RecruitingNot Applicable

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

China164 participantsStarted 2021-08-17

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The patient's age is 18-70 years old, regardless of gender;
✓. 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;
✓. 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;
✓. The participant (or his legal guardian) can sign the informed consent.

Exclusion criteria

✕. 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;
✕. 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;
✕. The symptoms were aggravated due to recent trauma;
✕. Patients who participated in other clinical trials in recent 3 months;
✕. The participant (or his legal guardian) with mental illness and cognitive impairment can not give full informed consent;
✕. Those who are in poor health and can not tolerate surgery; The patients were not suitable for surgical treatment after preoperative examination.

What they're measuring

C-JOA Recovery Rate

Timeframe: Time point of outcome: 3 months post-operative follow-up visits

C-JOA Recovery Rate

Timeframe: Time point of outcome: 6 months post-operative follow-up visits

C-JOA Recovery Rate

Timeframe: Time point of outcome: 12 months post-operative follow-up visits

C-JOA Recovery Rate

Timeframe: Time point of outcome: 24 months post-operative follow-up visits

Trial details

NCT IDNCT04968028

SponsorShanghai Changzheng Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

Contact for this trial

Dan Han, Master

+86 18317028536 changzhengspine@163.com

View on ClinicalTrials.gov More Ossification of Posterior Longitudinal Ligament trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The patient's age is 18-70 years old, regardless of gender;
✓. 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;
✓. 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;
✓. The participant (or his legal guardian) can sign the informed consent.

Exclusion criteria

✕. 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;
✕. 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;
✕. The symptoms were aggravated due to recent trauma;
✕. Patients who participated in other clinical trials in recent 3 months;
✕. The participant (or his legal guardian) with mental illness and cognitive impairment can not give full informed consent;
✕. Those who are in poor health and can not tolerate surgery; The patients were not suitable for surgical treatment after preoperative examination.