Ossification of Posterior Longitudinal LigamentACAFNCT03312985
Comparison of ACAF and ACCF in the Treatment of Cervical OPLL
A study testing ACAF surgery and ACCF surgery in people with Ossification of Posterior Longitudinal Ligament, run by Shanghai Changzheng Hospital at 1 site in China.
Trial 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）. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Ossification of Posterior Longitudinal Ligament
- What is being tested?
- ACAF surgery and ACCF surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200001
About this study
Official title: Comparison of Anterior Cervical Anteriodisplacement Fusion and Corpectomy Decompression Fusion in Treatment of Ossification of the Posterior Longitudinal Ligament: A Conservative Treatment- Controlled, Randomized, Open Label Clinical Study
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.
Read the 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.
- Being tested
- ACAF surgery, ACCF surgery
- Medical subject headings
- Ossification of Posterior Longitudinal Ligament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACAF surgeryProcedure or 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
ACCF surgeryProcedure or surgery
Removal of the vertebral body，exposed ossification of the posterior longitudinal ligament，and then removed
| Study group | Role | What they receive |
|---|---|---|
| ACAF surgery | Experimental | Underwent anterior controllable antedisplacement and fusion Receives: Procedure: ACAF surgery |
| ACCF surgery | Placebo comparator | Underwentanterior controllable antedisplacement and fusion Receives: Procedure: ACCF surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
NURIC Graded presented by NURIC in 1972 used to assess improvement of Walking function。s divided into 6 levels, 0 - Although there are symptoms, but not based on the basis of spinal cord involvement (no limb numbness, decreased muscle strength and other symptoms); Grade 1 - spinal cord involvement (numbness of the limbs, decreased muscle strength and other symptoms), but normal gait; Level 2 ---- mild gait abnormalities, does not affect the work; Level 3 ---- abnormal gait, affecting work; Level 4 ---- Need to support before walking; Level 5 ---- can not walk.
Measured: 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
Visual Analogue Scale/Score（VAS） score used to assess improvement of pain.This method is more sensitive and comparable. Draw a 10 cm horizontal line on the paper, one end of the horizontal line is 0, said no pain; the other end of 10, said the pain; the middle part of the pain of varying degrees.
Measured: 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
Neck Disabilitv Index（NDI) used to assess improvement of Quality of life and cervical function.Clinical assessment of cervical function is commonly used, the scale includes the degree of pain, personal food, carrying objects, reading, headache, attention, work, driving, sleep and entertainment in all aspects. Each 5 points, the total score from 0 points (barrier-free) to 50 points (completely paralyzed), the higher the score the heavier the dysfunction.
Measured: 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
radiological parameters used to assess assessing ossification and spinal cord forward distance.The results for the direct measurement of CT and MRI results, the minimum 0mm, the maximum 10mm, the greater the distance forward, indicating that the wider spinal canal, the better the spinal cord decompression, the better the surgical results.
Measured: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 May 2017
- Primary completion1 May 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ossification of Posterior Longitudinal LigamentStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiangang Shi, Shanghai Changzheng Hospital
- Investigators
- Jiangang Shi, Study chair, Shanghai Changzheng Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312985
- Sponsor's protocol ID
- CZ1707OPLL
- Acronym
- ACAF
- Status last verified
- Nov 2017
- First submitted
- 13 Oct 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25000183
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anterior Cervical Anteriodisplacement Fusion and Corpectomy Decompression Fusion in Treatment of Ossification of the Posterior Longitudinal Ligament: A Conservative Treatment- Controlled, Randomized, Open Label Clinical Study
- ClinicalTrials.gov ID
- NCT03312985
- Acronym / sponsor ID
- ACAF / CZ1707OPLL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACAF surgery | Experimental | Procedure: ACAF surgeryUnderwent anterior controllable antedisplacement and fusion |
| ACCF surgery | Placebo comparator | Procedure: ACCF surgeryUnderwentanterior controllable antedisplacement and fusion |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACAF surgeryThe 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 | Procedure or surgery | ACAF surgery |
| ACCF surgeryRemoval of the vertebral body，exposed ossification of the posterior longitudinal ligament，and then removed | Procedure or surgery | ACCF surgery |
Primary outcome
Changes of patient-reported scores assessing improvement of spinal cord function underwent ACAF surgery compared to ACCF surgery
Time frame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
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.
4 secondary outcomes
Changes of patient-reported scores assessing improvement of Walking function underwent ACAF surgery compared to ACCF surgery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Background: PubMed 25000183Chen 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.
- Individual participant dataSharing planned: Undecided
Related trials for Ossification of Posterior Longitudinal Ligament
Active, not recruiting
Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament
Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiangang Shi study chair
Shanghai Changzheng Hospital, Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACAF surgery and ACCF surgery in people with Ossification of Posterior Longitudinal Ligament, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of patient-reported scores assessing improvement of spinal cord function underwent ACAF surgery compared to ACCF surgery (time frame: At 1 week pre- and 1, 12, 24, 48,96，240 weeks post-operative follow-up visits.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03312985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.