Safety and Effectiveness of Extended Circumferential Decompression for Thoracic Ossification of Posterior Longitudinal Ligament

NCT ID: NCT04910737

Last Updated: 2021-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-08

Study Completion Date

2021-04-01

Brief Summary

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The study was to evaluate the indications, efficiency and safety of the extended posterior circumferential decompression technique for the treatment of thoracic ossification of posterior longitudinal ligament (TOPLL) with dura adhesions or ossification.

Detailed Description

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The clinical characteristics of patients with TOPLL combined with dura adhesions who underwent extended circumferential decompression in our hospital were retrospectively investigated. TOPLL adhered with dura matter or dura ossification were detected intraoperatively in all the cases. Imaging evaluation included the ossification-kyphosis angle and the fixed-segment kyphosis angle. A modified Japanese Orthopedic Association Score (JOA score) was applied for the evaluation of clinical outcomes.

Conditions

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Indications and Effectiveness for Extended Posterior Circumferential Decompression

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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extended posterior circumferential decompressive surgery

After the pedicle screws were implanted, laminectomy was performed. Kyphotic correction was done through a temporary rod to reduce the tension of spinal cord. The posterior 1/3 of the vertebral body was resected using a high-speed drill, preserving the anterior wall of the spinal canal to protect the cord from disturbance. The dissection of adhesion at the anterior side of spinal cord was to be done through a posterolateral direction. The region of posterior resection was expanded, including bilateral residual articular processes, transverse processes and pedicles. Slightly press down the ossified lesion, and detach it from the dura mater (perform a sharp dissection if necessary) followed by completely removal. If cerebrospinal fluid leakage was encountered during the process, autologous fat, fascia or gelatin sponge can be applied locally for packaging.

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

(1) spinal deformities; (2) thoracic spine fractures; (3) syringomyelia, spinal tumor, myelitis, etc.; (4) coexisted with cervical spondylosis and lumbar stenosis; (5) post operation of thoracic spinal stenosis; (6) recurrent myelopathy caused by lesions in other levels than the decompressed segments.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ruofu Tang

Role: STUDY_DIRECTOR

Second affiliated hospital of medicine, Zhejiang University

Locations

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Second affiliated hospital of Zhejiang University, School of medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2020-439

Identifier Type: -

Identifier Source: org_study_id

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