Comparison of ACAF and ACCF in the Treatment of Cervical OPLL

NCT ID: NCT03312985

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2022-01-01

Brief 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.

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. Yet, the effectiveness and safety should be further studied.

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 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.

Conditions

Ossification of Posterior Longitudinal Ligament

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ACAF surgery

Underwent anterior controllable antedisplacement and fusion

Group Type: EXPERIMENTAL

ACAF surgery

Intervention Type: PROCEDURE

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

ACCF surgery

Underwentanterior controllable antedisplacement and fusion

Group Type: PLACEBO_COMPARATOR

ACCF surgery

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

ACCF surgery

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jiangang Shi

Chief of No.2 department of spinal surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiangang Shi

Role: STUDY_CHAIR

Shanghai Changzheng Hospital, Second Military Medical University

Locations

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Chen Y, Yang L, Liu Y, Yang H, Wang X, Chen D. Surgical results and prognostic factors of anterior cervical corpectomy and fusion for ossification of the posterior longitudinal ligament. PLoS One. 2014 Jul 7;9(7):e102008. doi: 10.1371/journal.pone.0102008. eCollection 2014.

Reference Type: BACKGROUND

PMID: 25000183 (View on PubMed)

Other Identifiers

CZ1707OPLL

Identifier Type: -

Identifier Source: org_study_id