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Corrective Spinal Surgery for Severe Spinal Curvature in People With Ankylosing Spondylitis

2026年11月10日 更新者:Qingwen Tao、China-Japan Friendship Hospital

Study on the Efficacy Evaluation of AS Surgical Intervention and the Correlation Between Imaging Sagittal Plane Parameters and Disease Activity

This study is an exploratory self-controlled trial, aiming to preliminarily evaluate the effectiveness and safety of surgical treatment for ankylosing spondylitis.

研究概览

地位

尚未招聘

研究类型

介入性

注册 (估计的)

35

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age ≥18 years.
  • AS confirmed by a rheumatologist using the 1984 modified New York criteria: bilateral grade 2-4 or unilateral grade 3-4 radiographic sacroiliitis plus at least one clinical criterion (inflammatory low-back pain and stiffness for >3 months improving with exercise but not rest; restricted lumbar motion in sagittal and frontal planes; or age- and sex-adjusted restriction of chest expansion). A spine surgeon will confirm deformity and surgical eligibility; the diagnostic evidence and assessors will be recorded.
  • Severe structural spinal or spinopelvic deformity associated with AS.
  • Clinically significant impairment of posture, physical function, activities of daily living, or quality of life related to the deformity.
  • A clinical indication for spine-only single-level or two-level PSO with instrumented fusion, determined by the treating spinal surgical team.
  • Ability and willingness to complete the planned clinical, radiographic, and laboratory assessments.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Active infection, severe osteoporosis considered to preclude safe PSO by the treating team, or another systemic autoimmune disease likely to confound assessment. SpA-associated psoriasis, uveitis, and inflammatory bowel disease are permitted and will be documented, including activity and treatment.
  • Pregnant or lactating women.
  • With severe cardiovascular or cerebrovascular diseases, liver or kidney - Data collection may be affected by mental or language factors.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Pedicle Subtraction Osteotomy

To estimate changes in function and sagittal alignment at 12 months after pedicle subtraction osteotomy.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Bath Ankylosing Spondylitis Functional Index(BASFI) from baseline to 12 months after surgery (ΔBASFI)
大体时间:at baseline, 6 months, and 12 months

on the 0-10 scale. A negative change indicates improved function.

at baseline, 6 months, and 12 months
Change in T1 pelvic angle (TPA) from baseline to 12 months after surgery (ΔTPA)
大体时间:at baseline, 6 months, and 12 months

TPA will be measured on the standing lateral full-spine radiograph as the angle between the line connecting the center of the T1 vertebral body to the bicoxofemoral axis and the line connecting the bicoxofemoral axis to the midpoint of the superior endplate of S1. TPA incorporates both global spinal inclination and pelvic retroversion and provides a global measure of sagittal alignment. A negative change indicates improved function.

at baseline, 6 months, and 12 months

次要结果测量

结果测量
措施说明
大体时间
the seventh cervical vertebra (C7)-sagittal vertical axis(SVA)
大体时间:at baseline, 6 months, and 12 months

Measured on a full-length standing lateral radiograph as the horizontal distance from the C7 plumb line to the posterior-superior corner of the S1 endplate. Unit: millimeters (mm)

at baseline, 6 months, and 12 months
spinosacral angle(SSA)
大体时间:at baseline, 6 months, and 12 months

Measured as the angle between the C7 plumb line and the sacral endplate line. Unit: degrees (°)

at baseline, 6 months, and 12 months
Sagittal Pelvic Angle(SPA)
大体时间:at baseline, 6 months, and 12 months

Measured as the angle between the sacral endplate line and the line connecting the femoral head axis to the C7 plumb line. Unit: degrees (°)

at baseline, 6 months, and 12 months
pelvic incidence(PI)
大体时间:at baseline, 6 months, and 12 months

Measured as the angle between the line perpendicular to the sacral endplate at its midpoint and the line from that midpoint to the femoral head axis. Unit: degrees (°)

at baseline, 6 months, and 12 months
pelvic tilt(PT)
大体时间:at baseline, 6 months, and 12 months

Measured as the angle between the vertical line and the line from the femoral head axis to the sacral endplate midpoint. Unit: degrees (°)

at baseline, 6 months, and 12 months
sacral slope(SS)
大体时间:at baseline, 6 months, and 12 months

Measured as the angle between the sacral endplate line and the horizontal line. Unit: degrees (°)

at baseline, 6 months, and 12 months
Pelvic Incidence(PI)-lumbar lordosis(LL) mismatch
大体时间:at baseline, 6 months, and 12 months

Calculated as PI minus LL. Unit: degrees (°)

at baseline, 6 months, and 12 months
global kyphosis(GK)
大体时间:at baseline, 6 months, and 12 months

Measured as the angle between the superior endplate of the upper-most tilted vertebra and the inferior endplate of the lower-most tilted vertebra in the kyphotic segment. Unit: degrees (°)

at baseline, 6 months, and 12 months
thoracic kyphosis(TK)
大体时间:at baseline, 6 months, and 12 months

Measured as the Cobb angle between the superior endplate of T4 and the inferior endplate of T12. Unit: degrees (°)

at baseline, 6 months, and 12 months
oracolumbar kyphosis(TLK)
大体时间:at baseline, 6 months, and 12 months

Measured as the Cobb angle between the superior endplate of T10 and the inferior endplate of L2. Unit: degrees (°)

at baseline, 6 months, and 12 months
lumbar lordosis(LL)
大体时间:at baseline, 6 months, and 12 months

Measured as the Cobb angle between the superior endplate of L1 and the superior endplate of S1. Unit: degrees (°)

at baseline, 6 months, and 12 months
Kyphosis apex vertebra
大体时间:at baseline, 6 months, and 12 months

Identified as the vertebra at the apex of the maximal kyphotic curve on the lateral radiograph. Unit: vertebral level (e.g.T8, T9)

at baseline, 6 months, and 12 months
Local osteotomy angle
大体时间:at baseline, 6 months, and 12 months

Measured as the angle created at the osteotomy site between the superior and inferior endplates of the resected/adjacent vertebrae on intraoperative or postoperative imaging. Unit: degrees (°)

at baseline, 6 months, and 12 months
the second cervical vertebra(C2)-the seventh cervical vertebra(C7) lordosis.
大体时间:at baseline, 6 months, and 12 months

Measured as the Cobb angle between the inferior endplate of C2 and the inferior endplate of C7. Unit: degrees (°)

at baseline, 6 months, and 12 months
the second cervical vertebra(C2)-the seventh cervical vertebra(C7) sagittal vertical axis(SVA)
大体时间:at baseline, 6 months, and 12 months

Measured as the horizontal distance from the C2 plumb line (vertical line from the C2 centroid) to the posterior-superior corner of C7. Unit: millimeters (mm)

at baseline, 6 months, and 12 months
the first thoracic vertebra(T1) slope
大体时间:at baseline, 6 months, and 12 months

Measured as the angle between the superior endplate of T1 and the horizontal line. Unit: degrees (°)

at baseline, 6 months, and 12 months
the first thoracic vertebra(T1) angle
大体时间:at baseline, 6 months, and 12 months

T1 angle measured between the T1 endplate line and the line from the T1 centroid to the C7 centroid. Unit: degrees (°)

at baseline, 6 months, and 12 months
Neck tilt
大体时间:at baseline, 6 months, and 12 months

Neck tilt measured as the angle between the vertical line and the line from the sternal notch to the T1 centroid

at baseline, 6 months, and 12 months
Coronal Cobb angle
大体时间:at baseline, 6 months, and 12 months

Measured as the Cobb angle between the superior endplate of the upper-end vertebra and the inferior endplate of the lower-end vertebra of the coronal curve. Unit: degrees (°)

at baseline, 6 months, and 12 months
Coronal vertical axis
大体时间:at baseline, 6 months, and 12 months

Measured as the horizontal distance from the C7 plumb line to the sacral midline (center of S1). Unit: millimeters (mm)

at baseline, 6 months, and 12 months
Pelvic tilt in the coronal plane
大体时间:at baseline, 6 months, and 12 months

Measured as the angle between the horizontal line and the line connecting the bilateral femoral head centers (or the sacral endplate line) on the AP radiograph. Unit: degrees (°)

at baseline, 6 months, and 12 months
proximal junctional kyphosis(PJK)
大体时间:at baseline, 6 months, and 12 months

Measured as the angle between the inferior endplate of the upper instrumented vertebra (UIV) and the superior endplate of the vertebra two levels above the UIV (UIV+2). Unit: degrees (°)

at baseline, 6 months, and 12 months
proximal junctional failure(PJF)
大体时间:at baseline, 6 months, and 12 months

Defined by the presence of proximal junctional fracture, implant failure, or revision surgery at the proximal junction. Unit: event (yes/no)

at baseline, 6 months, and 12 months
Implant failure
大体时间:at baseline, 6 months, and 12 months

Defined as radiographic evidence of screw/rod breakage, loosening, or pullout. Unit: event (yes/no)

at baseline, 6 months, and 12 months
surgical safety outcomes
大体时间:at baseline, 6 months, and 12 months

Recorded as events (yes/no) or continuous measures during the perioperative and follow-up periods, including but not limited to: intraoperative blood loss (mL), operative time (min), length of hospital stay (d), transfusion rate, surgical site/deep infection rate, neurologic deficit, dural tear, deep vein thrombosis/pulmonary embolism, implant failure, revision surgery rate, readmission rate, and mortality. Units: mL / min / d / event (yes/no) / proportion (%). Lower event incidence, less blood loss, and shorter operative time and hospital stay indicate better safety; the converse indicates worse safety. Serious complications (infection, neurologic deficit, implant failure, revision, death) indicate worse safety.

at baseline, 6 months, and 12 months
Ankylosing Spondylitis Disease Activity Score based on C-reactive protein(ASDAS-CRP)
大体时间:at baseline, 6 months, and 12 months

Composite score calculated from four patient-reported items (back pain, duration of morning stiffness, patient global assessment, peripheral joint pain/swelling) and serum CRP using a weighted formula. Minimum = 0; maximum = no fixed upper limit (typically ~0-6; theoretical minimum 0). Higher scores indicate worse disease activity; lower scores indicate better disease activity. Cut-offs: < 1.3 = inactive disease, < 2.1 = low disease activity, > 2.1 = high disease activity.

at baseline, 6 months, and 12 months
C-reactive protein(CRP)
大体时间:at baseline, 6 months, and 12 months

Measured in peripheral venous blood as serum CRP concentration. Minimum = 0 (cannot be negative); maximum = no fixed upper limit (assay-dependent). Unit: mg/L (or mg/dL). Higher concentrations indicate greater systemic inflammatory burden (worse); lower concentrations indicate less inflammation (better). Normal reference is typically < 5 mg/L (some laboratories < 3 mg/L).

at baseline, 6 months, and 12 months
Erythrocyte Sedimentation Rate(ESR)
大体时间:at baseline, 6 months, and 12 months

Measured in peripheral venous blood by the Westergren method as the distance erythrocytes fall at the end of 1 hour. Minimum = 0; maximum = no fixed upper limit (assay-dependent). Unit: mm/h (millimeters per hour). Higher values indicate greater inflammatory activity (worse); lower values indicate better status. Reference ranges are age/sex-specific (e.g., < 15 mm/h in men, < 20 mm/h in women).

at baseline, 6 months, and 12 months
Bath Ankylosing Spondylitis Disease Activity Index(BASDAI)
大体时间:at baseline, 6 months, and 12 months

Derived from six patient-reported items (fatigue, neck/back/hip pain, peripheral joint pain/swelling, enthesitis, severity of morning stiffness, duration of morning stiffness), each scored on a 0-10 numeric rating/visual analogue scale; total = mean of the six items. Minimum = 0; maximum = 10. Unit: 0-10 score (unitless). Higher scores indicate worse disease activity; lower scores indicate better disease activity. Cut-off: < 4 = low disease activity/well controlled; ≥ 4 = active disease.

at baseline, 6 months, and 12 months
36-Item Short Form Health Survey(SF-36)
大体时间:at baseline, 6 months, and 12 months

Thirty-six patient-reported items yield eight domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health) and two summary scores (Physical Component Summary [PCS] and Mental Component Summary [MCS]). All domains and summary scores are linearly transformed to a 0-100 scale; minimum = 0, maximum = 100. Unit: 0-100 score (unitless). Higher scores indicate better health-related quality of life; lower scores indicate worse.

at baseline, 6 months, and 12 months
Visual Analogue Scale for Pain(VAS)
大体时间:at baseline, 6 months, and 12 months

The patient marks current status on a 100-mm (or 0-10) horizontal/vertical line; the distance from the "none" anchor to the mark is measured. Minimum = 0; maximum = 100 mm (or 0-10). Unit: mm (or 0-10 score, unitless). In ankylosing spondylitis studies, pain VAS (e.g., back pain over the past week) and patient global assessment VAS (e.g., overall disease status over the past week) are typically measured separately and should be reported as distinct constructs. Higher scores indicate worse pain/overall status; lower scores indicate better status.

at baseline, 6 months, and 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月30日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2029年7月1日

研究注册日期

首次提交

2026年10月29日

首先提交符合 QC 标准的

2026年11月10日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年11月1日

更多信息

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研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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