Clinical trial NCT03591692: A Multi-center Study：Comparison of ACAF and ACCF in the Treatment of Cervical OPLL
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ossification of Posterior Longitudinal Ligament
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: Xuzhou No.1 Peoples Hospital
name: Jiangxi Provincial People's Hopital
name: No.102 Military Hospital of China Dormitory Area
name: Shanghai Kaiyuan Orthopedic Hospital
name: Huaibei Coal Mine General Hospital
First posted: 2018-07-19
Enrollment: 840
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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;
10. Vertebral length more than 3 intervertebral spaces.

Primary outcomes:
measure: Changes of patient-reported scores assessing improvement of spinal cord function underwent ACAF surgery compared to ACCF surgery
timeFrame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
Secondary outcomes:
measure: Changes of patient-reported scores assessing improvement of Walking function underwent ACAF surgery compared to ACCF surgery
timeFrame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
measure: Changes of patient-reported scores assessing improvement of pain underwent ACAF surgery compared to ACCF surgery
timeFrame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
measure: Changes of patient-reported scores assessing improvement of quality of life and cervical function underwent ACAF surgery compared to ACCF surgery
timeFrame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
measure: Changes of patient-reported scores assessing ossification and spinal cord forward distance underwent ACAF surgery compared to ACCF surgery
timeFrame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital, Second Military Medical University
name: Jiangang MI: Last Name:
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.