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

Completed

• Conditions: Indications and Effectiveness for Extended Posterior Circumferential Decompression

• Registration Number: NCT04910737
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-06-08
• Primary Completion: 2021-03-01
• Study Completion: 2021-04-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Last Update Submitted: 2021-05-28
• Study First Posted: 2021-06-02
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

(1) thoracic myelopathy caused by TOPLL with or without TOLF; (2) severe adhesions between dura mater and ossified lesion with or without dura ossification confirmed intraoperatively; (3) extended posterior circumferential decompression was applied; (4) pedicle screw instrumentations were implanted after decompression; (5) follow-up for more than 6 months; (7) complete clinical data.

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A modified Japanese Orthopedic Association Score	2 years	Spinal neurological function evaluation by Japanese Orthopedic Association

Trial Locations

Locations (1)

Second affiliated hospital of Zhejiang University, School of medicine; 🇨🇳 Hangzhou, Zhejiang, China