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Completed

NCT Number: NCT02500355

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

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

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Key information

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The second hospital of Qinhuangdao

Qinhuangdao, Hebei, 066600, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carpal Tunnel Release via limited approaches

Procedure

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

Carpal Tunnel Release via standard approach

Procedure

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

endoscopic carpal tunnel release

Procedure

Carpal tunnel release under endoscope.

endoscope or an arthroscopic device

Device

Primary outcomes

  1. Severity of symptoms and functional status on Boston Questionnaire

    Time frame: 2 years

Secondary outcomes

  1. Grip strength

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

The Second Hospital of Qinhuangdao

Other

Registry information

Official study title

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

Acronym: CTR

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 16, 2015
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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