Clinical trial NCT04968028: Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ossification of Posterior Longitudinal Ligament
Cervical Spondylosis With Myelopathy
Keywords: OPLL
Cervical Spondylotic Myelopathy
ACAF
Laminoplasty
Multicenter Study
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Shanghai 6th People's Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Tongji Hospital
name: Peking University Shenzhen Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: Xuanwu Hospital, Beijing
name: Jining Medical University
name: The Affiliated Hospital of Qingdao University
name: Shanxi Bethune Hospital
name: Tang-Du Hospital
First posted: 2021-07-20
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: C-JOA Recovery Rate
timeFrame: Time point of outcome: 3 months post-operative follow-up visits
measure: C-JOA Recovery Rate
timeFrame: Time point of outcome: 6 months post-operative follow-up visits
measure: C-JOA Recovery Rate
timeFrame: Time point of outcome: 12 months post-operative follow-up visits
measure: C-JOA Recovery Rate
timeFrame: Time point of outcome: 24 months post-operative follow-up visits
Secondary outcomes:
measure: Japanese Orthopaedic Association Scores
timeFrame: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
measure: Visual Analogue Scale
timeFrame: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
measure: Neck Disability Index
timeFrame: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
measure: Nurick-Score
timeFrame: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
state: Heilongjaing
city: Pekin
country: China
facility: Xuanwu Hospital Capital Medical University
state: Pekin
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: The First Affiliated Hospital of Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongji Hospital, School of Medicine, Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital, Air Force Medical University
state: Shanxi
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Jiangang Shi, Doctor
role: STUDY_CHAIR
affiliation: Shanghai Changzheng Hospital
name: Dan Han, Master
role: STUDY_DIRECTOR
affiliation: Shanghai Changzheng Hospital
name: Yu Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.