Indications and Effectiveness for Extended Posterior Circumferential DecompressionNCT04910737
Safety and Effectiveness of Extended Circumferential Decompression for Thoracic Ossification of Posterior Longitudinal Ligament
An observational study of Indications and Effectiveness for Extended Posterior Circumferential Decompression, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Indications and Effectiveness for Extended Posterior Circumferential Decompression
- What is being tested?
- extended posterior circumferential decompressive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: No limit
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Second affiliated hospital of Zhejiang University, School of medicine
Hangzhou, Zhejiang, +86 310000
About this study
Official title: Safety and Effectiveness of Extended Circumferential Decompression for Thoracic Ossification of Posterior Longitudinal Ligament：a Single-center Experience
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.
Read the 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.
- Being tested
- extended posterior circumferential decompressive surgery
- Keywords
- circumferential decompression, thoracic ossification of posterior longitudinal ligament, kyphosis, neurological outcomes
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended posterior circumferential decompressive surgeryProcedure or 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
A modified Japanese Orthopedic Association Score
Spinal neurological function evaluation by Japanese Orthopedic Association
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start8 Jun 2020
- Primary completion1 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indications and Effectiveness for Extended Posterior Circumferential DecompressionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruofu Tang, Study director, Second affiliated hospital of medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910737
- Sponsor's protocol ID
- 2020-439
- Status last verified
- May 2021
- First submitted
- 28 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Extended Circumferential Decompression for Thoracic Ossification of Posterior Longitudinal Ligament：a Single-center Experience
- ClinicalTrials.gov ID
- NCT04910737
- Acronym / sponsor ID
- 2020-439
- Keywords
- circumferential decompression, thoracic ossification of posterior longitudinal ligament, kyphosis, neurological outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- No limit
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extended posterior circumferential decompressive surgeryAfter 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. | Procedure or surgery | – |
Primary outcome
A modified Japanese Orthopedic Association Score
Time frame: 2 years
Spinal neurological function evaluation by Japanese Orthopedic Association
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruofu Tang study director
Second affiliated hospital of medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indications and Effectiveness for Extended Posterior Circumferential Decompression, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A modified Japanese Orthopedic Association Score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.