A Randomized Controlled Trial of Postoperative External Fixation in Posterior Cervical Spine Surgery
- Conditions
- Cervical spondylotic myelopathy, cervical ossification of the posterior longitudinal ligamentCervical SpineD055009, C537143
- Registration Number
- JPRN-jRCT1032230433
- Lead Sponsor
- Furuya Takeo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
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).
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of change in Visual Analog Scale (VAS) values of neck pain before and 28 days after surgery
- Secondary Outcome Measures
Name Time Method Secondary safety endpoints<br>Frequency of adverse events<br><br>Secondary efficacy endpoints<br>1) Visual Analog Scale (VAS) value of neck pain<br>2) FACES Pain Rating Scale<br>3) Cervical spine range of motion (forward/backward flexion Xp)<br>4) Cervical sagittal balance C2-7 angle, C2-7 SVA