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A Randomized Controlled Trial of Postoperative External Fixation in Posterior Cervical Spine Surgery

A Randomized Controlled Trial of Postoperative External Fixation in Posterior Cervical Spine Surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032230433
Enrollment
120
Registered
2023-11-05
Start date
2024-02-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Cervical spondylotic myelopathy, cervical ossification of the posterior longitudinal ligament Cervical Spine

Interventions

Postoperative external fixation (soft collar)

Sponsors

Maki Satoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients undergoing cervical back surgery (laminoplasty or laminectomy) with a diagnosis of cervical spondylotic myelopathy or cervical posterior longitudinal ligament ossification 2)Eligible age range is 20 to 85 years old 3)Gender is irrelevant 4)Patients who can come to the hospital for 3 months after the surgery (however, follow-up is performed for 2 years after the surgery, so patients who can come to the hospital for 2 years are preferred if possible).

Exclusion criteria

Exclusion criteria: 1) History of cervical spine surgery (including previous methods) 2)Patients with skin diseases such as atopic dermatitis that make postoperative external fixation difficult 3) Patients with impaired consciousness 4) Patients with concomitant neurological diseases that may affect the evaluation of neurological symptoms, such as cerebral infarction 5) Other patients who are judged to be inappropriate as subjects by the study investigator (subinvestigator).

Design outcomes

Primary

MeasureTime frame
Amount of change in Visual Analog Scale (VAS) values of neck pain before and 28 days after surgery

Secondary

MeasureTime frame
Secondary safety endpoints Frequency of adverse events Secondary efficacy endpoints 1) Visual Analog Scale (VAS) value of neck pain 2) FACES Pain Rating Scale 3) Cervical spine range of motion (forward/backward flexion Xp) 4) Cervical sagittal balance C2-7 angle, C2-7 SVA

Contacts

Public ContactTakeo Furuya

Chiba University Hospital

furuya-takeo@chiba-u.jp+81-43-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026