A Multi-center Study：Comparison of ACAF and ACCF in the Treatment of Cervical OPLL (NCT03591692) | Clinical Trial Compass
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A Multi-center Study：Comparison of ACAF and ACCF in the Treatment of Cervical OPLL
China840 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range45 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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;
What they're measuring
1
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.
. 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;