Clinical trial NCT02500355: Carpal Tunnel Release Via Two Small Incisions Comparing With Via Standard Incision And Under Endoscope
Official title: Carpal Tunnel Release With Partial Excision of the Flexor Retinaculum Through Two Small Incisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: The Second Hospital of Qinhuangdao
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Severity of symptoms and functional status on Boston Questionnaire
timeFrame: 2 years
Secondary outcomes:
measure: Grip strength
timeFrame: 2 years
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: The second hospital of Qinhuangdao
state: Hebei
Study officials:
affiliation: The Second Hospital of Qinhunangdao
name: Xu Zhang, MD
role: STUDY_CHAIR
References:
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.
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.