Degenerative ScoliosisSTEPSNCT07891676
Scoliosis Treatment: Evaluating Patient Suitability
An observational study of Degenerative Scoliosis, run by Xuanwu Hospital, Beijing.
Trial summary
Degenerative scoliosis can cause back pain, leg pain, difficulty walking, and impaired daily functioning. When spinal fusion is required, choosing the appropriate fusion extent remains challenging. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Degenerative Scoliosis
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Consecutive eligible adults older than 50 years with symptomatic de novo degenerative scoliosis who are scheduled to undergo instrumented spinal fusion at participating tertiary spine centers.
Who may be able to join
- Age older than 50 years.
- De novo degenerative scoliosis with a coronal Cobb angle greater than 10 degrees on standing preoperative radiographs.
- Scheduled to undergo instrumented spinal fusion for degenerative scoliosis.
- Ability to complete the required patient-reported outcome assessments.
- Willingness to participate in postoperative follow-up through 24 months.
- Provision of written informed consent.
Who cannot join
- Previous spinal surgery.
- Scoliosis attributable primarily to congenital, neuromuscular, or adolescent-onset idiopathic conditions.
- Active spinal infection, spinal malignancy, or acute spinal fracture substantially affecting the planned treatment or alignment assessment.
- Other conditions that preclude valid assessment of spinal alignment or functional outcomes.
- Inability to provide informed consent or complete the required study assessments.
About this study
Official title: Scoliosis Treatment: Evaluating Patient Suitability (STEPS)-A Multicenter Prospective Observational Cohort Study Comparing Short-Segment and Long-Segment Fusion in Degenerative Scoliosis
Degenerative scoliosis can cause back pain, leg pain, difficulty walking, and impaired daily functioning. When spinal fusion is required, choosing the appropriate fusion extent remains challenging. Short-segment fusion involves fewer spinal levels, whereas long-segment fusion offers greater potential for deformity correction but requires more extensive surgery. It remains uncertain which patients are more likely to benefit from each strategy.
This multicenter prospective observational cohort study will investigate whether preoperative spinal alignment modifies the comparative clinical benefit of short-segment and long-segment fusion. Patients will receive surgery selected through routine clinical decision-making, without treatment assignment by the study. Clinical information, standing spinal radiographs, and patient-reported outcomes will be collected before surgery and during postoperative follow-up.
The primary outcome will be clinically meaningful improvement in the Scoliosis Research Society-22r subtotal score at 24 months after surgery. The study aims to identify patient subgroups with greater benefit from either fusion strategy and to develop clinically interpretable criteria that may support individualized selection of fusion extent.
- Conditions
- Degenerative Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Short-Segment Fusion | Participants undergoing instrumented spinal fusion involving fewer than four fused motion segments, selected through routine clinical decision-making. | |
| Long-Segment Fusion | Participants undergoing instrumented spinal fusion involving four or more fused motion segments, selected through routine clinical decision-making. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of the Minimum Clinically Important Difference in the Scoliosis Research Society-22r Subtotal Score
Proportion of participants achieving an increase of more than 0.98 points from baseline in the Scoliosis Research Society-22r (SRS-22r) subtotal score. The subtotal score includes the function/activity, pain, self-image, and mental health domains and excludes the satisfaction domain. Scores range from 1 to 5, with higher scores indicating better health-related quality of life.
Measured: Baseline and 24 months after surgery.
Secondary outcomes (3)
Achievement of the Minimum Clinically Important Difference in the Oswestry Disability Index
Proportion of participants achieving a decrease of more than 18.9 points from baseline in the Oswestry Disability Index (ODI). Scores range from 0 to 100, with higher scores indicating greater disability.
Measured: Baseline and 24 months after surgery.
Achievement of the Minimum Clinically Important Difference in Back Pain
Proportion of participants achieving a decrease of more than 1.9 points from baseline in the visual analog scale score for back pain. Scores range from 0 to 10, with higher scores indicating more severe pain.
Measured: Baseline and 24 months after surgery.
Achievement of the Minimum Clinically Important Difference in Leg Pain
Proportion of participants achieving a decrease of more than 1.5 points from baseline in the visual analog scale score for leg pain. Scores range from 0 to 10, with higher scores indicating more severe pain.
Measured: Baseline and 24 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891676
- Sponsor's protocol ID
- Xuanwu-Scoliosis-2601
- Other IDs
- ZLRK202517
- Acronym
- STEPS
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scoliosis Treatment: Evaluating Patient Suitability (STEPS)-A Multicenter Prospective Observational Cohort Study Comparing Short-Segment and Long-Segment Fusion in Degenerative Scoliosis
- ClinicalTrials.gov ID
- NCT07891676
- Acronym / sponsor ID
- STEPS / Xuanwu-Scoliosis-2601
- Conditions
- Degenerative Scoliosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 23 Oct 2026 (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.
Degenerative scoliosis can cause back pain, leg pain, difficulty walking, and impaired daily functioning. When spinal fusion is required, choosing the appropriate fusion extent remains challenging. Short-segment fusion involves fewer spinal levels, whereas long-segment fusion offers greater potential for deformity correction but requires more extensive surgery. It remains uncertain which patients are more likely to benefit from each strategy.
This multicenter prospective observational cohort study will investigate whether preoperative spinal alignment modifies the comparative clinical benefit of short-segment and long-segment fusion. Patients will receive surgery selected through routine clinical decision-making, without treatment assignment by the study. Clinical information, standing spinal radiographs, and patient-reported outcomes will be collected before surgery and during postoperative follow-up.
The primary outcome will be clinically meaningful improvement in the Scoliosis Research Society-22r subtotal score at 24 months after surgery. The study aims to identify patient subgroups with greater benefit from either fusion strategy and to develop clinically interpretable criteria that may support individualized selection of fusion extent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-Segment Fusion | – | –Participants undergoing instrumented spinal fusion involving fewer than four fused motion segments, selected through routine clinical decision-making. |
| Long-Segment Fusion | – | –Participants undergoing instrumented spinal fusion involving four or more fused motion segments, selected through routine clinical decision-making. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive eligible adults older than 50 years with symptomatic de novo degenerative scoliosis who are scheduled to undergo instrumented spinal fusion at participating tertiary spine centers.
Key inclusion criteria (6 listed)
- Age older than 50 years.
- De novo degenerative scoliosis with a coronal Cobb angle greater than 10 degrees on standing preoperative radiographs.
- Scheduled to undergo instrumented spinal fusion for degenerative scoliosis.
- Ability to complete the required patient-reported outcome assessments.
- Willingness to participate in postoperative follow-up through 24 months.
Key exclusion criteria (5 listed)
- Previous spinal surgery.
- Scoliosis attributable primarily to congenital, neuromuscular, or adolescent-onset idiopathic conditions.
- Active spinal infection, spinal malignancy, or acute spinal fracture substantially affecting the planned treatment or alignment assessment.
- Other conditions that preclude valid assessment of spinal alignment or functional outcomes.
- Inability to provide informed consent or complete the required study assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Achievement of the Minimum Clinically Important Difference in the Scoliosis Research Society-22r Subtotal Score
Time frame: Baseline and 24 months after surgery.
Proportion of participants achieving an increase of more than 0.98 points from baseline in the Scoliosis Research Society-22r (SRS-22r) subtotal score. The subtotal score includes the function/activity, pain, self-image, and mental health domains and excludes the satisfaction domain. Scores range from 1 to 5, with higher scores indicating better health-related quality of life.
3 secondary outcomes
Achievement of the Minimum Clinically Important Difference in the Oswestry Disability Index
Time frame: Baseline and 24 months after surgery.
Achievement of the Minimum Clinically Important Difference in Back Pain
Time frame: Baseline and 24 months after surgery.
Achievement of the Minimum Clinically Important Difference in Leg Pain
Time frame: Baseline and 24 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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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.
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 Degenerative Scoliosis, run by Xuanwu Hospital, Beijing.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Achievement of the Minimum Clinically Important Difference in the Scoliosis Research Society-22r Subtotal Score (time frame: Baseline and 24 months after surgery.). 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 23 Oct 2026.