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

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

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

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: Carpal Tunnel Release via limited approaches; Procedure: Carpal Tunnel Release via standard approach; Procedure: Endoscopic Carpal Tunnel Release; Device: endoscope or an arthroscopic device

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Qinhuangdao, Hebei, China, 066600
      • The second Hospital of Qinhuangdao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 64 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Carpal Tunnel Release via limited approaches with 2 years follow-up.	Procedure: Carpal Tunnel Release via limited approaches; Carpal tunnel release with partial excision of the flexor retinaculum via two small incisions.
Active Comparator: Group B; Carpal Tunnel Release via standard approach with 2 years follow-up.	Procedure: Carpal Tunnel Release via standard approach; Carpal tunnel release with partial excision of the flexor retinaculum via the standard incision.
Placebo Comparator: Group C; Endoscopic Carpal Tunnel Release with 2 years follow-up.	Procedure: Endoscopic Carpal Tunnel Release; Carpal tunnel release under endoscope.; Device: endoscope or an arthroscopic device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Severity of symptoms and functional status on Boston Questionnaire	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Grip strength	2 years

Collaborators and Investigators

• Sponsor: The Second Hospital of Qinhuangdao
• Investigators: Study Chair: Xu Zhang, MD, The Second Hospital of Qinhunangdao

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 12, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Estimate): July 16, 2015
• Last Update Submitted That Met QC Criteria: July 15, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: qhd20150712