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

Not Applicable

Recruiting

• Conditions: Ossification of Posterior Longitudinal Ligament; Cervical Spondylosis With Myelopathy
• Interventions: Procedure: ACAF; Procedure: Laminoplasty

• Registration Number: NCT04968028
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-18
• Study First Posted: 2021-07-20
• Study Start: 2021-08-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2025-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACAF	ACAF	Participants underwent anterior decompression of Anterior Controllable Antedisplacement and Fusion
Laminoplasty	Laminoplasty	Participants underwent posterior decompression of Laminoplasty

Primary Outcome Measures

Name	Time	Method
C-JOA Recovery Rate	Time point of outcome: 24 months post-operative follow-up visits	(postoperative JOA score at 24 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)\* 100%

Secondary Outcome Measures

Name	Time	Method
Neck Disability Index	28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits	Filling in the 10-item Neck Disability Index scale that totally range 0 to 50 points, the highest index the worst.
Japanese Orthopaedic Association Scores	28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits	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).
Visual Analogue Scale	28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits	Filling in the Visual Analogue Scale pain score that range, 0 \[no pain\] to 10 \[most severe\].
Nurick-Score	28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits	Filling in the 6-level Nurick disability grade scale that range 0 \[mild\] to 5 \[severe\].

Trial Locations

Locations (12)

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

Xuanwu Hospital Capital Medical University; 🇨🇳 Pekin, Pekin, China

The 2nd Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjaing, China

Affiliated Hospital of Jining Medical University; 🇨🇳 Jining, Shandong, China

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Tongji Hospital, School of Medicine, Tongji University; 🇨🇳 Shanghai, Shanghai, China

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital of Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China

Shanghai Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanxi Bethune Hospital; 🇨🇳 Taiyuan, Shanxi, China

The Second Affiliated Hospital, Air Force Medical University; 🇨🇳 Xi'an, Shanxi, China