ScoliosisNCT02388555
Perspective Analysis of Coronal Imbalance in Degenerative Scoliosis
An observational study of Scoliosis, run by Nanjing University School of Medicine.
Trial summary
Currently there is paucity of information on the prevalence of pre-operative coronal imbalance in patients with degenerative lumbar scoliosis (DLS) and its influence on surgical outcomes. Read more about this study
- Who is it for?
- Ages 50 to 82 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Posterior osteotomy correction
- Type of treatment
- Surgery or procedure
- How many people
- 284 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2015
- 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 50 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with degenerative scoliosis
Who may be able to join
- age > 50 years, diagnosis of DLS based on radiographies and previous medical history and Cobb angle >25°.
Who cannot join
- -
About this study
Official title: Coronal Imbalance in Degenerative Lumbar Scoliosis
Currently there is paucity of information on the prevalence of pre-operative coronal imbalance in patients with degenerative lumbar scoliosis (DLS) and its influence on surgical outcomes. This study aims to investigate in DLS, the prevalence of coronal imbalance, to propose a novel classification system and to investigate whether pre-operative coronal imbalance affects clinical outcomes following osteotomy. A total of 284 DLS patients were recruited.
Read the detailed description
A total of 284 DLS patients were recruited into this two-stage study, among which 69 patients were treated by posterior-only correction and the remaining 215 patients received conservative treatment. Using pre-operative long-cassette X-ray films, all patients were classified based on coronal balance distance (CBD) defined as the horizontal distance between C7 plumb line and central sacral vertical line: Type A, CBD < 3cm; Type B, CBD > 3cm and C7PL shifts to the concave side of curve; Type C, CBD > 3cm and C7PL shifts to the convex side of curve. The prevalence of pre-operative coronal imbalance was calculated for stage I study. Post-operative CBD in patients who received surgery was measured to evaluate clinical outcomes for stage II study.
- Conditions
- Scoliosis
- Being tested
- Posterior osteotomy correction
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior osteotomy correctionProcedure or surgery
The DLS patients underwent osteotomy including pedicle subtraction osteotomy (PSO) or Smith-Petersen osteotomy (SPO)
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative group | Respectively recruited patients with DLS. Patients in this group were not surgically treatment. Only pre-operative radiographic parameters were measured. | |
| Surgically treated group | All DLS patients received posterior osteotomy correction of spinal deformity. The immediate post-operative radiographic measurements were performed. Receives: Procedure: Posterior osteotomy correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between coronal balance classification and immediate post-operative imbalance using radiographic measurements
This part of the study aims to analyze the immediate imbalance after surgery, most of the patients took post-operative films two weeks after surgery, but there were some patients who could not stand at that timepoint and the follow-up time was then at 3 months after surgery.
Measured: Up to 3 months
Secondary outcomes (2)
Relationship between post-operative imbalance and quality of life using quality of life questionnaires including SF-36, ODI and VAS
The quality of life measurements were obtained using questionnaires, and the correlations between coronal imbalance and quality of life were analyzed at 1 year follow-up.
Measured: Up to 1 year
Prevalence of coronal imbalance in degenerative scoliosis using radiographic measurements
The prevalence of coronal imbalance was analyzed in this cross-sectional study. Only a small part of the patients were with longitudinal follow-up. Most of them were without follow-up.
Measured: Up to 2 year pre-operative follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJan 2010
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- 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
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongda Bao, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388555
- Sponsor's protocol ID
- 2013-079-01
- Status last verified
- Apr 2015
- First submitted
- 4 Feb 2015
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronal Imbalance in Degenerative Lumbar Scoliosis
- ClinicalTrials.gov ID
- NCT02388555
- Acronym / sponsor ID
- 2013-079-01
- Conditions
- Scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Mar 2015 (estimated)
- 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.
Currently there is paucity of information on the prevalence of pre-operative coronal imbalance in patients with degenerative lumbar scoliosis (DLS) and its influence on surgical outcomes. This study aims to investigate in DLS, the prevalence of coronal imbalance, to propose a novel classification system and to investigate whether pre-operative coronal imbalance affects clinical outcomes following osteotomy. A total of 284 DLS patients were recruited.
Detailed description
A total of 284 DLS patients were recruited into this two-stage study, among which 69 patients were treated by posterior-only correction and the remaining 215 patients received conservative treatment. Using pre-operative long-cassette X-ray films, all patients were classified based on coronal balance distance (CBD) defined as the horizontal distance between C7 plumb line and central sacral vertical line: Type A, CBD < 3cm; Type B, CBD > 3cm and C7PL shifts to the concave side of curve; Type C, CBD > 3cm and C7PL shifts to the convex side of curve. The prevalence of pre-operative coronal imbalance was calculated for stage I study. Post-operative CBD in patients who received surgery was measured to evaluate clinical outcomes for stage II study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative group | – | –Respectively recruited patients with DLS. Patients in this group were not surgically treatment. Only pre-operative radiographic parameters were measured. |
| Surgically treated group | – | Procedure: Posterior osteotomy correctionAll DLS patients received posterior osteotomy correction of spinal deformity. The immediate post-operative radiographic measurements were performed. |
Who may qualify
- Ages
- 50 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with degenerative scoliosis
Key inclusion criteria (1 listed)
- age > 50 years, diagnosis of DLS based on radiographies and previous medical history and Cobb angle >25°.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Posterior osteotomy correctionThe DLS patients underwent osteotomy including pedicle subtraction osteotomy (PSO) or Smith-Petersen osteotomy (SPO) | Procedure or surgery | Surgically treated group |
Primary outcome
The relationship between coronal balance classification and immediate post-operative imbalance using radiographic measurements
Time frame: Up to 3 months
This part of the study aims to analyze the immediate imbalance after surgery, most of the patients took post-operative films two weeks after surgery, but there were some patients who could not stand at that timepoint and the follow-up time was then at 3 months after surgery.
2 secondary outcomes
Relationship between post-operative imbalance and quality of life using quality of life questionnaires including SF-36, ODI and VAS
Time frame: Up to 1 year
Prevalence of coronal imbalance in degenerative scoliosis using radiographic measurements
Time frame: Up to 2 year pre-operative follow-up
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 8 Apr 2015.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by Nanjing University School of Medicine.
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 1 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 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The relationship between coronal balance classification and immediate post-operative imbalance using radiographic measurements (time frame: Up to 3 months). 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 8 Apr 2015.