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Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release

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Mayo Clinic

Status

Completed

Conditions

Carpal Tunnel Syndrome

Treatments

Procedure: Incisionless Threaded Carpal Tunnel
Procedure: Standard Mini-Open Carpal Tunnel

Study type

Interventional

Funder types

Other

Identifiers

NCT04101955
18-010569

Details and patient eligibility

About

The overarching long-term goal is to develop a CTS Treatment Center within the Hand Clinic that offers a variety of established and emerging treatment options in a multidisciplinary program. The ultra-minimally invasive carpal tunnel release would be one component of the program. Furthering the knowledge with regard to ultra-minimally invasive carpal tunnel release outcomes would facilitate the Hand Clinics ability to offer this procedure as a component of individualized care in the CTS Treatment Center to facilitate delivery of the appropriate level of care to the right patient.

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A diagnosis of CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months
  • Age 18-65 years old
  • 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
  • Ability to complete all follow up appointments

Exclusion criteria

  • Previous CTS surgical release on affected side
  • Diabetes mellitus
  • Hypothyroidism
  • Hand arthritis (rheumatologic or osteoarthritis)
  • Pregnancy
  • Electromyographic evidence of any condition other than CTS affecting the hand
  • Workman's compensation
  • Participants not willing to make follow-up visits

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Incisionless Threaded Carpal Tunnel
Other group
Treatment:
Procedure: Standard Mini-Open Carpal Tunnel
Procedure: Incisionless Threaded Carpal Tunnel
Standard Mini-Open Carpal Tunnel
Other group
Treatment:
Procedure: Standard Mini-Open Carpal Tunnel
Procedure: Incisionless Threaded Carpal Tunnel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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