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

Naval Military Medical University (Second Military Medical University)

Status: Enrolling

Conditions: Cervical Spondylosis With Myelopathy; Ossification of Posterior Longitudinal Ligament

Treatments: Procedure: ACAF; Procedure: Laminoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04968028

2021SL029

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

ACAF

Experimental group

Description:

Participants underwent anterior decompression of Anterior Controllable Antedisplacement and Fusion

Treatment:

Procedure: ACAF

Laminoplasty

Experimental group

Description:

Participants underwent posterior decompression of Laminoplasty

Treatment:

Procedure: Laminoplasty