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

May 8, 2026 updated by: Shanghai Changzheng Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
167

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Xuanwu Hospital Capital Medical University
    • Guangdong
      • Shenzhen, Guangdong, China, 518036
        • Peking University Shenzhen Hospital
    • Heilongjaing
      • Harbin, Heilongjaing, China, 150086
        • The 2nd Affiliated Hospital of Harbin Medical University
    • Shandong
      • Jining, Shandong, China, 272100
        • Affiliated Hospital of Jining Medical University
      • Qingdao, Shandong, China, 266555
        • The Affiliated Hospital of Qingdao University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200003
        • Shanghai Changzheng Hospital
      • Shanghai, Shanghai Municipality, China, 200433
        • Shanghai Changhai Hospital
      • Shanghai, Shanghai Municipality, China, 200003
        • Shanghai Sixth People's Hospital
      • Shanghai, Shanghai Municipality, China, 200086
        • The First Affiliated Hospital of Shanghai Jiao Tong University
      • Shanghai, Shanghai Municipality, China, 200333
        • Shanghai Tongji Hospital, School of Medicine, Tongji University
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Shanxi Bethune Hospital
      • Xi’an, Shanxi, China, 710000
        • The Second Affiliated Hospital, Air Force Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The patient's age is 18-70 years old, regardless of gender;
  2. 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;
  3. 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;
  4. The participant (or his legal guardian) can sign the informed consent.

Exclusion Criteria:

  1. 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;
  2. 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;
  3. The symptoms were aggravated due to recent trauma;
  4. Patients who participated in other clinical trials in recent 3 months;
  5. The participant (or his legal guardian) with mental illness and cognitive impairment can not give full informed consent;
  6. Those who are in poor health and can not tolerate surgery; The patients were not suitable for surgical treatment after preoperative examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACAF
Participants underwent anterior decompression of Anterior Controllable Antedisplacement and Fusion
Procedure: ACAF
(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.
Other Names:
  • Anterior Controllable Antedisplacement and Fusion
Experimental: Laminoplasty
Participants underwent posterior decompression of Laminoplasty
Procedure: Laminoplasty
(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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
C-JOA Recovery Rate
Time Frame: Time point of outcome: 3 months post-operative follow-up visits
(postoperative JOA score at 3 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%
Time point of outcome: 3 months post-operative follow-up visits
C-JOA Recovery Rate
Time Frame: Time point of outcome: 6 months post-operative follow-up visits
(postoperative JOA score at 6 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%
Time point of outcome: 6 months post-operative follow-up visits
C-JOA Recovery Rate
Time Frame: Time point of outcome: 12 months post-operative follow-up visits
(postoperative JOA score at 12 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%
Time point of outcome: 12 months post-operative follow-up visits
C-JOA Recovery Rate
Time Frame: Time point of outcome: 24 months post-operative follow-up visits
(postoperative JOA score at 24 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)* 100%
Time point of outcome: 24 months post-operative follow-up visits

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Japanese Orthopaedic Association Scores
Time Frame: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
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).
28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Visual Analogue Scale
Time Frame: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Filling in the Visual Analogue Scale pain score that range, 0 [no pain] to 10 [most severe].
28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Neck Disability Index
Time Frame: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Filling in the 10-item Neck Disability Index scale that totally range 0 to 50 points, the highest index the worst.
28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Nurick-Score
Time Frame: 28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Filling in the 6-level Nurick disability grade scale that range 0 [mild] to 5 [severe].
28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Changzheng Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Changhai Hospital
Tongji Hospital
The Affiliated Hospital of Qingdao University
Xuanwu Hospital, Beijing
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Tang-Du Hospital
Peking University Shenzhen Hospital
The Second Affiliated Hospital of Harbin Medical University
Shanghai 6th People's Hospital
Shanxi Bethune Hospital
Affiliated Hospital of Jining Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jiangang Shi, Doctor, Shanghai Changzheng Hospital
  • Study Director: Dan Han, Master, Shanghai Changzheng Hospital
  • Principal Investigator: Yu Chen, Doctor, Shanghai Changzheng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021SL029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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