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

Carpal Tunnel Syndrome Clinical Trial

— CTR  

Official title:

Carpal Tunnel Release With Partial Excision of the Flexor Retinaculum Through Two Small Incisions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500355
• Other study ID #: qhd20150712
• Status: Completed
• Phase: N/A
• First received: July 12, 2015
• Last updated: July 15, 2015
• Start date: January 2010
• Est. completion date: February 2013

Study information

• Verified date: July 2015
• Source: The Second Hospital of Qinhuangdao
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Hubei Province
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 68 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Procedure:
• Carpal Tunnel Release via limited approaches
Carpal tunnel release with partial excision of the flexor retinaculum via two small incisions.
• Carpal Tunnel Release via standard approach
Carpal tunnel release with partial excision of the flexor retinaculum via the standard incision.
• Endoscopic Carpal Tunnel Release
Carpal tunnel release under endoscope.

Device:
• endoscope or an arthroscopic device

Locations

Country	Name	City	State
China	The second hospital of Qinhuangdao	Qinhuangdao	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Qinhuangdao

Country where clinical trial is conducted

China, 

References & Publications (2)

Aksekili MA, Biçici V, Isik Ç, 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of symptoms and functional status on Boston Questionnaire		2 years	Yes
Secondary	Grip strength		2 years	Yes