NCT04968028

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a national, multicenter, prospective, randomized controlled trial to compare the safety and efficacy of ACAF and posterior laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament. In this study, 164 adult patients aged 18-70 with severe copll were randomly assigned to the experimental group (using ACAF) and the control group (using lamp) according to the ratio of 1:1. The patients were followed up for 2 years.

Conditions

• Ossification of Posterior Longitudinal Ligament
• Cervical Spondylosis With Myelopathy

Interventions

Type	Name	Description
PROCEDURE	ACAF	(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.
PROCEDURE	Laminoplasty	(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.

Timeline

• Start date: 2021-08-17
• Primary completion: 2025-07-31
• Completion: 2026-12-31
• First posted: 2021-07-20
• Last updated: 2024-04-17

Locations

12 sites across 1 country: China