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Comparison of ACAF and ACCF in the Treatment of Cervical OPLL

NCT03312985 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-11-17

No results posted yet for this study

Summary

Background: Dr. Shi recently proposed a new technique as Ossification of anterior decompression surgery, which is also called anterior controllable antedisplacement and fusion (ACAF) , for ossification of the posterior longitudinal ligament (OPLL) and cervical canal stenosis（CSS）. Yet, the effectiveness and safety should be further studied.

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 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

  • Shanghai Changzheng Hospital

    lead OTHER

Principal Investigators

  • Jiangang Shi · 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
2017-05-01
Primary Completion
2021-05-01
Completion
2022-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03312985 on ClinicalTrials.gov