NCT05067205

Brief Summary

This is a prospective, open-label, parallel-group, randomized controlled trial to evaluate the postoperative outcome after carpal tunnel release by using mini CTS releaser and open method with duration of 6 months estimated. The study hypothesis is that mini CTS releaser can offer similar functional outcomes to the open approach and avoid the complications of the open surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 8, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 5, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

September 8, 2021

Last Update Submit

May 3, 2023

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change from preoperative BCTQ SSS at 4 Weeks

    The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms)

    preoperative and 4 weeks after surgery

Secondary Outcomes (8)

  • Operation time

    operation day

  • Wound size

    Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery

  • Grip/pinch strength

    Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery

  • Pain Scores on the Visual Analog Scale

    Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery

  • Time off work

    24 weeks after surgery

  • +3 more secondary outcomes

Study Arms (2)

open release

SHAM COMPARATOR

A prospective, open-label, parallel-group to evaluate the postoperative outcome after carpal tunnel release by using open carpal tunnel release method with duration of 6 months estimated.

Procedure: Carpal tunnel release surgery

mini CTS releaser

EXPERIMENTAL

A prospective, open-label, parallel-group to evaluate the postoperative outcome after carpal tunnel release by using mini CTS releaser method with duration of 6 months estimated.

Procedure: Carpal tunnel release surgery

Interventions

Carpal tunnel release surgeryPROCEDURE

Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks postoperatively

mini CTS releaseropen release

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and above.
  • clinically symptomatic and electrophysiologically confirmed carpal tunnel syndrome.
  • no response to conservative treatment.
  • Signed Informed Consent and willing to comply with doctors and nurses' order.

You may not qualify if:

  • Subjects with recurrent carpal tunnel syndrome
  • Subjects with coexisting cervical radiculopathy
  • Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolone per day or equivalent.
  • Diabetic patients with pre-OP HbA1c \>7%
  • Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
  • Known allergy/hypersensitivity to any of the components included into the investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

Related Publications (1)

  • Chen HF, Chang SM, Kao CM, Chen YL, Kao LT, Hsu YC, Fu YC, Wang YH, Liu WC, Lee TC. Novel minimally invasive carpal tunnel release using a specialized surgical kit: a prospective multi-center case series. BMC Musculoskelet Disord. 2025 Apr 8;26(1):346. doi: 10.1186/s12891-025-08612-0.

    PMID: 40200263DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedics Attending Physician

Study Record Dates

First Submitted

September 8, 2021

First Posted

October 5, 2021

Study Start

September 8, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

TW(1)