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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

167

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Shanghai Changzheng Hospital

Collaborators

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

  • 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)

August 17, 2021

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 11, 2021

First Submitted That Met QC Criteria

July 18, 2021

First Posted (Actual)

July 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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