RecruitingNot ApplicableNCT04968028

Multi-centre Study to Evaluate ACAF Versus Laminoplasty in 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


Sponsor

Shanghai Changzheng Hospital

Enrollment

164 participants

Start Date

Aug 17, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This multi-center Chinese study compares two surgical approaches — ACAF (anterior controllable antedisplacement and fusion) versus laminoplasty — for treating severe ossification of the posterior longitudinal ligament (OPLL), a condition where a ligament in the neck hardens and presses on the spinal cord. You may be eligible if: - You are between 18 and 70 years old - You have been diagnosed with severe OPLL (confirmed by X-ray or CT, with canal occupation ≥60% or involving 3 or more spinal segments) - You have symptoms of spinal cord compression (weakness, numbness, or bladder/bowel dysfunction) that have not improved with conservative treatment - You or your legal guardian can sign informed consent You may NOT be eligible if: - You have congenital spinal malformations, cervical fractures, tumors, or tuberculosis - You have other spinal conditions or neurological diseases (e.g., ALS) affecting your symptoms - Your symptoms worsened due to a recent trauma - You have participated in another clinical trial in the past 3 months - You are medically unfit for surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREACAF

(1)A standard right-side Smith-Robinson approach is performed. (2) The involved disc tissues are removed. The posterior longitudinal ligament is cut down at the levels cephalic and caudal to OPLL. (3) The anterior portion of the middle vertebral bodies is removed according to the thickness of ossification. Suitable cages are placed into each intervertebral space. (4) On the left side of the vertebra, a 2-mm-wide groove is created at the medial border of the transverse foramina. After that, an curved plated is fixed with screws. (5) On the right side of the vertebrae, a similar groove was also created. (6) Finally, tightening the screws to achieve a gradual evaluation of the vertebrae with OPLL.

PROCEDURELaminoplasty

(1) In the prone position, the skin and nuchal ligament were cut through the posterior median incision, and the paravertebral muscles were stripped layer by layer to expose the bilateral vertebral lamina, lateral mass and articular process.(2) Part of spinous process were removed with bone biting forceps. The side with more severe symptoms was selected as the open side, bone groove was performed at 2-3 mm of the medial edge of bilateral facet joints with the medial cortex was reserved at the shaft side.(3) Slowly lift the lamina and maintained.(4)Determining the opening width of each segment by trial, and selecting the appropriate size Arch miniplate, and fixed with screws.


Locations(12)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjaing, China

Xuanwu Hospital Capital Medical University

Beijing, Pekin, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Shanghai Tongji Hospital, School of Medicine, Tongji University

Shanghai, Shanghai Municipality, China

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

The Second Affiliated Hospital, Air Force Medical University

Xi’an, Shanxi, China

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NCT04968028


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