UMIN-CTR Clinical Trial

Public title

A prospective randomized trial comparing absorbable and non-absorbable sutures for postoperative neck pain after cervical laminoplasty

Acronym

CeSu Trial

Scientific Title

A prospective randomized controlled trial comparing absorbable (VICRYL USP 2) and non-absorbable (ETHIBOND USP 2) sutures for deep layer closure in cervical laminoplasty: evaluation of postoperative neck pain, nuchal ligament continuity, and imaging outcomes

Scientific Title:Acronym

CeSu Trial

Region

Japan

Condition

Degenerative Cervical Myelopathy

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the effects of absorbable (VICRYL USP 2) and non-absorbable (ETHIBOND USP 2) sutures used for deep layer closure in cervical laminoplasty on postoperative neck pain, nuchal ligament continuity, and imaging outcomes. The primary endpoint is neck pain at 3 months postoperatively assessed using the 0-100 mm Visual Analog Scale (VAS).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Neck pain at 3 months postoperatively, assessed using the 0-100 mm Visual Analog Scale (VAS)

Key secondary outcomes

1. Nuchal ligament continuity at 6 months postoperatively, assessed on MRI (presence or absence of disruption and the involved level)
2. Neck pain assessed using the 0-100 mm Visual Analog Scale (VAS) preoperatively and at 1, 6, and 12 months postoperatively
3. JOA score, JOACMEQ, EQ-5D, SF-8, and patient satisfaction with surgery assessed preoperatively and at 3, 6, and 12 months postoperatively
4. Radiographic parameters assessed on plain radiographs preoperatively and at 3, 6, and 12 months postoperatively: C2-7 lordosis, T1 slope, C2-7 sagittal vertical axis (C2-7 SVA), and C2-7 range of motion (C2-7 ROM)
5. Wound findings at 1 month postoperatively (+/- 2 weeks) (presence or absence of redness, swelling, discharge, and dehiscence) and skin incision length measured in the neutral position
6. Wound-related complications up to 12 months postoperatively (SSI, hematoma, seroma, wound dehiscence, and suture-related local reactions) and reoperation related to the index surgery

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Group A (absorbable suture group): At the index cervical laminoplasty, polyglactin 910 (VICRYL) USP 2 will be used for closure of the deep layer, defined as the nuchal ligament and contiguous midline ligamentous/fascial complex. Deep layer closure will be performed using interrupted sutures with a standard pitch of approximately 8 mm. The subcutaneous layer will be closed with 2-0 VICRYL, and the skin will be approximated with S-S tape without skin sutures. Perioperative management will follow standard institutional practice and will be unified between groups.

Interventions/Control_2

Group B (non-absorbable suture group): At the index cervical laminoplasty, braided polyester suture (ETHIBOND) USP 2 will be used for closure of the deep layer, defined as the nuchal ligament and contiguous midline ligamentous/fascial complex. Deep layer closure will be performed using interrupted sutures with a standard pitch of approximately 8 mm. The subcutaneous layer will be closed with 2-0 VICRYL, and the skin will be approximated with S-S tape without skin sutures. Perioperative management will follow standard institutional practice and will be unified between groups.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients scheduled to undergo elective cervical laminoplasty at our institution.
2. Age >=20 years.
3. Patients diagnosed with degenerative cervical myelopathy (primarily cervical spondylotic myelopathy, ossification of the posterior longitudinal ligament, or cervical disc herniation) and deemed suitable for laminoplasty.
4. Patients who have provided written informed consent.
5. The standard surgical procedure is laminoplasty from C3 to C6 with or without C7 cephalic dome-like laminotomy.
6. Permitted additional procedures include caudal or ventral decompression at C2, concomitant foraminotomy, and conversion to laminectomy for up to two laminae.

Key exclusion criteria

1. Patients undergoing revision surgery.
2. Patients in whom non-degenerative conditions, such as infection, tumor, or trauma, are the primary pathology.
3. Patients in whom identification of posterior supporting structures or standardized deep layer closure is expected to be markedly difficult (e.g., due to severe scarring).
4. Patients deemed inappropriate for inclusion by the principal investigator.
5. Patients undergoing additional procedures at the laminoplasty levels, including C1 posterior arch resection, procedures involving detachment of muscles attached to C2, or resection of the C7 spinous process, as well as those requiring conversion to laminectomy involving three or more laminae.

Target sample size

100

Name of lead principal investigator

1st name	Shota
Middle name
Last name	Takenaka

Organization

Japan Community Healthcare Organization Osaka Hospital

Division name

Department of Orthopaedic Surgery

Zip code

553-0003

Address

4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan

TEL

06-6441-5451

Email

show@yb3.so-net.ne.jp

Name of contact person

1st name	Shota
Middle name
Last name	Takenaka

Organization

Japan Community Healthcare Organization Osaka Hospital

Division name

Department of Orthopaedic Surgery

Zip code

553-0003

Address

4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan

TEL

06-6441-5451

Homepage URL

Email

show@yb3.so-net.ne.jp

Institute

Japan Community Healthcare Organization Osaka Hospital

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

Japan Community Healthcare Organization Osaka Hospital Ethics Committee

Address

4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan

Tel

06-6441-5451

Email

horimoto-takiko@osaka.jcho.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

独立行政法人地域医療機能推進機構大阪病院（大阪府） / Japan Community Healthcare Organization Osaka Hospital (Osaka, Japan)

Date of disclosure of the study information

2026

Year

04

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

No

IPD sharing Plan description

There is no current plan to share de-identified individual participant data with external investigators.

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

03

Month

15

Day

Date of IRB

2026

Year

04

Month

15

Day

Anticipated trial start date

2026

Year

04

Month

20

Day

Last follow-up date

2027

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Randomization
Patients will be enrolled preoperatively and allocated 1:1 using variable block randomization (block sizes 4, 6, 8) generated in R. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes (SNOSE), opened on the day of surgery.

Procedures
Deep layer (nuchal ligament and contiguous midline fascial complex) will be closed with the allocated suture using interrupted sutures (pitch ~8 mm). The subcutaneous layer will be closed with 2-0 VICRYL, and the skin will be approximated with S-S tape without skin sutures. Perioperative management will follow standard institutional practice and be unified between groups.

Analgesics
Postoperative analgesic use will not be restricted. At 3 months, analgesic use during the preceding 7 days (use/non-use, type, scheduled or as-needed, dose/frequency, indication) will be recorded.

Imaging
No additional imaging will be performed for research purposes. Only routine clinical images will be used. Imaging will be assessed by blinded evaluators when feasible.

Protocol deviations
Safety takes priority. Reinforcement or additional procedures are permitted if necessary. Use of non-allocated deep sutures or major deviation from the standardized closure will be recorded as major protocol deviations.

Registered date

2026

Year

04

Month

17

Day

Last modified on

2026

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069803