Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04968028
NA

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

Sponsor: Shanghai Changzheng Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

164

Start Date

2021-08-17

Completion Date

2026-12-31

Last Updated

2024-04-17

Healthy Volunteers

No

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.

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