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

July 9, 2018 updated by: Jiangang Shi, Shanghai Changzheng Hospital

Comparison of Anterior Cervical Anteriodisplacement Fusion and Corpectomy Decompression Fusion in Treatment of Ossification of the Posterior Longitudinal Ligament: A Multi-center，Controlled, Randomized, Open Label Clinical Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Although anterior and posterior decompression surgery are both reported to treat patients with myelopathy caused by OPLL（Posterior longitudinal ligament ossification）. The surgical strategy of the disease is still controversial when the OPLL is multilevel and severe. Novel techniques for better and safer results are required. 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) with myelopathy. 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 and safety of clinical outcomes between ACAF surgery and Anterior cervical corpectomy decompression and fusion（ACCF）in patients with OPLL. 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) Japanese Orthopaedic Association (JOA) scales to assess the spinal cord functions.(2)Visual analogue scale (VAS) to assess pain relief. (3)NURIC Graded to assess walking function.(4) Neck Disabilitv Index(NDI) to assess cervical function . (5) radiological parameters to assess ossification forward distance. And the pre & postoperative radiological parameters, and surgical complications were also investigated. The investigator performing the outcome measures will be blinded to group assignment, and therefore will not participate in treatment. After randomization, the ACAF group will receive anterior controllable antedisplacement and fusion and the ACCF group will receive anterior cervical corpectomy decompression and fusion.

Data Analysis: T test or wilcoxon rank sum test will be used to examine the differences in the five measures between groups and at the six different time frames with the α level set at 0.05. Chi square test will be used to compare the differences in the surgical complications data over time and between groups.

Study Type

Interventional

Enrollment (Anticipated)

840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Shanghai Changzheng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patients aged 45-70 years, without gender limitation, are willing to sign informed consent;
  2. patients diagnosed with posterior longitudinal ligament ossification of the cervical spine;
  3. patients with limbs numbness, walking instability, banding and other spinal cord, nerve root compression symptoms, may be associated with urinary dysfunction, conservative treatment is invalid or gradually increased;

Exclusion Criteria:

  1. Cervical ligamentous ossification, cervical trauma, cervical cancer, cervical tuberculosis and other inflammatory diseases;
  2. accompanied by thoracolumbar spine and other spine parts of the disease affect the clinical symptoms of patients;
  3. associated with amyotrophic lateral sclerosis and other motor neuron diseases and other neurological diseases;
  4. poor health condition, unable to tolerate surgery;
  5. patients (or their guardians) can not give full informed consent for adult dysfunction;
  6. patients who have participated in other clinical trials in the past 1 month
  7. patients with active hepatitis B (including HBeAg) or serological markers (HBsAg or / and HBeAg or / and HBcAb), hepatitis C, tuberculosis, cytomegalovirus infection, severe fungal infection or HIV infection;
  8. patients with active peptic ulcers within 3 months before randomization;
  9. patients with malignant neoplasms;
  10. Vertebral length more than 3 intervertebral spaces.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACAF surgery
Underwent anterior controllable antedisplacement and fusion
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
Placebo Comparator: ACCF surgery
Underwentanterior controllable antedisplacement and fusion
Procedure: ACCF surgery
Removal of the vertebral body，exposed ossification of the posterior longitudinal ligament，and then removed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of patient-reported scores assessing improvement of spinal cord function underwent ACAF surgery compared to ACCF surgery
Time Frame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
JOA total score up to 17 points, the lowest 0 points. The lower the score, the more obvious the dysfunction. Improvement index = post-treatment score - pre-treatment score, post-treatment score improvement rate = [(post-treatment score - pre-treatment score) / 17 - pre-treatment score] × 100%. By improving the index can reflect the improvement of patients before and after treatment and clinical efficacy. The improvement rate can also correspond to the commonly used efficacy criteria: cure is 100% improvement, improvement is greater than 60% effective, 25-60% is effective, and less than 25% is ineffective.
At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of patient-reported scores assessing improvement of Walking function underwent ACAF surgery compared to ACCF surgery
Time Frame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
NURIC Graded presented by NURIC in 1972 used to assess improvement of Walking function。s divided into 6 levels, 0 - Although there are symptoms, but not based on the basis of spinal cord involvement (no limb numbness, decreased muscle strength and other symptoms); Grade 1 - spinal cord involvement (numbness of the limbs, decreased muscle strength and other symptoms), but normal gait; Level 2 ---- mild gait abnormalities, does not affect the work; Level 3 ---- abnormal gait, affecting work; Level 4 ---- Need to support before walking; Level 5 ---- can not walk.
At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
Changes of patient-reported scores assessing improvement of pain underwent ACAF surgery compared to ACCF surgery
Time Frame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
Visual Analogue Scale/Score（VAS） score used to assess improvement of pain.This method is more sensitive and comparable. Draw a 10 cm horizontal line on the paper, one end of the horizontal line is 0, said no pain; the other end of 10, said the pain; the middle part of the pain of varying degrees.
At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
Changes of patient-reported scores assessing improvement of quality of life and cervical function underwent ACAF surgery compared to ACCF surgery
Time Frame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
Neck Disabilitv Index（NDI) used to assess improvement of Quality of life and cervical function.Clinical assessment of cervical function is commonly used, the scale includes the degree of pain, personal food, carrying objects, reading, headache, attention, work, driving, sleep and entertainment in all aspects. Each 5 points, the total score from 0 points (barrier-free) to 50 points (completely paralyzed), the higher the score the heavier the dysfunction.
At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
Changes of patient-reported scores assessing ossification and spinal cord forward distance underwent ACAF surgery compared to ACCF surgery
Time Frame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
radiological parameters used to assess assessing ossification and spinal cord forward distance.The results for the direct measurement of CT and MRI results, the minimum 0mm, the maximum 10mm, the greater the distance forward, indicating that the wider spinal canal, the better the spinal cord decompression, the better the surgical results.
At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Collaborators

Jiangxi Provincial People's Hopital
Xuzhou No.1 Peoples Hospital
No.102 Military Hospital of China Dormitory Area
Shanghai Kaiyuan Orthopedic Hospital
Huaibei Coal Mine General Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

July 9, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZ1805OPLL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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