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

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.

Conditions

• Ossification of Posterior Longitudinal Ligament
• Cervical Spondylosis With Myelopathy

Interventions

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.

Sponsors & Collaborators

• Changhai Hospital

  collaborator OTHER

• Shanghai 6th People's Hospital

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Peking University Shenzhen Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Affiliated Hospital of Jining Medical University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Shanxi Bethune Hospital

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• Shanghai Changzheng Hospital

  lead OTHER

Principal Investigators

• Jiangang Shi, Doctor · Shanghai Changzheng Hospital

• Dan Han, Master · Shanghai Changzheng Hospital

• Yu Chen, Doctor · Shanghai Changzheng Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-17

Primary Completion

2027-07-31

Completion

2027-12-31

Countries

• China

Study Locations