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Ossification of Posterior Longitudinal LigamentNCT04968028

Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament

A study testing ACAF and Laminoplasty in people with Ossification of Posterior Longitudinal Ligament and Cervical Spondylosis With Myelopathy, run by Shanghai Changzheng Hospital at 12 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to compare the efficacy, safety and imaging outcomes between Anterior Controllable Antedisplacement and Fusion (ACAF) and Laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
ACAF and Laminoplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
12 sitesChina
Study dates
17 Aug 2021to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient's age is 18-70 years old, regardless of gender;
  • The patient was diagnosed as severe ossification of the posterior longitudinal ligament (X-ray or CT showed ossification of the posterior longitudinal ligament); The imaging findings showed occupied ratio ≥ 60% or involved three or more segments;
  • Symptoms of spinal cord and nerve root compression, or accompanied by spinal cord compression symptoms such as dysfunction of urination and defecation, conservative treatment was ineffective or aggravated gradually;
  • The participant (or his legal guardian) can sign the informed consent.

Who cannot join

  • Congenital malformations (including but not limited to occipitocervical malformations, congenital cervical fusion, cervical related neurovascular malformations), ossification of cervical ligamentum flavum, cervical trauma, cervical cancer, cervical tuberculosis and other inflammatory diseases;
  • Patients with other spinal diseases such as thoracolumbar vertebrae that affect clinical symptoms; Patients with motor neuron diseases such as amyotrophic lateral sclerosis and other nervous system diseases;
  • The symptoms were aggravated due to recent trauma;
  • Patients who participated in other clinical trials in recent 3 months;
  • The participant (or his legal guardian) with mental illness and cognitive impairment can not give full informed consent;
  • Those who are in poor health and can not tolerate surgery; The patients were not suitable for surgical treatment after preoperative examination.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjaing, 150086

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272100

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266555

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200003

  • The First Affiliated Hospital of Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200086

  • Shanghai Tongji Hospital, School of Medicine, Tongji University

    Shanghai, Shanghai Municipality, 200333

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • The Second Affiliated Hospital, Air Force Medical University

    Xi’an, Shanxi, 710000

Other trials in China

About this study

Official title: An Open-label Randomized Multi-centre Study to Evaluate Anterior Controllable Antedisplacement and Fusion Versus Posterior Laminoplasty in Patients With Cervical Ossification of the Posterior Longitudinal Ligament

The purpose of this study is to compare the efficacy, safety and imaging outcomes between Anterior Controllable Antedisplacement and Fusion (ACAF) and Laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament.

Read the detailed description

This is a national, multicenter, prospective, randomized controlled trial to compare the safety and efficacy of ACAF and posterior laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament. In this study, 164 adult patients aged 18-70 with severe copll were randomly assigned to the experimental group (using ACAF) and the control group (using lamp) according to the ratio of 1:1. The patients were followed up for 2 years.

Being tested
ACAF, Laminoplasty
Keywords
OPLL, Cervical Spondylotic Myelopathy, ACAF, Laminoplasty, Multicenter Study
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.

  • ACAFProcedure or surgery

    Also called Anterior Controllable Antedisplacement and Fusion

    (1)A standard right-side Smith-Robinson approach is performed. (2) The involved disc tissues are removed. The posterior longitudinal ligament is cut down at the levels cephalic and caudal to OPLL. (3) The anterior portion of the middle vertebral bodies is removed according to the thickness of ossification. Suitable cages are placed into each intervertebral space. (4) On the left side of the vertebra, a 2-mm-wide groove is created at the medial border of the transverse foramina. After that, an curved plated is fixed with screws. (5) On the right side of the vertebrae, a similar groove was also created. (6) Finally, tightening the screws to achieve a gradual evaluation of the vertebrae with OPLL.

  • LaminoplastyProcedure or surgery

    (1) In the prone position, the skin and nuchal ligament were cut through the posterior median incision, and the paravertebral muscles were stripped layer by layer to expose the bilateral vertebral lamina, lateral mass and articular process.（2) Part of spinous process were removed with bone biting forceps. The side with more severe symptoms was selected as the open side, bone groove was performed at 2-3 mm of the medial edge of bilateral facet joints with the medial cortex was reserved at the shaft side.（3) Slowly lift the lamina and maintained.（4)Determining the opening width of each segment by trial, and selecting the appropriate size Arch miniplate, and fixed with screws.

Study groups in NCT04968028
Study groupRoleWhat they receive
ACAFExperimentalParticipants underwent anterior decompression of Anterior Controllable Antedisplacement and Fusion
Receives: Procedure: ACAF
LaminoplastyExperimentalParticipants underwent posterior decompression of Laminoplasty
Receives: Procedure: Laminoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C-JOA Recovery Rate

    (postoperative JOA score at 3 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%

    Measured: Time point of outcome: 3 months post-operative follow-up visits

  2. C-JOA Recovery Rate

    (postoperative JOA score at 6 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%

    Measured: Time point of outcome: 6 months post-operative follow-up visits

  3. C-JOA Recovery Rate

    (postoperative JOA score at 12 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%

    Measured: Time point of outcome: 12 months post-operative follow-up visits

  4. C-JOA Recovery Rate

    (postoperative JOA score at 24 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%

    Measured: Time point of outcome: 24 months post-operative follow-up visits

Secondary outcomes (4)

  1. Japanese Orthopaedic Association Scores

    Filling in the Japanese Orthopaedic Association Scores scale. This scale involves four aspects: upper limb motor function (range, 0 to 4 points), lower limb motor function (range, 0 to 4 points), sensory function (range, 0 to 6 points), and bladder function (range, 0 to 3 points). The total C-JOA score ranged from 0 (worst) to 17 (normal condition).

    Measured: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits

  2. Visual Analogue Scale

    Filling in the Visual Analogue Scale pain score that range, 0 [no pain] to 10 [most severe].

    Measured: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits

  3. Neck Disability Index

    Filling in the 10-item Neck Disability Index scale that totally range 0 to 50 points, the highest index the worst.

    Measured: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits

  4. Nurick-Score

    Filling in the 6-level Nurick disability grade scale that range 0 [mild] to 5 [severe].

    Measured: 28 days before operation and 3, 6, 12, 24 months 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.

  1. First posted20 Jul 2021
  2. Study start17 Aug 2021
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04968028
Sponsor's protocol ID
2021SL029
Status last verified
Jul 2025
First submitted
11 Jul 2021
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chen Y, Sun J, Yuan X, Guo Y, Yang H, Chen D, Shi J. Comparison of Anterior Controllable Antedisplacement and Fusion With Posterior Laminoplasty in the Treatment of Multilevel Cervical Ossification of the Posterior Longitudinal Ligament: A Prospective, Randomized, and Control Study With at Least 1-Year Follow Up. Spine (Phila Pa 1976). 2020 Aug 15;45(16):1091-1101. doi: 10.1097/BRS.0000000000003462.

    PubMed 32097261

  • Sun K, Wang S, Huan L, Sun J, Xu X, Sun X, Shi J, Guo Y. Analysis of the spinal cord angle for severe cervical ossification of the posterior longitudinal ligament: comparison between anterior controllable antedisplacement and fusion (ACAF) and posterior laminectomy. Eur Spine J. 2020 May;29(5):1001-1012. doi: 10.1007/s00586-019-06216-6. Epub 2019 Dec 3.

    PubMed 31797138

  • Chen Y, Sun J, Han D, Yuan X, Wang Y, Guo Y, Zhong X, Shi J. An open-label randomized multi-Centre study to evaluate anterior controllable Antedisplacement and fusion versus posterior Laminoplasty in patients with cervical ossification of the posterior longitudinal ligament: study design and analysis plan (STAR). BMC Musculoskelet Disord. 2021 Sep 8;22(1):765. doi: 10.1186/s12891-021-04645-3.

    PubMed 34496821

Questions about this trial

What is this clinical trial studying?

A study testing ACAF and Laminoplasty in people with Ossification of Posterior Longitudinal Ligament and Cervical Spondylosis With Myelopathy, run by Shanghai Changzheng Hospital at 12 sites 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 6 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

C-JOA Recovery Rate (time frame: Time point of outcome: 3 months post-operative follow-up visits). The study lists 4 primary outcomes in all. 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 NCT04968028, which also lists 3 linked publications.

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 13 May 2026.

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