Scheuermann's KyphosisNCT05953792
Selecting the SSV-1 as LIV in Scheuermann's Kyphosis
An observational study of Scheuermann's Kyphosis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
The proper selection of the lowest instrumented vertebra (LIV) remains controversial in the surgical treatment of Scheuermann's disease and there is a paucity of studies investigating the clinical outcomes of fusion surgery when selecting the vertebra one level proximal to the sagittal stable vertebra (SSV-1) as LIV. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Scheuermann's Kyphosis
- What is being tested?
- Select the vertebra above sagittal stable vertebra as the distal fusion level
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2022
- 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 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A total of 36 SK patients (including 23 with TK and 13 patients with TLK) were included in this study, among which 29 were male, and 7 were female.
Who may be able to join
- diagnosis of SK patients;
- underwent one-stage posterior spinal fusion (PSF) with multi-level Ponte osteotomies;
- selecting SSV-1 as LIV;
- with a minimum follow-up of 2 years.
Who cannot join
- with previous spinal surgical history;
- with any other spinal deformities;
- without complete follow-up data.
Trial locations and contacts
1 site in 1 country.
China1 site
Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
About this study
Official title: Selecting the Vertebra Above Sagittal Stable Vertebra as the Distal Fusion Level in Scheuermann's Kyphosis
The proper selection of the lowest instrumented vertebra (LIV) remains controversial in the surgical treatment of Scheuermann's disease and there is a paucity of studies investigating the clinical outcomes of fusion surgery when selecting the vertebra one level proximal to the sagittal stable vertebra (SSV-1) as LIV. The purpose of this study is to investigate whether SSV-1 could be a valid LIV for Scheuermann kyphosis (SK) patients with different curve patterns.
Read the detailed description
The proper selection of the lowest instrumented vertebra (LIV) remains controversial in the surgical treatment of Scheuermann's disease and there is a paucity of studies investigating the clinical outcomes of fusion surgery when selecting the vertebra one level proximal to the sagittal stable vertebra (SSV-1) as LIV. The purpose of this study is to investigate whether SSV-1 could be a valid LIV for Scheuermann kyphosis (SK) patients with different curve patterns.
This was a prospective study on consecutive SK patients treated with posterior surgery between January 2018 and September 2020, in which the distal fusion level ended at SSV-1. The LIV was selected at SSV-1 only in patients with Risser > 2 and with LIV translation less than 40mm. All of the patients had a minimum of 2-year follow-up. Patients were further grouped based on the sagittal curve pattern as thoracic kyphosis (TK) and thoracolumbar kyphosis (TLK). Radiographic parameters including global kyphosis (GK), lumbar lordosis (LL), sagittal vertical axis (SVA), LIV translation, pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS) were measured preoperatively, postoperatively and at the latest follow-up. The intraoperative and postoperative complications were recorded. The Scoliosis Research Society (SRS)-22 scores were performed to evaluate clinical outcomes.
- Conditions
- Scheuermann's Kyphosis
- Being tested
- Select the vertebra above sagittal stable vertebra as the distal fusion level
- Medical subject headings
- Scheuermann Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Select the vertebra above sagittal stable vertebra as the distal fusion levelProcedure or surgery
The surgeries were performed by the same surgical team. Multi-level Ponte osteotomies were performed across the apex of the kyphosis after complete exposure of the spine, with resection of supra- and inter-spinous ligaments, ligamentum flavum, and the whole facet joints. After placement of the pedicle screws at the expected fusion levels, pre-contoured rods were attached to the screws followed by segmental compression. During rod placement, two to three rounds of compression in the area with Ponte osteotomies were employed to enhance kyphosis correction. Satellite rods were routinely added to long rods and implanted with duet screws. The final tightening was performed, and the posterior fusion was completed with a mixture of local and allogeneic bone. Due attention was given to preserving the posterior ligamentous structures at the upper and lower junctional areas.
| Study group | Role | What they receive |
|---|---|---|
| thoracic kyphosis | patients with their kyphotic apex located at T10 or above Receives: Procedure: Select the vertebra above sagittal stable vertebra as the distal fusion level | |
| thoracolumbar kyphosis | patients with their kyphotic apex located below T10 Receives: Procedure: Select the vertebra above sagittal stable vertebra as the distal fusion level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global kyphosis (GK) in degrees
Measured on anteroposterior and lateral radiographs and defined as the angle from upper to lower most tilted end vertebrae.
Measured: 24 months
Lumbar lordosis (LL) in degrees
Measured on anteroposterior and lateral radiographs and defined as the angle between the the superior end plate of L1 and S1
Measured: 24 months
Sagittal vertical axis (SVA) in millimeters
Measured on anteroposterior and lateral radiographs and defined as the horizontal distance between C7PL and the posterior superior corner of sacrum.
Measured: 24 months
Secondary outcomes (2)
Rates of distal junctional kyphosis
record the incidence of the distal junctional kyphosis at the last follow-up. Distal junctional kyphosis was defined as a distal junctional angle ≥10˚, or a distal junctional angle ≥ 10˚ than the preoperative measurement
Measured: 24 months
Scoliosis Research Society (SRS)-22 questionnaire
The Scoliosis Research Society (SRS)-22 questionnaire is adopted to assess the patient-reported outcomes. The overall score can range from 22 to 110 points, and higher scores reflect better health status.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Jan 2018
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scheuermann's KyphosisStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953792
- Sponsor's protocol ID
- 2021-LCYJ-DBZ-05
- Status last verified
- Jul 2023
- First submitted
- 2 Jul 2023
- Last updated
- 20 Jul 2023
- Results posted
- 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selecting the Vertebra Above Sagittal Stable Vertebra as the Distal Fusion Level in Scheuermann's Kyphosis
- ClinicalTrials.gov ID
- NCT05953792
- Acronym / sponsor ID
- 2021-LCYJ-DBZ-05
- Conditions
- Scheuermann's Kyphosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Jul 2023 (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 proper selection of the lowest instrumented vertebra (LIV) remains controversial in the surgical treatment of Scheuermann's disease and there is a paucity of studies investigating the clinical outcomes of fusion surgery when selecting the vertebra one level proximal to the sagittal stable vertebra (SSV-1) as LIV. The purpose of this study is to investigate whether SSV-1 could be a valid LIV for Scheuermann kyphosis (SK) patients with different curve patterns.
Detailed description
The proper selection of the lowest instrumented vertebra (LIV) remains controversial in the surgical treatment of Scheuermann's disease and there is a paucity of studies investigating the clinical outcomes of fusion surgery when selecting the vertebra one level proximal to the sagittal stable vertebra (SSV-1) as LIV. The purpose of this study is to investigate whether SSV-1 could be a valid LIV for Scheuermann kyphosis (SK) patients with different curve patterns.
This was a prospective study on consecutive SK patients treated with posterior surgery between January 2018 and September 2020, in which the distal fusion level ended at SSV-1. The LIV was selected at SSV-1 only in patients with Risser > 2 and with LIV translation less than 40mm. All of the patients had a minimum of 2-year follow-up. Patients were further grouped based on the sagittal curve pattern as thoracic kyphosis (TK) and thoracolumbar kyphosis (TLK). Radiographic parameters including global kyphosis (GK), lumbar lordosis (LL), sagittal vertical axis (SVA), LIV translation, pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS) were measured preoperatively, postoperatively and at the latest follow-up. The intraoperative and postoperative complications were recorded. The Scoliosis Research Society (SRS)-22 scores were performed to evaluate clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thoracic kyphosis | – | Procedure: Select the vertebra above sagittal stable vertebra as the distal fusion levelpatients with their kyphotic apex located at T10 or above |
| thoracolumbar kyphosis | – | Procedure: Select the vertebra above sagittal stable vertebra as the distal fusion levelpatients with their kyphotic apex located below T10 |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A total of 36 SK patients (including 23 with TK and 13 patients with TLK) were included in this study, among which 29 were male, and 7 were female.
Key inclusion criteria (4 listed)
- diagnosis of SK patients;
- underwent one-stage posterior spinal fusion (PSF) with multi-level Ponte osteotomies;
- selecting SSV-1 as LIV;
- with a minimum follow-up of 2 years.
Key exclusion criteria (3 listed)
- with previous spinal surgical history;
- with any other spinal deformities;
- without complete follow-up data.
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 |
|---|---|---|
| Select the vertebra above sagittal stable vertebra as the distal fusion levelThe surgeries were performed by the same surgical team. Multi-level Ponte osteotomies were performed across the apex of the kyphosis after complete exposure of the spine, with resection of supra- and inter-spinous ligaments, ligamentum flavum, and the whole facet joints. After placement of the pedicle screws at the expected fusion levels, pre-contoured rods were attached to the screws followed by segmental compression. During rod placement, two to three rounds of compression in the area with Ponte osteotomies were employed to enhance kyphosis correction. Satellite rods were routinely added to long rods and implanted with duet screws. The final tightening was performed, and the posterior fusion was completed with a mixture of local and allogeneic bone. Due attention was given to preserving the posterior ligamentous structures at the upper and lower junctional areas. | Procedure or surgery | thoracic kyphosis, thoracolumbar kyphosis |
Primary outcome
Global kyphosis (GK) in degrees
Time frame: 24 months
Measured on anteroposterior and lateral radiographs and defined as the angle from upper to lower most tilted end vertebrae.
Lumbar lordosis (LL) in degrees
Time frame: 24 months
Measured on anteroposterior and lateral radiographs and defined as the angle between the the superior end plate of L1 and S1
Sagittal vertical axis (SVA) in millimeters
Time frame: 24 months
Measured on anteroposterior and lateral radiographs and defined as the horizontal distance between C7PL and the posterior superior corner of sacrum.
2 secondary outcomes
Rates of distal junctional kyphosis
Time frame: 24 months
Scoliosis Research Society (SRS)-22 questionnaire
Time frame: 24 months
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 20 Jul 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Scheuermann's Kyphosis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 4 inclusion and 3 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 20 Jul 2023. 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?
Global kyphosis (GK) in degrees (time frame: 24 months). The study lists 3 primary outcomes in all. 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 20 Jul 2023.