A Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome (TTP-50)

Mayo Clinic

Status: Terminated

Conditions: Carpal Tunnel Syndrome Bilateral

Treatments: Procedure: Carpal Tunnel Procedure (open)

Study type: Interventional

Funder types: Other

Identifiers

NCT03906604

18-010050

Details and patient eligibility

About

To compare the incisionless thread carpal tunnel release with the standard mini-open carpal tunnel release (standard of care) in patients with bilateral carpal tunnel syndrome. Patients with bilateral CTS will have one side released with incisionless thread carpal tunnel release and the contralateral side released with the mini-open carpal tunnel release. The investigators hypothesize that the incisionless thread carpal tunnel release (TCTR) will be no different than the standard mini-open release (MOR) with regard to symptom improvement and safety and will be less painful, result in quicker return to work and will be less costly.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A diagnosis of bilateral CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months
• Willingness to undergo bilateral carpal tunnel surgical treatment with one side having the TCTR and the other a mini open carpal tunnel release
• Age 18-65 years of age
• Clinical examination findings (compression test, Tinels, Phalens, etc) consistent with carpal tunnel syndrome.
• Persistence of symptoms after 6 weeks of conservative treatment such as splinting, activity modification, and/or injection therapy.
• Electromyographic evidence of mild, moderate, moderately severe, or severe median nerve neuropathy at the wrist
• Able and willing to complete all follow-up appointments

Exclusion criteria

• Previous CTS surgical release on any of their hands
• Diabetes mellitus
• Hypothyroidism
• Significant Hand arthritis (rheumatologic or osteoarthritis)
• Pregnancy
• Electromyographic evidence of any condition other than CTS affecting the hand
• Workman's compensation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Dominant hand-open Carpal Tunnel Release

Other group

Description:

Standard mini-open carpal tunnel release (standard of care) on the dominant hand.

Treatment:

Procedure: Carpal Tunnel Procedure (open)

Dominant hand-Incisionless thread carpal tunnel release

Other group

Description:

Incisionless thread carpal tunnel release on the dominant hand.

Treatment:

Procedure: Carpal Tunnel Procedure (open)