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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-17

Study Completion Date

2026-12-31

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.

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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.

Conditions

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Ossification of Posterior Longitudinal Ligament Cervical Spondylosis With Myelopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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ACAF

Participants underwent anterior decompression of Anterior Controllable Antedisplacement and Fusion

Group Type EXPERIMENTAL

ACAF

Intervention Type 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.

Laminoplasty

Participants underwent posterior decompression of Laminoplasty

Group Type EXPERIMENTAL

Laminoplasty

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

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Anterior Controllable Antedisplacement and Fusion

Eligibility Criteria

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Inclusion Criteria

1. The patient's age is 18-70 years old, regardless of gender;
2. 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;
3. 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;
4. The participant (or his legal guardian) can sign the informed consent.

Exclusion Criteria

1. 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;
2. 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;
3. The symptoms were aggravated due to recent trauma;
4. Patients who participated in other clinical trials in recent 3 months;
5. The participant (or his legal guardian) with mental illness and cognitive impairment can not give full informed consent;
6. Those who are in poor health and can not tolerate surgery; The patients were not suitable for surgical treatment after preoperative examination.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years