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

NARecruitingINTERVENTIONAL
Enrollment

164

Participants

Timeline

Start Date

August 17, 2021

Primary Completion Date

July 31, 2025

Study Completion Date

December 31, 2026

Conditions
Ossification of Posterior Longitudinal LigamentCervical 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.

Trial Locations (12)

100053

RECRUITING

Xuanwu Hospital Capital Medical University, Beijing

150086

NOT_YET_RECRUITING

The 2nd Affiliated Hospital of Harbin Medical University, Harbin

200003

RECRUITING

Shanghai Changzheng Hospital, Shanghai

NOT_YET_RECRUITING

Shanghai Sixth People's Hospital, Shanghai

200086

RECRUITING

The First Affiliated Hospital of Shanghai Jiao Tong University, Shanghai

200333

RECRUITING

Shanghai Tongji Hospital, School of Medicine, Tongji University, Shanghai

200433

NOT_YET_RECRUITING

Shanghai Changhai Hospital, Shanghai

266555

RECRUITING

The Affiliated Hospital of Qingdao University, Qingdao

272100

RECRUITING

Affiliated Hospital of Jining Medical University, Jining

518036

RECRUITING

Peking University Shenzhen Hospital, Shenzhen

710000

RECRUITING

The Second Affiliated Hospital, Air Force Medical University, Xi’an

030032

RECRUITING

Shanxi Bethune Hospital, Taiyuan

All Listed Sponsors
collaborator

Changhai Hospital

OTHER

collaborator

Shanghai 6th People's Hospital

OTHER

collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

Peking University Shenzhen Hospital

OTHER

collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

collaborator

Xuanwu Hospital, Beijing

OTHER

collaborator

Jining Medical University

OTHER

collaborator

The Affiliated Hospital of Qingdao University

OTHER

collaborator

Shanxi Bethune Hospital

OTHER

collaborator

Tang-Du Hospital

OTHER

lead

Shanghai Changzheng Hospital

OTHER