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

NCT03591692 | Unknown

• 1 other identifier: CZ1805OPLL
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief 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

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;
• Vertebral length more than 3 intervertebral spaces.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200001, China

Location

Related Publications (6)

• Sun JC, Zhang B, Shi J, Sun KQ, Huan L, Sun XF, Liu N, Zheng B, Wang HB. Can K-Line Predict the Clinical Outcome of Anterior Controllable Antedisplacement and Fusion Surgery for Cervical Myelopathy Caused by Multisegmental Ossification of the Posterior Longitudinal Ligament? World Neurosurg. 2018 Aug;116:e118-e127. doi: 10.1016/j.wneu.2018.04.128. Epub 2018 Apr 27.

  PMID: 29709746 BACKGROUND

• Yang H, Sun J, Shi J, Yang Y, Guo Y, Zheng B, Wang Y. In Situ Decompression to Spinal Cord During Anterior Controllable Antedisplacement Fusion Treating Degenerative Kyphosis with Stenosis: Surgical Outcomes and Analysis of C5 Nerve Palsy Based on 49 Patients. World Neurosurg. 2018 Jul;115:e501-e508. doi: 10.1016/j.wneu.2018.04.078. Epub 2018 Apr 22.

  PMID: 29689396 BACKGROUND

• Yang H, Sun J, Shi J, Shi G, Guo Y, Yang Y. Anterior Controllable Antedisplacement Fusion (ACAF) for Severe Cervical Ossification of the Posterior Longitudinal Ligament: Comparison with Anterior Cervical Corpectomy with Fusion (ACCF). World Neurosurg. 2018 Jul;115:e428-e436. doi: 10.1016/j.wneu.2018.04.065. Epub 2018 Apr 17.

  PMID: 29678703 BACKGROUND

• Miao J, Sun J, Shi J, Chen Y, Chen D. A Novel Anterior Revision Surgery for the Treatment of Cervical Ossification of Posterior Longitudinal Ligament: Case Report and Review of the Literature. World Neurosurg. 2018 May;113:212-216. doi: 10.1016/j.wneu.2018.02.076. Epub 2018 Feb 21.

  PMID: 29476997 BACKGROUND

• Sun JC, Yang HS, Shi JG, Yuan W, Xu XM, Shi GD, Jia LS. Morphometric Analysis of the Uncinate Process as a Landmark for Anterior Controllable Antedisplacement and Fusion Surgery: A Study of Radiologic Anatomy. World Neurosurg. 2018 May;113:e101-e107. doi: 10.1016/j.wneu.2018.01.181. Epub 2018 Feb 5.

  PMID: 29421454 BACKGROUND

• Sun J, Shi J, Xu X, Yang Y, Wang Y, Kong Q, Yang H, Guo Y, Han D, Jiang J, Shi G, Yuan W, Jia L. Anterior controllable antidisplacement and fusion surgery for the treatment of multilevel severe ossification of the posterior longitudinal ligament with myelopathy: preliminary clinical results of a novel technique. Eur Spine J. 2018 Jun;27(6):1469-1478. doi: 10.1007/s00586-017-5437-4. Epub 2017 Dec 28.

  PMID: 29285560 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 MI: Last Name:

  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: June 6, 2018
• First Posted: July 19, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2023
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

CN (1)