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

Launched by SHANGHAI CHANGZHENG HOSPITAL · Jul 18, 2021

Keywords

ClinConnect Summary

This clinical trial is comparing two surgical treatments for a condition called ossification of the posterior longitudinal ligament, which can cause severe neck and spinal problems. The two treatments being studied are Anterior Controllable Antedisplacement and Fusion (ACAF) and Laminoplasty. The goal is to see which method works better and is safer for patients experiencing symptoms like nerve pain or difficulties with bladder and bowel control due to spinal cord compression.

To participate in the study, individuals need to be between 18 and 70 years old and have been diagnosed with severe ossification that is affecting at least three segments of their spine. They should also have tried other treatments without improvement. Participants can expect to undergo one of the two surgical procedures and will be monitored for their recovery and outcomes. This study is currently recruiting and aims to help doctors understand which treatment is more effective for patients with this condition.

Gender

ALL

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.