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Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament
Sponsor: Shanghai Changzheng Hospital
Summary
The purpose of this study is to compare the efficacy, safety and imaging outcomes between Anterior Controllable Antedisplacement and Fusion (ACAF) and Laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament.
Official title: An Open-label Randomized Multi-centre Study to Evaluate Anterior Controllable Antedisplacement and Fusion Versus Posterior Laminoplasty in Patients With Cervical Ossification of the Posterior Longitudinal Ligament
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
164
Start Date
2021-08-17
Completion Date
2026-12-31
Last Updated
2024-04-17
Healthy Volunteers
No
Interventions
ACAF
(1)A standard right-side Smith-Robinson approach is performed. (2) The involved disc tissues are removed. The posterior longitudinal ligament is cut down at the levels cephalic and caudal to OPLL. (3) The anterior portion of the middle vertebral bodies is removed according to the thickness of ossification. Suitable cages are placed into each intervertebral space. (4) On the left side of the vertebra, a 2-mm-wide groove is created at the medial border of the transverse foramina. After that, an curved plated is fixed with screws. (5) On the right side of the vertebrae, a similar groove was also created. (6) Finally, tightening the screws to achieve a gradual evaluation of the vertebrae with OPLL.
Laminoplasty
(1) In the prone position, the skin and nuchal ligament were cut through the posterior median incision, and the paravertebral muscles were stripped layer by layer to expose the bilateral vertebral lamina, lateral mass and articular process.(2) Part of spinous process were removed with bone biting forceps. The side with more severe symptoms was selected as the open side, bone groove was performed at 2-3 mm of the medial edge of bilateral facet joints with the medial cortex was reserved at the shaft side.(3) Slowly lift the lamina and maintained.(4)Determining the opening width of each segment by trial, and selecting the appropriate size Arch miniplate, and fixed with screws.
Locations (12)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjaing, China
Xuanwu Hospital Capital Medical University
Beijing, Pekin, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Shanghai Tongji Hospital, School of Medicine, Tongji University
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The Second Affiliated Hospital, Air Force Medical University
Xi’an, Shanxi, China