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Comparison of ACAF and laminoplasty in the Treatment of Cervical Ossification of the Posterior Longitudinal Ligament: a multi-center randomized clinical trial

Comparison of ACAF and laminoplasty in the Treatment of Cervical Ossification of the Posterior Longitudinal Ligament: a multi-center randomized clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026793
Enrollment
Unknown
Registered
2019-10-22
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Ossification of the Posterior Longitudinal Ligament

Interventions

ACAF surgery group:ACAF surgery
Laminoplasty surgery group:Laminoplasty surgery

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) The patient is 45-70 years old and has no gender. He is willing to sign an informed consent form; 2) The patient is diagnosed with ossification of the posterior longitudinal ligament of the cervical spine; 3) The patient's manifestations include spinal cord and nerve root compression symptoms such as numbness, walking instability, and belt sensation, which may be accompanied by dysfunction of the bowel and bladder, and the conservative treatment is ineffective or gradually aggravated.

Exclusion criteria

Exclusion criteria: 1) Cervical spondylosis, ossification of the cervical ligamentum flavum, cervical spine trauma, cervical spondylosis, cervical tuberculosis and other inflammatory diseases; 2) Patients with other spinal diseases such as thoracolumbar spine affect clinical symptoms; 3) Patients with motor neuron diseases such as amyotrophic lateral sclerosis and other neurological diseases; 4) Poor physical condition, unable to tolerate the operator; 5) The patient (or his or her guardian) does not have adequate informed consent for cognitive dysfunction; 6) Patients who participated in other clinical trials within the last month; 7) Active hepatitis B (including Dasanyang or Xiaosanyang) or serological indicators (HBsAg or / and HBeAg or / and HBcAb) positive, hepatitis C, tuberculosis, cytomegalovirus, severe fungal infection or HIV infection; 8) Unhealed active gastrointestinal ulcers within 3 months prior to randomization.

Design outcomes

Primary

MeasureTime frame
JOA;NDI;Nuric classification;SF-36 patient quality of life score;

Secondary

MeasureTime frame
X-ray Cobb angle;Spinal stenosis rate;Progression of bone;Spinal cord compression rate;

Countries

China

Contacts

Public ContactShi Jiangang

Shanghai Changzheng Hospital

shijiangang616@163.com+86 13701668346

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026