UMIN-CTR Clinical Trial

Public title

Development of an effective surgical technique and rehabilitation method when performing tendon graft reconstruction for extensor tendon rupture due to lesions of the wrist

Acronym

Development of an effective surgical technique and rehabilitation method when performing tendon graft reconstruction for extensor tendon rupture due to lesions of the wrist

Scientific Title

Grafted tendon length and excursion after free tendon graft in fingers with extensor tendon ruptures due to distal radioulnar joint lesions

Scientific Title:Acronym

Grafted tendon length and excursion after free tendon graft in fingers with extensor tendon ruptures due to DRUJ lesions

Region

Japan

Condition

Extensor tendon ruptures associated with distal radioulnar lesions

Classification by specialty

Orthopedics

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

An understanding of the excursion or length of the grafted tendon after a tendon graft procedure for the treatment of subcutaneous extensor tendon ruptures due to distal radioulnar lesions is useful for the development of effective surgical technique and rehabilitation protocols. We designed a clinical study in order to clarify these issues.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Grafted tendon excursion immediately, at 1 month, and at more than 12 months after tendon surgery

Key secondary outcomes

Grafted tendon length immediately, at 1 month, and at more than 12 months after tendon surgery

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Stainless steel wires are placed at both ends of the grafted tendon during surgery.

Interventions/Control_2

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

58

years-old

<=

Age-upper limit

84

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients who agreed to join this study among patients with extensor tendon ruptures due to distal radioulnar joint lesion.

Key exclusion criteria

Patients with rheumatoid arthritis lesion classified as Larsen grade III or IV at the distal radioulnar joint.
Patients with rheumatoid arthritis and with apparent swelling or tenderness at the radiocarpal, carpometacarpal, or interphalangeal joints.
Patients with rheumatoid arthritis who showed radiographic progression at the radiocarpal, carpometacarpal, or interphalangeal joints after tendon grafting.
Patients lost to follow up for over 12 months.

Target sample size

20

Name of lead principal investigator

1st name	Hiroyuki
Middle name
Last name	Kato

Organization

Shinshu University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto-city, Nagano

TEL

+81-263-37-2659

Email

hirokato@shinshu-u.ac.jp

Name of contact person

1st name	Shun
Middle name
Last name	Hashimoto

Organization

Shinshu University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto-city, Nagano

TEL

+81-263-37-2659

Homepage URL

Email

hashishun@shinshu-u.ac.jp

Institute

Shinshu University School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shinshu University School of Medicine

Address

3-1-1 Asahi, Matsumoto-city, Nagano

Tel

+81-263-37-2572

Email

mdrinri@shinshu-u.ac.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

2021

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

8

Results

The mean length of the grafted tendon that was measured immediately after tendon grafting was 68 mm (standard deviation (SD) 17), and 74 mm (SD 18) at final follow-up.
Passive excursion was 4 mm (SD 2) immediately after intraoperative tendon grafting, and 7 mm (SD 2) at final follow-up.
Active excursion at final follow-up was 14 mm (SD 4).

Results date posted

2020

Year

12

Month

21

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

58 to 84 years old, 3 males and 5 females

Participant flow

The enrolled subjects were treated by tendon graft and their grafted tendon were measured for each endpoint during surgery, 1 month after surgery, 1 year after surgery, and more than 12 months follow-up.

Adverse events

None

Outcome measures

The length of the grafted tendon
Passive excursion of the grafted tendon
Active excursion of the grafted tendon

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2006

Year

09

Month

01

Day

Date of IRB

2006

Year

12

Month

05

Day

Anticipated trial start date

2007

Year

07

Month

10

Day

Last follow-up date

2021

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

02

Month

18

Day

Last modified on

2022

Year

08

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048844