臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 01, 2025
Last modified on	Oct. 01, 2025
Trial ID	jRCT1022250020

Scientific Title	A case study evaluating the efficacy and safety of endoscopic tendon suturing for finger flexor tendon injuries.
Public Title	A case study of endoscopic tendon suturing for finger flexor tendon injuries.

Contact for Scientific Queries	Name	Matsumoto Yoshihiro
	Affiliation	Fukushima Medical University
	Address	1 Hikarigaoka, Fukushima-shi, Fukushima
	Telephone	+81-24-547-1276
	E-mail	yokotake@fmu.ac.jp
Contact for Public Queries	Name	Yokota Takeru
	Affiliation	Fukushima Medical University
	Address	1 Hikarigaoka, Fukushima-shi, Fukushima
	Telephone	+81-24-547-1276
	E-mail	yokotake@fmu.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Nov. 01, 2025
Target sample size		2
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with finger flexor tendon injuries aged 18 or older at the time of consent. Patients within 72 hours of injury. Patients who have provided written consent.
	Exclusion Criteria	Patients with local infections or skin diseases, or those using medications that increase susceptibility to infection. Patients with a history of tendon suturing or tendon transfer surgery in the affected limb.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		flexor tendon injury
Intervention(s)		Endoscopic Assisted and Direct Visualization Flexor Tendon Suture Technique Procedure. An endoscope is inserted into the tendon sheath through the injury site to visualize the tendon ends, which are then sutured using a 2-strand technique (Reference 3). The suture threads are pulled to expose the tendon ends outside the wound, followed by a total of 6~8 strand sutures under direct visualization. End to end suturing or fixation using suture anchors or suture buttons is performed. Treatment Duration: Observation for 2 years post-surgery. Location: Fukushima Medical University Hospital or Hama-Kosei Hospital.
Health Condition(s) Keyword		tendon injury
Intervention(s) Keyword		tendon repair
Health Condition(s) Code		D013708
Intervention(s) Code		DO13780
Primary Outcome(s)		Joint range of motion at 1~7 days, 2~4 weeks, 2, 3, and 6 months, and 1 and 2 years post-surgery.
Secondary Outcome(s)		Evaluated at 1~7 days, 2~4 weeks, 2, 3, and 6 months, and 1 and 2 years post surgery: Postoperative Performance Evaluation: Pain, edema, and DASH (Disabilities of the Arm, Shoulder, and Hand) score. Complication Evaluation: Tendon adhesion, scarring, and neurovascular injury. Other: Suture time and total operative time.

Primary Sponsor	Yoshihiro Matsumoto

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Fukushima Medical University Certified Review Board
Address	1 Hikarigaoka, Fukushima-shi, Fukushima, Fukushima
Telephone	+81-24-547-1825
E-Mail	fmucrb@fmu.ac.jp
Approval Status	Approval
Date of approval	Sept. 11, 2025

Countries of Recruitment（Except Japan）	none