UMIN-CTR Clinical Trial

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

idiopathic carpal tunnel syndrome

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

the presence or absence of pillar pain

Key secondary outcomes

Study type

Interventional

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

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

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

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

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

Institute

Department of Orthopaedic Surgery,Faculty of Medicine, Saga University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

05

Month

20

Day

URL releasing protocol

https://yahoo.jp/box/vjafsV

Publication of results

Partially published

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

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 related 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