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

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.

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Key information

Conditions

Indications and Effectiveness for Extended Posterior Circumferential Decompression Bone Diseases Kyphosis Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Second affiliated hospital of Zhejiang University, School of medicine

Hangzhou, Zhejiang, +86 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

extended posterior circumferential decompressive surgery

Procedure

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.

Primary outcomes

A modified Japanese Orthopedic Association Score

Time frame: 2 years

Spinal neurological function evaluation by Japanese Orthopedic Association

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Safety and Effectiveness of Extended Circumferential Decompression for Thoracic Ossification of Posterior Longitudinal Ligament：a Single-center Experience

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jun 2, 2021
Registry last updated: Jun 2, 2021

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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