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| Name | Class |
|---|---|
| Changhai Hospital | OTHER |
| Shanghai 6th People's Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACAF | Experimental | Participants underwent anterior decompression of Anterior Controllable Antedisplacement and Fusion |
|
| Laminoplasty | Experimental | Participants underwent posterior decompression of Laminoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACAF | Procedure | (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. |
| Measure | Description | Time Frame |
|---|---|---|
| C-JOA Recovery Rate | (postoperative JOA score at 3 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100% | 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 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 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 point of outcome: 24 months post-operative follow-up visits |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiangang Shi, Doctor | Shanghai Changzheng Hospital | Study Chair |
| Dan Han, Master | Shanghai Changzheng Hospital | Study Director |
| Yu Chen, Doctor | Shanghai Changzheng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | 100053 | China | ||
| Peking University Shenzhen Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32097261 | Background | Chen Y, Sun J, Yuan X, Guo Y, Yang H, Chen D, Shi J. Comparison of Anterior Controllable Antedisplacement and Fusion With Posterior Laminoplasty in the Treatment of Multilevel Cervical Ossification of the Posterior Longitudinal Ligament: A Prospective, Randomized, and Control Study With at Least 1-Year Follow Up. Spine (Phila Pa 1976). 2020 Aug 15;45(16):1091-1101. doi: 10.1097/BRS.0000000000003462. | |
| 31797138 |
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| Tongji Hospital |
| OTHER |
| Peking University Shenzhen Hospital | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| Affiliated Hospital of Jining Medical University | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| Shanxi Bethune Hospital | OTHER |
| Tang-Du Hospital | OTHER |
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In view of the obvious differences between the two surgery methods, this study was designed as an open-label trial. However, the results of X-ray, computed tomography (CT) and magnetic resonance imaging (MRI) will be independently reviewed by an independent radiographic review committee in a blind fashion in addition to the evaluation by site investigators.
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| Laminoplasty | Procedure | (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. |
|
| Visual Analogue Scale | Filling in the Visual Analogue Scale pain score that range, 0 [no pain] to 10 [most severe]. | 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits |
| Neck Disability Index | Filling in the 10-item Neck Disability Index scale that totally range 0 to 50 points, the highest index the worst. | 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]. | 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits |
| Shenzhen |
| Guangdong |
| 518036 |
| China |
| The 2nd Affiliated Hospital of Harbin Medical University | Harbin | Heilongjaing | 150086 | China |
| Affiliated Hospital of Jining Medical University | Jining | Shandong | 272100 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266555 | China |
| Shanghai Changzheng Hospital | Shanghai | Shanghai Municipality | 200003 | China |
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | 200003 | China |
| The First Affiliated Hospital of Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200086 | China |
| Shanghai Tongji Hospital, School of Medicine, Tongji University | Shanghai | Shanghai Municipality | 200333 | China |
| Shanghai Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | 030032 | China |
| The Second Affiliated Hospital, Air Force Medical University | Xi’an | Shanxi | 710000 | China |
| Background |
| Sun K, Wang S, Huan L, Sun J, Xu X, Sun X, Shi J, Guo Y. Analysis of the spinal cord angle for severe cervical ossification of the posterior longitudinal ligament: comparison between anterior controllable antedisplacement and fusion (ACAF) and posterior laminectomy. Eur Spine J. 2020 May;29(5):1001-1012. doi: 10.1007/s00586-019-06216-6. Epub 2019 Dec 3. |
| 34496821 | Derived | Chen Y, Sun J, Han D, Yuan X, Wang Y, Guo Y, Zhong X, Shi J. 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: study design and analysis plan (STAR). BMC Musculoskelet Disord. 2021 Sep 8;22(1):765. doi: 10.1186/s12891-021-04645-3. |
| ID | Term |
|---|---|
| D017887 | Ossification of Posterior Longitudinal Ligament |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009999 | Ossification, Heterotopic |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D050939 | Gene Fusion |
| D065406 | Laminoplasty |
| ID | Term |
|---|---|
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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