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

Cervical Spondylosis With Myelopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04968028
• Other study ID #: 2021SL029
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Shanghai Changzheng Hospital
• Contact: Dan Han, Master
• Phone: +86 18317028536
• Email: changzhengspine[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: December 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Spondylosis With Myelopathy
• Ossification of Posterior Longitudinal Ligament
• Spinal Cord Diseases
• Spondylosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjaing
China	Affiliated Hospital of Jining Medical University	Jining	Shandong
China	Xuanwu Hospital Capital Medical University	Pekin	Pekin
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Shanghai Changhai Hospital	Shanghai	Shanghai
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
China	Shanghai Tongji Hospital, School of Medicine, Tongji University	Shanghai	Shanghai
China	The First Affiliated Hospital of Shanghai Jiao Tong University	Shanghai	Shanghai
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	The Second Affiliated Hospital, Air Force Medical University	Xi'an	Shanxi

Sponsors (12)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital	Changhai Hospital, Jining Medical University, 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

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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).	28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits
Secondary	Visual Analogue Scale	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
Secondary	Neck Disability Index	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
Secondary	Nurick-Score	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