Carpal tunnel: Minimal Invasive Carpal Tunnel Release With the Novel Device -Mini CTS Release- Can Offer Similar Outcomes to the Open Approach in Carpal Tunnel Syndrome.

Sponsor
Kaohsiung Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05067205
Collaborator
(none)
70
2
14.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Carpal tunnel release surgery
N/A

Detailed Description

The current study is the first clinical trial of carpal tunnel syndrome treated by using a device - novel mini CTS releaser. The functional outcome and objective outcome will be recorded to prove the hypothesis that mini CTS releaser can offer similar functional outcomes to the open approach and decrease the complication rate in comparison of the open surgery.

When patients visit, the research physician confirms whether the eligibility criteria are met, and the physician verbally explains the research theme, purpose, and method of execution. After the patient's consent, he should sign the subject consent.

At baseline recruitment, a standardized in-person interview will be conducted by trained and certified study personnel according to structured questionnaires to obtain information on socio-demographic characteristics, habits of tobacco and alcohol use, peripheral blood sample will be also collected from each participant. All of the operated patients underwent a complete personal medical history review, detailed physical examination, as well as routine hematological tests.

Patients will be randomized 1:1 to mini CTS releaser group or to open release group. There will be 35 individuals in each treatment arm. The planned follow-up time will be scheduled.

Safety outcomes including adverse events and changes around surgical wound and neurologic sign will be recorded. Patients will be carefully observed and if any abnormality is noted, appropriate measures will be instituted. The surgical materials used are all certified by the Ministry of Health and Welfare in Taiwan. The possible side effects, such as infections or inflammatory reactions that may occur after surgery, will be given antibiotics or other appropriate treatments in accordance with standard medical procedures.

Data of baseline characteristics will be described using means with standard deviations (SDs) or medians and interquartile ranges (IQRs), or both for continuous variables and using frequencies (percentages) for categorical variables. Mean morphological measures (and changes) will be computed as averages across participants within each treatment group. Between-group baseline comparisons will be based on 2 independent two sample t test or Wilcoxon Mann-Whitney test for quantitative variables, and chi-square test or Fisher's exact test for categorical variables. P values less than 0.05 will be adjusted for multiple comparisons using Bonferroni correction. All statistical analyses will be performed using SAS software Version 9.4 (SAS Institute Inc., Cary, North Carolina).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Minimally Invasive Carpal Tunnel Decompression Using a Novel Ergonomic Releasing Instrument
Anticipated Study Start Date :
Oct 15, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: open release

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

Experimental: mini CTS releaser

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

Outcome Measures

Primary Outcome Measures

  1. Change from preoperative BCTQ SSS at 4 Weeks [preoperative and 4 weeks after surgery]

    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)

Secondary Outcome Measures

  1. Operation time [operation day]

    Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale.

  2. Wound size [Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery]

    Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale.

  3. Grip/pinch strength [Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery]

    Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale.

  4. Pain Scores on the Visual Analog Scale [Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery]

    Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. [0 (no pain), 10 (worst pain)]

  5. Time off work [24 weeks after surgery]

    Differences in time off work between both procedures measured in days.

  6. Number of Participants with Adverse Events [3 days, 2 weeks, 4 weeks and 24 weeks after surgery]

    Infection, secondary operation, scar hypertrophy, scar hyper-sensitivity, tenderness, and pillar pain

  7. two point discrimination test [Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery]

    Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale.

  8. BCTQ SSS [Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 20 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Kaohsiung Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tien-Ching Lee, Orthopedics Attending Physician, Kaohsiung Medical University
ClinicalTrials.gov Identifier:
NCT05067205
Other Study ID Numbers:
  • CTS001
First Posted:
Oct 5, 2021
Last Update Posted:
Oct 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tien-Ching Lee, Orthopedics Attending Physician, Kaohsiung Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2021