Clinical trial NCT05001685: Study on the Postoperative Complications and Changes in Posterior Cervical Muscle Volume After Cervical Single Open-door Expansive Laminoplasty With Preservation of Muscular Ligament Complex
Official title: Study on the Postoperative Complications and Changes in Posterior Cervical Muscle Volume After Cervical Single Open-door Expansive Laminoplasty With Preservation of Muscular Ligament Complex
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Myelopathy
Keywords: Single Open-door Expansive Laminoplasty
Preserving the Unilateral Ligament With Muscle Complex
Postoperative Complications
Effects on Posterior Cervical Muscle Volume
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 360
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From 2006 to 2018, the patients admitted to the orthopedic department of our hospital for posterior cervical open-door expansive spinal canal laminoplasty with one side muscle-ligament complex reserved.

Brief summary: In 2006, our hospital improved and began to use cervical expansive open-door laminoplasty preserving the unilateral ligament with muscle complex.The effect of recent follow-up, postoperative complications and their effects on posterior cervical muscle volume were also studied.However, there are few reports about medium and long-term follow-up.

Detailed description: Expansive laminoplasty of posterior cervical canal has been widely used for the treatment of cervical spondylotic myelopathy with cervical spinal stenosis and ossification of the posterior longitudinal ligament since Hirabayashi et al. described it in the 1970s. Traditional single-door surgery requires extensive dissection of both paravertebral muscles and ligaments, and resect part of the spinous process. Postoperative complications (axial neck pain, stiffness, cervical kyphosis, reduced range of motion, etc.) are also related to that in degree. In order to reduce the damage to the posterior cervical structure and reduce the associated complications, in the 1990s, Yoshihiko Oshima et al. introduced the expansive laminoplasty of the spinal canal with one side of the posterior ligamentwith muscle complex attached to the spinous process. In 2006, our hospital improved and began to use cervical expansive open-door laminoplasty preserving the unilateral ligament with muscle complex.The effect of recent follow-up, postoperative complications and their effects on posterior cervical muscle volume were also studied.However, there are few reports about medium and long-term follow-up.

Eligibility criteria: Inclusion Criteria:

* From 2006 to 2018, the patients admitted to the orthopedic department of our hospital for posterior cervical open-door expansive spinal canal laminoplasty with one side muscle-ligament complex reserved.Complete preoperative and postoperative diagnosis and treatment data of our hospital were available, and the follow-up time was ≥2 years.

Exclusion Criteria:

* Patients with incomplete preoperative and postoperative diagnosis and treatment data or less than 2 years of follow-up

Primary outcomes:
measure: Posterior Cervical Muscle Volume
timeFrame: preoperation
measure: Posterior Cervical Muscle Volume
timeFrame: 2 years after operation
measure: C5 palsy
timeFrame: 2 years after operation
measure: axial syndrome
timeFrame: 2 years after operation
measure: reoperation
timeFrame: 2 years after operation
measure: door closing
timeFrame: 2 years after operation
Secondary outcomes:
measure: mJOA
timeFrame: 2 years after operation
measure: NDI
timeFrame: 2 years after operation
measure: VAS
timeFrame: 2 years after operation
measure: ROM
timeFrame: 2 years after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yu Sun, Dr.
role: STUDY_CHAIR
References: