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

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 - CeSu Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061284
Enrollment
100
Registered
2026-04-19
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Cervical Myelopathy

Interventions

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

Sponsors

Japan Community Healthcare Organization Osaka Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactShota Takenaka

Japan Community Healthcare Organization Osaka Hospital Department of Orthopaedic Surgery

show@yb3.so-net.ne.jp06-6441-5451

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026