Comparing two surgical methods for treating cervical ossification of the posterior longitudinal ligament
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
This study is testing whether a new surgical method called ACAF is safer and more effective than a traditional surgery called Laminoplasty for adults with severe neck problems caused by ossification of the posterior longitudinal ligament.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Changzheng Hospital Academic / other |
| Locations | 12 sites (Shenzhen, Guangdong and 11 other locations) |
| Trial ID | NCT04968028 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 diagnosed with severe ossification of the posterior longitudinal ligament and experiencing symptoms of spinal cord compression.
Not a fit: Patients with congenital malformations, other spinal diseases, or inflammatory conditions affecting the cervical spine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective surgical option for patients suffering from severe cervical ossification, potentially improving their quality of life.
How similar studies have performed: While there have been studies on surgical interventions for cervical ossification, this specific comparison of ACAF and Laminoplasty is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shenzhen, Guangdong and 11 other locations
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
- The 2nd Affiliated Hospital of Harbin Medical University — Harbin, Heilongjaing, China (Not_yet_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)
- Shanghai Sixth People's Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
- The First Affiliated Hospital of Shanghai Jiao Tong University — Shanghai, Shanghai, China (Recruiting)
- Shanghai Tongji Hospital, School of Medicine, Tongji University — Shanghai, Shanghai, China (Recruiting)
- Shanghai Changhai Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
- Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)
- The Second Affiliated Hospital, Air Force Medical University — Xi'an, Shanxi, China (Recruiting)
Study contacts
- Principal investigator: Yu Chen, Doctor — Shanghai Changzheng Hospital
- Study coordinator: Dan Han, Master
- Email: changzhengspine@163.com
- Phone: +86 18317028536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.