Ossification of the Posterior Longitudinal LigamentNCT05019001
A Prospective Study Comparing the Efficacy of Laminoplasty and Laminectomy With Fusion for Ossification of the Posterior Longitudinal Ligament With High Occupation Rate in Cervical Spine
A study testing Laminoplasty and Laminectomy With Fusion in people with Ossification of the Posterior Longitudinal Ligament, run by Peking University Third Hospital at 1 site in China.
Trial summary
The efficacy of laminoplasty and laminectomy with fusion for ossification of the posterior longitudinal ligament with high occupation rate in the cervical spine is not clear in the literature report so far. This study is designed to further research the difference in efficacy between the two surgical methods. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ossification of the Posterior Longitudinal Ligament
- What is being tested?
- Laminoplasty and Laminectomy With Fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 28 Feb 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed by clinical symptoms, physical examination, X-ray, CT, and MRI with a high occupation rate of ossification of the posterior longitudinal ligament in the cervical spine need and can be treated surgically after preoperative examination.
- CT axial soft tissue window determine that the occupation rate of one or more spinal canal segments in C2-7 is more than 60%.
- Sagittal CT show ossification of more than 3 segments of the posterior longitudinal ligament of the cervical spine.
- Sign the written informed consent
Who cannot join
- Participating in other interventional clinical trials;
- Mental disorders or cognitive disorders;
- Heart and lung diseases;
- Nervous system diseases;
- Patients with serious liver and kidney diseases, tumors and infectious diseases;
- There are any other factors that the treated doctors consider unsuitable for inclusion or completion of the study.
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- Patients with cervical spondylotic radiculopathy
- Patients with severe osteoporosis, skeletal fluorosis and other reasons for which laminoplasty is not feasible
- Patients with ossification of posterior longitudinal ligament of cervical spine with invasion rate ≥60% had cervical trauma
- The patient with cervical ligamentum flavum ossification was diagnosed at the C2-7 level
- Preoperative pregnancy test was performed to exclude pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
The efficacy of laminoplasty and laminectomy with fusion for ossification of the posterior longitudinal ligament with high occupation rate in the cervical spine is not clear in the literature report so far. This study is designed to further research the difference in efficacy between the two surgical methods.
Read the detailed description
Ossification of the posterior longitudinal ligament(OPLL) is a common spinal disease which can lead to neurological dysfunction and its morbidity is related to genetic factors. OPLL is usually found in cervical spine and characterized by hypertrophy and ossification of the posterior longitudinal ligament in the rear of the corresponding cervical vertebral body, which can encroach the space in the spinal canal and compress the spinal cord and/or nerve roots of the corresponding segments, resulting in sensory and motor disorders of the limbs as well as visceral autonomic nervous dysfunction, leading to neurological dysfunction and even high paraplegia. It not only causes great harm but also brings heavy economic and spiritual burden to patients and society.
Although the surgical treatments for OPLL include anterior and posterior approach, the anterior approach requires excellent equipment and rich operation experience for surgery doctor. Many articles showed significantly higher complications rate in anterior approach than that of posterior approach. Posterior approach surgery is considered to be one of the effective treatment methods for OPLL in cervical spine. In the posterior approach, there are two commonly recognized surgical procedures, laminoplasty and laminectomy with fusion. The efficacy of laminoplasty and laminectomy with fusion for ossification of the posterior longitudinal ligament with high occupation rate in the cervical spine is not clear in the literature report so far. This study is designed to further research the difference in efficacy between the two surgical methods. The purpose of this study is to make patients get the biggest medical benefits and to make a right surgical treatment strategy when doctors treating patients with high occupation rate OPLL in cervical spine.
- Being tested
- Laminoplasty, Laminectomy With Fusion
- Keywords
- OPLL, high occupation rate, laminoplasty, laminectomy with fusion
- 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.
LaminoplastyProcedure or surgery
A posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament
Laminectomy With FusionProcedure or surgery
Another posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament
| Study group | Role | What they receive |
|---|---|---|
| Laminoplasty | Other | A posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament Receives: Procedure: Laminoplasty |
| Laminectomy With Fusion | Other | Another posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament Receives: Procedure: Laminectomy With Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative mJOA score
Preoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
Measured: preoperative
postoperative mJOA score
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
Measured: postoperative at 3 months
postoperative mJOA score
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
Measured: postoperative at 6 months
postoperative mJOA score
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
Measured: postoperative at 1 year
postoperative mJOA score
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
Measured: postoperative at 2 year
mJOA score change rate
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
Measured: 3 months after surgery
mJOA score change rate
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
Measured: 6 months after surgery
mJOA score change rate
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
Measured: 1 year after surgery
mJOA score change rate
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
Measured: 2 years after surgery
Secondary outcomes (14)
Operation time
Operation time during operation
Measured: during operation
blood loss
blood loss during operation, parameter is milliliter, which is caculated by anesthetist during operation
Measured: during operation
Rate of C5 nerve root palsy
Whether patient has deltoid muscle strength decrease after operation. If there is, it means to appear C5 palsy.
Measured: C5 nerve palsy after operation immediately
hematoma incidence
hematoma after operation
Measured: hematoma after operation immediately
Rate of spinal cord injury
Whether patient has spinal cord injury after operation. If there is, it means to appear sensory and motor impairments of limbs and trunk.
Measured: spinal cord injury after operation immediately
range of motion
the movement range of cervical
Measured: preoperation
range of motion
the movement range of cervical
Measured: 3 months after surgery
range of motion
the movement range of cervical
Measured: 6 months after surgery
range of motion
the movement range of cervical
Measured: 1 year after surgery
range of motion
the movement range of cervical
Measured: 2 years after surgery
neck pain VAS score
Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
Measured: 3 months after surgery
neck pain VAS score
Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
Measured: 6 months after surgery
neck pain VAS score
Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
Measured: 1 year after surgery
neck pain VAS score
Visual Analog Score for pain of neck, range from 0-10, a higher score means more pain
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Mar 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ossification of the Posterior Longitudinal LigamentStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Chen, Dr., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019001
- Sponsor's protocol ID
- ChenxinPekingUTH
- Status last verified
- Jun 2021
- First submitted
- 20 Jun 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing the Efficacy of Laminoplasty and Laminectomy With Fusion for Ossification of the Posterior Longitudinal Ligament With High Occupation Rate in Cervical Spine
- ClinicalTrials.gov ID
- NCT05019001
- Acronym / sponsor ID
- ChenxinPekingUTH
- Keywords
- OPLL, high occupation rate, laminoplasty, laminectomy with fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 24 Aug 2021 (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.
The efficacy of laminoplasty and laminectomy with fusion for ossification of the posterior longitudinal ligament with high occupation rate in the cervical spine is not clear in the literature report so far. This study is designed to further research the difference in efficacy between the two surgical methods.
Detailed description
Ossification of the posterior longitudinal ligament(OPLL) is a common spinal disease which can lead to neurological dysfunction and its morbidity is related to genetic factors. OPLL is usually found in cervical spine and characterized by hypertrophy and ossification of the posterior longitudinal ligament in the rear of the corresponding cervical vertebral body, which can encroach the space in the spinal canal and compress the spinal cord and/or nerve roots of the corresponding segments, resulting in sensory and motor disorders of the limbs as well as visceral autonomic nervous dysfunction, leading to neurological dysfunction and even high paraplegia. It not only causes great harm but also brings heavy economic and spiritual burden to patients and society.
Although the surgical treatments for OPLL include anterior and posterior approach, the anterior approach requires excellent equipment and rich operation experience for surgery doctor. Many articles showed significantly higher complications rate in anterior approach than that of posterior approach. Posterior approach surgery is considered to be one of the effective treatment methods for OPLL in cervical spine. In the posterior approach, there are two commonly recognized surgical procedures, laminoplasty and laminectomy with fusion. The efficacy of laminoplasty and laminectomy with fusion for ossification of the posterior longitudinal ligament with high occupation rate in the cervical spine is not clear in the literature report so far. This study is designed to further research the difference in efficacy between the two surgical methods. The purpose of this study is to make patients get the biggest medical benefits and to make a right surgical treatment strategy when doctors treating patients with high occupation rate OPLL in cervical spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laminoplasty | Other | Procedure: LaminoplastyA posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament |
| Laminectomy With Fusion | Other | Procedure: Laminectomy With FusionAnother posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed by clinical symptoms, physical examination, X-ray, CT, and MRI with a high occupation rate of ossification of the posterior longitudinal ligament in the cervical spine need and can be treated surgically after preoperative examination.
- CT axial soft tissue window determine that the occupation rate of one or more spinal canal segments in C2-7 is more than 60%.
- Sagittal CT show ossification of more than 3 segments of the posterior longitudinal ligament of the cervical spine.
- Sign the written informed consent
Key exclusion criteria (11 listed)
- Participating in other interventional clinical trials;
- Mental disorders or cognitive disorders;
- Heart and lung diseases;
- Nervous system diseases;
- Patients with serious liver and kidney diseases, tumors and infectious diseases;
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 |
|---|---|---|
| LaminoplastyA posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament | Procedure or surgery | Laminoplasty |
| Laminectomy With FusionAnother posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament | Procedure or surgery | Laminectomy With Fusion |
Primary outcome
preoperative mJOA score
Time frame: preoperative
Preoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
postoperative mJOA score
Time frame: postoperative at 3 months
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
postoperative mJOA score
Time frame: postoperative at 6 months
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
postoperative mJOA score
Time frame: postoperative at 1 year
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
postoperative mJOA score
Time frame: postoperative at 2 year
Postoperative mJOA score, range from 0 to 17. The higher the score, the less severe the symptoms
mJOA score change rate
Time frame: 3 months after surgery
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
mJOA score change rate
Time frame: 6 months after surgery
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
mJOA score change rate
Time frame: 1 year after surgery
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
mJOA score change rate
Time frame: 2 years after surgery
(Postoperative mJOA score-Preoperative mJOA score)/(17-Preoperative mJOA score)×100%
14 secondary outcomes
Operation time
Time frame: during operation
blood loss
Time frame: during operation
Rate of C5 nerve root palsy
Time frame: C5 nerve palsy after operation immediately
hematoma incidence
Time frame: hematoma after operation immediately
Rate of spinal cord injury
Time frame: spinal cord injury after operation immediately
range of motion
Time frame: preoperation
range of motion
Time frame: 3 months after surgery
range of motion
Time frame: 6 months after surgery
range of motion
Time frame: 1 year after surgery
range of motion
Time frame: 2 years after surgery
neck pain VAS score
Time frame: 3 months after surgery
neck pain VAS score
Time frame: 6 months after surgery
neck pain VAS score
Time frame: 1 year after surgery
neck pain VAS score
Time frame: 2 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Ossification of the 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.
Xin Chen, Dr. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laminoplasty and Laminectomy With Fusion in people with Ossification of the Posterior Longitudinal Ligament, run by Peking University Third 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 24 Aug 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
preoperative mJOA score (time frame: preoperative). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2021.