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

NCT02500355 | Completed

• 1 other identifier: qhd20150712
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Severity of symptoms and functional status on Boston Questionnaire

  2 years

Secondary Outcomes (1)

• Grip strength

  2 years

Study Arms (3)

Group A

ACTIVE COMPARATOR

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

Procedure: Carpal Tunnel Release via limited approaches

Group B

ACTIVE COMPARATOR

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

Procedure: Carpal Tunnel Release via standard approach

Group C

PLACEBO COMPARATOR

Endoscopic Carpal Tunnel Release with 2 years follow-up.

Procedure: Endoscopic Carpal Tunnel Release; Device: endoscope or an arthroscopic device

Interventions

Carpal Tunnel Release via limited approaches PROCEDURE

Carpal tunnel release with partial excision of the flexor retinaculum via two small incisions.

Group A

Carpal Tunnel Release via standard approach PROCEDURE

Carpal tunnel release with partial excision of the flexor retinaculum via the standard incision.

Group B

Endoscopic Carpal Tunnel Release PROCEDURE

Carpal tunnel release under endoscope.

Group C

endoscope or an arthroscopic device DEVICE

Group C

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Qinhuangdao: lead

Study Sites (1)

The second hospital of Qinhuangdao

Qinhuangdao, Hebei, 066600, China

Location

Related Publications (2)

• 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.

  PMID: 25953494 BACKGROUND

• 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.

  PMID: 26131237 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Endoscopes

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Officials

• Xu Zhang, MD

  The Second Hospital of Qinhunangdao

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: July 16, 2015
• Study Start: January 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

CN (1)