendoscopicminimal invasivemini-openmedian nerve

Outcome Measures

Primary Outcomes (2)

  • Overall Satisfaction

    Satisfaction will be assessed by two ways * by answering to the question "are you happy with the result of the surgery?" * with a VAS score (0-100) assessing the satisfaction

    at 1 and 6 months postoperatively

  • Complications

    Any complication will be reported including remaining numbness, pain in incision, painful scar, complex regional pain syndrome, infection etc

    up to 6 months postoperatively

Secondary Outcomes (7)

  • Pain

    at 1 and 6 months postoperatively

  • Grip strength

    at 1 and 6 months postoperatively

  • key pinch

    at 1 and 6 months postoperatively

  • Time to return to Activities of Daily Living (ADL) and return to work

    up to the end of the study

  • Recurrences and reoperations

    up to the end of study

  • +2 more secondary outcomes

Study Arms (2)

Single-portal Endoscopic Carpal Tunnel Release (Microaire®)

ACTIVE COMPARATOR

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

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

Knifelight®

ACTIVE COMPARATOR

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

Procedure: Knifelight

Interventions

Single-portal Endoscopic Carpal Tunnel Release (Microaire®)PROCEDURE

SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire (http://www.microaire.com/products/ectr-endoscopic-carpal-tunnel/smart-release-ctrs/).

Also known as: SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire.
Single-portal Endoscopic Carpal Tunnel Release (Microaire®)
KnifelightPROCEDURE

A mini-open single portal technique using the Knifelight® device (Stryker) according to the surgical technique as described by the manufacturer (antegrade approach)

Also known as: Knifelight®, Stryker
Knifelight®

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary Carpal Tunnel Syndrome
  • no symptoms' relief after 3 months of conservative treatment (NSAIDS, Cast, rest)
  • electrophysiological examination confirms the Carpal Tunnel Syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Ioannina

Ioannina, 45500, Greece

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Haris S Vasiliadis, MD, PhD

    Department of Orthopaedics, School of Medicine, University of Ioannina, Greece

    PRINCIPAL INVESTIGATOR

  • Theodoros Xenakis

    Department of Orthopaedics, School of Medicine, University of Ioannina, Greece

    STUDY CHAIR

  • Grigorios Mitsionis

    Department of Orthopaedics, School of Medicine, University of Ioannina, Greece

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Orthopaedics

Study Record Dates

First Submitted

December 20, 2012

First Posted

December 27, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations

GR(1)