Comparison of ACAF and ACCF in the Treatment of Cervical OPLL

NCT03312985 | Unknown

• 1 other identifier: CZ1707OPLL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ossification of Posterior Longitudinal Ligament

Outcome Measures

Primary Outcomes (1)

• Changes of patient-reported scores assessing improvement of spinal cord function underwent ACAF surgery compared to ACCF surgery

  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 Outcomes (4)

• Changes of patient-reported scores assessing improvement of Walking function underwent ACAF surgery compared to ACCF surgery

  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

  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

  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

  At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.

Study Arms (2)

ACAF surgery

EXPERIMENTAL

Underwent anterior controllable antedisplacement and fusion

Procedure: ACAF surgery

ACCF surgery

PLACEBO COMPARATOR

Underwentanterior controllable antedisplacement and fusion

Procedure: ACCF surgery

Interventions

ACAF surgery 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

ACAF surgery

ACCF surgery PROCEDURE

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

ACCF surgery

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 45-70 years, without gender limitation, are willing to sign informed consent;
• patients diagnosed with posterior longitudinal ligament ossification of the cervical spine;
• 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;

You may not qualify if:

• Cervical ligamentous ossification, cervical trauma, cervical cancer, cervical tuberculosis and other inflammatory diseases;
• accompanied by thoracolumbar spine and other spine parts of the disease affect the clinical symptoms of patients;
• associated with amyotrophic lateral sclerosis and other motor neuron diseases and other neurological diseases;
• poor health condition, unable to tolerate surgery;
• patients (or their guardians) can not give full informed consent for adult dysfunction;
• patients who have participated in other clinical trials in the past 1 month
• 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;
• patients with active peptic ulcers within 3 months before randomization.
• patients with malignant neoplasms

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200001, China

Location

Related Publications (1)

• 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.

  PMID: 25000183 BACKGROUND

MeSH Terms

Conditions

Ossification of Posterior Longitudinal Ligament

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ossification, Heterotopic; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiangang Shi

  Shanghai Changzheng Hospital, Second Military Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analysist do not know the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of No.2 department of spinal surgery

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 18, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2021
• Study Completion: January 1, 2022
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

CN (1)