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

NCT ID: NCT02500355

Last Updated: 2015-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carpal Tunnel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

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

Group Type ACTIVE_COMPARATOR

Carpal Tunnel Release via limited approaches

Intervention Type PROCEDURE

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

Group B

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

Group Type ACTIVE_COMPARATOR

Carpal Tunnel Release via standard approach

Intervention Type PROCEDURE

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

Group C

Endoscopic Carpal Tunnel Release with 2 years follow-up.

Group Type PLACEBO_COMPARATOR

Endoscopic Carpal Tunnel Release

Intervention Type PROCEDURE

Carpal tunnel release under endoscope.

endoscope or an arthroscopic device

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carpal Tunnel Release via limited approaches

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

Intervention Type PROCEDURE

Carpal Tunnel Release via standard approach

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

Intervention Type PROCEDURE

Endoscopic Carpal Tunnel Release

Carpal tunnel release under endoscope.

Intervention Type PROCEDURE

endoscope or an arthroscopic device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Second Hospital of Qinhuangdao

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xu Zhang, MD

Role: STUDY_CHAIR

The Second Hospital of Qinhunangdao

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The second hospital of Qinhuangdao

Qinhuangdao, Hebei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25953494 (View on PubMed)

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.

Reference Type RESULT
PMID: 26131237 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

qhd20150712

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.