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

NCT04968028 | Recruiting DMC

• 1 other identifier: 2021SL029
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Ossification of Posterior Longitudinal Ligament; Cervical Spondylosis With Myelopathy

Keywords

OPLL; Cervical Spondylotic Myelopathy; ACAF; Laminoplasty; Multicenter Study

Outcome Measures

Primary Outcomes (4)

• C-JOA Recovery Rate

  (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

  (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

  (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

  (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 Outcomes (4)

• Japanese Orthopaedic Association Scores

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

• Visual Analogue Scale

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

• Neck Disability Index

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

• Nurick-Score

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

Study Arms (2)

ACAF

EXPERIMENTAL

Participants underwent anterior decompression of Anterior Controllable Antedisplacement and Fusion

Procedure: ACAF

Laminoplasty

EXPERIMENTAL

Participants underwent posterior decompression of Laminoplasty

Procedure: Laminoplasty

Interventions

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.

Also known as: Anterior Controllable Antedisplacement and Fusion

ACAF

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.

Laminoplasty

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (12)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjaing, 150086, China

NOT YET RECRUITING

Xuanwu Hospital Capital Medical University

Beijing, Pekin, 100053, China

RECRUITING

Affiliated Hospital of Jining Medical University

Jining, Shandong, 272100, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266555, China

RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200003, China

NOT YET RECRUITING

The First Affiliated Hospital of Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200086, China

RECRUITING

Shanghai Tongji Hospital, School of Medicine, Tongji University

Shanghai, Shanghai Municipality, 200333, China

RECRUITING

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

NOT YET RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

RECRUITING

The Second Affiliated Hospital, Air Force Medical University

Xi’an, Shanxi, 710000, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 32097261 BACKGROUND

• 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.

  PMID: 31797138 BACKGROUND

• 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.

  PMID: 34496821 DERIVED

MeSH Terms

Conditions

Ossification of Posterior Longitudinal Ligament

Interventions

Gene Fusion; Laminoplasty

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ossification, Heterotopic; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena; Orthopedic Procedures; Therapeutics; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Jiangang Shi, Doctor

  Shanghai Changzheng Hospital

  STUDY CHAIR

• Dan Han, Master

  Shanghai Changzheng Hospital

  STUDY DIRECTOR

• Yu Chen, Doctor

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Han, Master

CONTACT

+86 18317028536; changzhengspine@163.com

Yu Chen, Doctor

CONTACT

+86 13916821845; cyspine@smmu.edu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In view of the obvious differences between the two surgery methods, this study was designed as an open-label trial. However, the results of X-ray, computed tomography (CT) and magnetic resonance imaging (MRI) will be independently reviewed by an independent radiographic review committee in a blind fashion in addition to the evaluation by site investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: July 20, 2021
• Study Start: August 17, 2021
• Primary Completion: July 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

CN (12)