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NCT Number: NCT04968028

Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ossification of Posterior Longitudinal Ligament Bone Diseases Cervical Spondylosis With Myelopathy Musculoskeletal Diseases Ossification, Heterotopic Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

ACAF

Procedure

(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

Laminoplasty

Procedure

(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.

Primary outcomes

  1. 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%

  2. 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%

  3. 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%

  4. 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%

Secondary outcomes

  1. 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).

  2. 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].

  3. 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.

  4. 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].

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Collaborators

  • Affiliated Hospital of Jining Medical University
  • Changhai Hospital
  • Peking University Shenzhen Hospital
  • Shanghai 6th People's Hospital
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanxi Bethune Hospital
  • Tang-Du Hospital
  • The Affiliated Hospital of Qingdao University
  • The Second Affiliated Hospital of Harbin Medical University
  • Tongji Hospital
  • Xuanwu Hospital, Beijing

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2021
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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