UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036797 |
|---|---|
| Receipt number | 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 11:07:13 |
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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
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
hassyhashimo@yahoo.co.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery,Faculty of Medicine, Saga University
Institute
Department
Personal name
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
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®istcd=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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041914
