Scoliosis Treatment: Evaluating Patient Suitability

NCT07891676 | Not Yet Recruiting

• 2 other identifiers: Xuanwu-Scoliosis-2601ZLRK202517
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Degenerative Scoliosis

Outcome Measures

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.

  Baseline and 24 months after surgery.

Secondary Outcomes (3)

• Achievement of the Minimum Clinically Important Difference in the Oswestry Disability Index

  Baseline and 24 months after surgery.

• Achievement of the Minimum Clinically Important Difference in Back Pain

  Baseline and 24 months after surgery.

• Achievement of the Minimum Clinically Important Difference in Leg Pain

  Baseline and 24 months after surgery.

Study Arms (2)

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: October 23, 2026

Record last verified: 2026-10