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

JRCT ID: jRCT1032230433

Registered date:05/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cervical spondylotic myelopathy, cervical ossification of the posterior longitudinal ligament
• Date of first enrollment: 05/11/2023
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Postoperative external fixation (soft collar)

Outcome(s)

• Primary Outcome: Amount of change in Visual Analog Scale (VAS) values of neck pain before and 28 days after surgery

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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).

Exclude 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).

Related Information

• Primary Sponsor: Furuya Takeo
• Source(s) of Monetary Support: Clinical Research Initiation Fund (of Chiba Unibersity Hospital),The Japanese Society for Spine Surgery and Related Research Reserved