Comparing two surgical methods for treating cervical ossification of the posterior longitudinal ligament

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, randomized controlled trial aims to evaluate the safety and efficacy of Anterior Controllable Antedisplacement and Fusion (ACAF) compared to Laminoplasty in patients with severe ossification of the posterior longitudinal ligament. A total of 164 adult participants aged 18-70 will be randomly assigned to either the ACAF or Laminoplasty group in a 1:1 ratio. The study will follow participants for two years to assess outcomes related to efficacy, safety, and imaging results.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting
• Xuanwu Hospital Capital Medical University
  Pekin, Pekin, China Recruiting
• Affiliated Hospital of Jining Medical University
  Jining, Shandong, China Recruiting
• The Affiliated Hospital of Qingdao University
  Qingdao, Shandong, China Recruiting
• Shanghai Changzheng Hospital
  Shanghai, Shanghai, China Recruiting
• The First Affiliated Hospital of Shanghai Jiao Tong University
  Shanghai, Shanghai, China Recruiting

Study contacts

• Principal investigator: Yu Chen, Doctor — Shanghai Changzheng Hospital
• Study coordinator: Dan Han, Master
• Email: changzhengspine@163.com
• Phone: +86 18317028536

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.