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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036797
Receipt No. R000041914
Scientific Title Flexor tenosynovectomy via two minimal incisions versus single-portal carpal tunnel release in carpal tunnel syndrome treatment: a randomized clinical trial
Date of disclosure of the study information 2019/05/20
Last modified on 2019/05/20

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Basic information
Public title Comparison of outcomes of surgery with transeverse carpal ligament division and without transeverse carpal ligament division for carpal tunnel syndrome
Acronym Outcomes of surgery for carpal tunnel syndrome
Scientific Title Flexor tenosynovectomy via two minimal incisions versus single-portal carpal tunnel release in carpal tunnel syndrome treatment: a randomized clinical trial
Scientific Title:Acronym Flexor tenosynovectomy via two minimal incisions versus single-portal carpal tunnel release in carpal tunnel syndrome treatment
Region
Japan

Condition
Condition idiopathic carpal tunnel syndrome
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 All conventional surgical treatment for carpal tunnel syndrome needs the transverse carpal ligament division. In any conventional surgical treatment for carpal tunnel syndrome, there is a pain in the carpal area after surgery in a certain rate due to the transverse carpal ligament division. Therefore, if the pressure within carpal tunnel can be reduced without the transverse carpal ligament division, pain in carpal area after surgery can be reduced, which is useful for early recovery of the daily and social life. We introduced the technique of flexor tenosynovectomy via two minimal incisions, which does not require the transverse carpal ligament division. Therefore, we compare the outcome of flexor tenosynovectomy via two minimal incisions and single-portal endoscopic carpal tunnel release and investigate the usefulness of flexor tenosynovectomy via two minimal incisions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the presence or absence of pillar pain
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Flexor tenosynovectomy via two minimal incisions
Interventions/Control_2 single-portal carpal tunnel release
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria idiopathic carpal tunnel syndrome
Key exclusion criteria secondary carpal tunnel syndrome
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Hashimoto
Middle name
Last name Akira
Organization Faculty of Medicine, Saga University
Division name Department of Orthopaedic Surgery
Zip code 849-8522
Address Department of Orthopaedic Surgery, Faculty of Medicine, Saga University, Nabeshima 5-1-1, Saga 849-8501, Japan
TEL +81-952-34-2343
Email hassyhashimo@yahoo.co.jp

Public contact
Name of contact person
1st name Hashimoto
Middle name
Last name Akira
Organization Faculty of Medicine, Saga University
Division name Department of Orthopaedic Surgery
Zip code 849-8522
Address Department of Orthopaedic Surgery, Faculty of Medicine, Saga University, Nabeshima 5-1-1, Saga
TEL +81-952-34-2343
Homepage URL
Email hassyhashimo@yahoo.co.jp

Sponsor
Institute Department of Orthopaedic Surgery,Faculty of Medicine, Saga University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tsuruta Orthopaedic Clinic
Address 1241-6, Katsu, Ushizu-cho, Ogi City, Saga 849-8522, Japan
Tel 0952-66-4114
Email t.orth.c@theia.ocn.ne.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 20 Day

Related information
URL releasing protocol https://yahoo.jp/box/vjafsV
Publication of results Partially published

Result
URL related to results and publications https://www.jssh.jp/jssh_manager/CreateHTML.do?syscd=00002700&registcd=J-09000027&abst=
Number of participants that the trial has enrolled 146
Results
The postoperative results of the flexor tenosynovectomy via two minimal incisions in the elderly were poor compared with single-portal carpal tunnel release, the flexor tenosynovectomy via two minimal incisions could obtain better postoperative results compared with single-portal carpal tunnel release in patients <65 years old and did not cause pillar pain. Therefore, the m-FT technique could be a useful alternative to other surgical methods in patients <65 years old.
Results date posted
2019 Year 05 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
146 patients with idiopathic CTS (153 hands) were enrolled in this study
Participant flow
69 patients were in the flexor tenosynovectomy via two minimal incisions group and 77 patients in the single-portal carpal tunnel release group. However, those with inability to fill out self-administered questionnaires, lack of physical examination, terminal latency after operation, or inadequate follow-up (<6 months post operation) were excluded. Finally, 20 patients in thethe flexor tenosynovectomy via two minimal incisions group and 21 patients in the single-portal carpal tunnel release group were included in the analysis.
Adverse events
the patients over 65 years old in the single-portal carpal tunnel release group showed better improvement than those in the flexor tenosynovectomy via two minimal incisions group
Outcome measures
no significant difference in sex, age, affected side, or disease duration was found between the flexor tenosynovectomy via two minimal incisions and  single-portal carpal tunnel release groups  (all patients, over 65 years old group, and under 65 years old group). No patient in the flexor tenosynovectomy via two minimal incisions group (0%) and seven patients in the single-portal carpal tunnel release group (32%) had pillar pain (P<0.05)at 1 month postoperatively. Pillar pain remained in five of the seven cases at 3 months postoperatively and two of the seven cases at 6 months postoperatively. No new cases of pillar pain were observed in the follow-up. In the flexor tenosynovectomy via two minimal incisions and single-portal carpal tunnel release groups including all patients, grip strength temporarily significantly decreased at 1 and 2 months postoperatively and tip pinch (thumb-index finger and thumb-little finger) temporarily significantly decreased at 1 month postoperatively compared with the preoperative values (all P<0.05); however, these parameters improved at 6 months postoperatively to be insignificantly different from before surgery. For the two-point discrimination and terminal latency, the single-portal carpal tunnel release group showed a better improvement than the flexor tenosynovectomy via two minimal incisions group at 3 and 6 months postoperatively (P<0.05). For the Japanese Society for Surgery of the Hand version of the Disability of Arm, Shoulder, and Hand questionnaire, only the single-portal carpal tunnel release group showed improvement at 2, 3, and 6 months postoperatively (P<0.05).The patients over 65 years old in the single-portal carpal tunnel release group showed better improvement than those in the flexor tenosynovectomy via two minimal incisions  group (P<0.05). No significant difference in all parameters between the flexor tenosynovectomy via two minimal incisions  and single-portal carpal tunnel release groups for patients under 65 years old was observed. 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 01 Month 07 Day
Date of IRB
2009 Year 01 Month 08 Day
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2011 Year 07 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 20 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041914

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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