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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

Furuya Takeo

Chiba University Hospital

1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken

furuya-takeo@chiba-u.jp

Furuya Takeo

Chiba University Hospital

1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken

+81-43-222-7171

furuya-takeo@chiba-u.jp

Recruiting

Nov. 05, 2023

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

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).

Both

Cervical spondylotic myelopathy, cervical ossification of the posterior longitudinal ligament

Postoperative external fixation (soft collar)

Cervical Spine

postoperative external fixation, cervical spondylotic myelopathy, posterior surgery

D055009, C537143

D016267

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

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

+81-43-226-2616

Oct. 16, 2023

No

none