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Carpal Tunnel Release Via Two Small Incisions Comparing With Via Standard Incision And Under Endoscope (CTR)

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Carpal Tunnel Release via limited approaches
Carpal Tunnel Release via standard approach
Endoscopic Carpal Tunnel Release
endoscope or an arthroscopic device
Sponsored by
The Second Hospital of Qinhuangdao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of CTR was established based on Evidence for Surgical Treatment issued by the British Society for Surgery of the Hand (2003)
  • Patients with moderate, severe, and very severe symptom.

Exclusion Criteria:

  • Mild symptom.
  • Finding had a ganglion based on preoperative ultrasound.
  • Associated with infection, gout, or diabetes.
  • Patients who discontinued intervention and lost to follow-up.

Sites / Locations

  • The second hospital of Qinhuangdao

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Group C

Arm Description

Carpal Tunnel Release via limited approaches with 2 years follow-up.

Carpal Tunnel Release via standard approach with 2 years follow-up.

Endoscopic Carpal Tunnel Release with 2 years follow-up.

Outcomes

Primary Outcome Measures

Severity of symptoms and functional status on Boston Questionnaire

Secondary Outcome Measures

Grip strength

Full Information

First Posted
July 12, 2015
Last Updated
July 15, 2015
Sponsor
The Second Hospital of Qinhuangdao
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1. Study Identification

Unique Protocol Identification Number
NCT02500355
Brief Title
Carpal Tunnel Release Via Two Small Incisions Comparing With Via Standard Incision And Under Endoscope
Acronym
CTR
Official Title
Carpal Tunnel Release With Partial Excision of the Flexor Retinaculum Through Two Small Incisions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Qinhuangdao

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Carpal Tunnel Release via Two Small Incisions Comparing With via Standard Incision And Under Endoscope.
Detailed Description
Carpal tunnel syndrome (CTS) affects over 60 million people worldwide. If a regimen of conservative management has failed, surgical release of the median nerve is warranted. Numerous approaches for carpal tunnel release have been described that range from an open technique to a limited incision to endoscopic release. In addition, partial excision of the flexor retinaculum is advocated by some surgeons because of obtaining better outcomes. However, the procedure is difficult to be accomplished through small incisions owing to poor visualization. Currently, balance of incision, visualization, and partial excision of the flexor retinaculum is still controversial. The objective of this report is to introduce carpal tunnel release with partial excision of the flexor retinaculum through two small incisions. The procedures were performed under lighted head magnifier. This is the first report on the use of our technique. For comparison, the investigators also included two other groups of standard open carpal tunnel release with partial excision of the flexor retinaculum and endoscopic carpal tunnel release without excision of the flexor retinaculum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Carpal Tunnel Release via limited approaches with 2 years follow-up.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Carpal Tunnel Release via standard approach with 2 years follow-up.
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Endoscopic Carpal Tunnel Release with 2 years follow-up.
Intervention Type
Procedure
Intervention Name(s)
Carpal Tunnel Release via limited approaches
Intervention Description
Carpal tunnel release with partial excision of the flexor retinaculum via two small incisions.
Intervention Type
Procedure
Intervention Name(s)
Carpal Tunnel Release via standard approach
Intervention Description
Carpal tunnel release with partial excision of the flexor retinaculum via the standard incision.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Carpal Tunnel Release
Intervention Description
Carpal tunnel release under endoscope.
Intervention Type
Device
Intervention Name(s)
endoscope or an arthroscopic device
Primary Outcome Measure Information:
Title
Severity of symptoms and functional status on Boston Questionnaire
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Grip strength
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of CTR was established based on Evidence for Surgical Treatment issued by the British Society for Surgery of the Hand (2003) Patients with moderate, severe, and very severe symptom. Exclusion Criteria: Mild symptom. Finding had a ganglion based on preoperative ultrasound. Associated with infection, gout, or diabetes. Patients who discontinued intervention and lost to follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Zhang, MD
Organizational Affiliation
The Second Hospital of Qinhunangdao
Official's Role
Study Chair
Facility Information:
Facility Name
The second hospital of Qinhuangdao
City
Qinhuangdao
State/Province
Hebei
ZIP/Postal Code
066600
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25953494
Citation
Notarnicola A, Maccagnano G, Tafuri S, Fiore A, Pesce V, Moretti B. Comparison of shock wave therapy and nutraceutical composed of Echinacea angustifolia, alpha lipoic acid, conjugated linoleic acid and quercetin (perinerv) in patients with carpal tunnel syndrome. Int J Immunopathol Pharmacol. 2015 Jun;28(2):256-62. doi: 10.1177/0394632015584501. Epub 2015 May 7.
Results Reference
background
PubMed Identifier
26131237
Citation
Aksekili MA, Bicici V, Isik C, Aksekili H, Ugurlu M, Dogan M. Comparison of early postoperative period electrophysiological and clinical findings following carpal tunnel syndrome: is EMG necessary? Int J Clin Exp Med. 2015 Apr 15;8(4):6267-71. eCollection 2015.
Results Reference
result

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Carpal Tunnel Release Via Two Small Incisions Comparing With Via Standard Incision And Under Endoscope

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