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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04910737
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 9.8
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Indications and Effectiveness for Extended Posterior Circumferential Decompression	Procedure: extended posterior circumferential decompressive surgery

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 Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Safety and Effectiveness of Extended Circumferential Decompression for Thoracic Ossification of Posterior Longitudinal Ligament：a Single-center Experience
• Actual Study Start Date: Jun 8, 2020
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Apr 1, 2021

Outcome Measures

Primary Outcome Measures

1. A modified Japanese Orthopedic Association Score [2 years]

   Spinal neurological function evaluation by Japanese Orthopedic Association

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second affiliated hospital of Zhejiang University, School of medicine	Hangzhou	Zhejiang	China	[phone]

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

• Study Director: Ruofu Tang, Second affiliated hospital of medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04910737
• Other Study ID Numbers: 2020-439
• First Posted: Jun 2, 2021
• Last Update Posted: Jun 2, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University: circumferential decompression; thoracic ossification of posterior longitudinal ligament; kyphosis; neurological outcomes
• Additional relevant MeSH terms: Ossification of Posterior Longitudinal Ligament

Study Results

No Results Posted as of Jun 2, 2021