Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy

Intervention / Treatment
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* Procedure: ACAF
* Procedure: Laminoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient's age is 18-70 years old, regardless of gender; The patient was diagnosed as severe ossification of the posterior longitudinal ligament (X-ray or CT showed ossification of the posterior longitudinal ligament); The imaging findings showed occupied ratio ≥ 60% or involved three or more segments; Symptoms of spinal cord and nerve root compression, or accompanied by spinal cord compression symptoms such as dysfunction of urination and defecation, conservative treatment was ineffective or aggravated gradually; The participant (or his legal guardian) can sign the informed consent. Exclusion Criteria: Congenital malformations (including but not limited to occipitocervical malformations, congenital cervical fusion, cervical related neurovascular malformations), ossification of cervical ligamentum flavum, cervical trauma, cervical cancer, cervical tuberculosis and other inflammatory diseases; Patients with other spinal diseases such as thoracolumbar vertebrae that affect clinical symptoms; Patients with motor neuron diseases such as amyotrophic lateral sclerosis and other nervous system diseases; The symptoms were aggravated due to recent trauma; Patients who participated in other clinical trials in recent 3 months; The participant (or his legal guardian) with mental illness and cognitive impairment can not give full informed consent; Those who are in poor health and can not tolerate surgery; The patients were not suitable for surgical treatment after preoperative examination.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACAF<br>Participants underwent anterior decompression of Anterior Controllable Antedisplacement and Fusion | Procedure: ACAF<br>* (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.<br>* Other names: Anterior Controllable Antedisplacement and Fusion;|
| Experimental: Laminoplasty<br>Participants underwent posterior decompression of Laminoplasty | Procedure: Laminoplasty<br>* (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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OPLL, Cervical Spondylotic Myelopathy, ACAF, Laminoplasty, Multicenter Study