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Not yet recruitingNCT07891676STEPSUpdated Oct 23, 2026

Scoliosis Treatment: Evaluating Patient Suitability

An observational study in Degenerative Scoliosis, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Xuanwu Hospital, Beijing · Observational

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
50 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Degenerative Scoliosis
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In context

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 357 studies on the registry; 226 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 24 months after surgery.

Secondary outcomes

  1. 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.

    Time frame: Baseline and 24 months after surgery.

  2. 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.

    Time frame: Baseline and 24 months after surgery.

  3. 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.

    Time frame: Baseline and 24 months after surgery.

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Study locations

No study locations are listed for this record.

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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2026
First posted
Oct 23, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Dec 31, 2028
CompletionEst.
Jan 31, 2029
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07891676
Responsible party
Sponsor
First posted
Oct 23, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Jan 31, 2029 (estimated)
Last update
Oct 23, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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