A Multi-center Study：Comparison of ACAF and ACCF in the Treatment of Cervical OPLL

Summary

Background:The ACAF technology has been in clinical trials for some time. More and more doctors are starting to pay attention to this technology. There are many hospitals in China that have developed this technology. In order to prove that this technology has a significant effect on the treatment of cervical ossification of the posterior longitudinal ligament, we compared the efficacy of traditional ACCF surgery, in order to make the conclusion more true, we decided to carry out multi-center research.

Purpose: The aim of this study is to compare the effectiveness of clinical outcomes between ACAF surgery and Anterior cervical corpectomy decompression and fusion（ACCF）in patients with OPLL and CSS . A study hypothesis is that ACAF surgery outcomes will be equal even better and lower surgical complications which compared to ACCF surgery.

Methods: This study is a multi-center randomized clinical trial with randomized, controlled, multicenter research design. The OPLL patients will be randomly assigned in one of the two treatment groups: ACAF surgery and ACCF surgery. Five outcome measures will be collected pre-operative for baseline, and then at1, 12, 24, 48, 96,240weeks post-operative follow-up visits, including: (1)JOA) .(2)VAS. (3)NURIC Graded .(4)NDI . (5) radiological parameter. After randomization, the ACAF group will receive anterior controllable antedisplacement and fusion and the ACCF group will receive anterior cervical corpectomy decompression and fusion.

Conditions

• Ossification of Posterior Longitudinal Ligament

Interventions

PROCEDURE

ACAF surgery

The main surgical procedures include discectomy of the involved levels, thinning of the anterior part of the involved vertebrae, intervertebral cages, anterior plate and screws installation, bilateral osteotomies of the vertebrae, and antedisplacement of the vertebrae-OPLL complex

PROCEDURE

ACCF surgery

Removal of the vertebral body，exposed ossification of the posterior longitudinal ligament，and then removed

Sponsors & Collaborators

• Xuzhou No.1 Peoples Hospital

  collaborator OTHER

• Jiangxi Provincial People's Hopital

  collaborator OTHER

• No.102 Military Hospital of China Dormitory Area

  collaborator OTHER

• Shanghai Kaiyuan Orthopedic Hospital

  collaborator UNKNOWN

• Huaibei Coal Mine General Hospital

  collaborator UNKNOWN

• Shanghai Changzheng Hospital

  lead OTHER

Principal Investigators

• Jiangang MI: Last Name: · Shanghai Changzheng Hospital, Second Military Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2020-01-01

Completion

2023-01-01

Countries

• China

Study Locations