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.
This is a national, multicenter, prospective, randomized controlled trial to compare the safety and efficacy of ACAF and posterior laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament. In this study, 164 adult patients aged 18-70 with severe copll were randomly assigned to the experimental group (using ACAF) and the control group (using lamp) according to the ratio of 1:1. The patients were followed up for 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
(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.
(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.
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
RECRUITINGThe 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjaing, China
C-JOA Recovery Rate
(postoperative JOA score at 3 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)\* 100%
Time frame: Time point of outcome: 3 months post-operative follow-up visits
C-JOA Recovery Rate
(postoperative JOA score at 6 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)\* 100%
Time frame: Time point of outcome: 6 months post-operative follow-up visits
C-JOA Recovery Rate
(postoperative JOA score at 12 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)\* 100%
Time frame: Time point of outcome: 12 months post-operative follow-up visits
C-JOA Recovery Rate
(postoperative JOA score at 24 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)\* 100%
Time frame: Time point of outcome: 24 months post-operative follow-up visits
Japanese Orthopaedic Association Scores
Filling in the Japanese Orthopaedic Association Scores scale. This scale involves four aspects: upper limb motor function (range, 0 to 4 points), lower limb motor function (range, 0 to 4 points), sensory function (range, 0 to 6 points), and bladder function (range, 0 to 3 points). The total C-JOA score ranged from 0 (worst) to 17 (normal condition).
Time frame: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Visual Analogue Scale
Filling in the Visual Analogue Scale pain score that range, 0 \[no pain\] to 10 \[most severe\].
Time frame: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
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Xuanwu Hospital Capital Medical University
Beijing, Pekin, China
RECRUITINGAffiliated Hospital of Jining Medical University
Jining, Shandong, China
RECRUITINGThe Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
RECRUITINGShanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Tongji Hospital, School of Medicine, Tongji University
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITING...and 2 more locations
Neck Disability Index
Filling in the 10-item Neck Disability Index scale that totally range 0 to 50 points, the highest index the worst.
Time frame: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Nurick-Score
Filling in the 6-level Nurick disability grade scale that range 0 \[mild\] to 5 \[severe\].
Time frame: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits