Corrective Spinal Surgery for Severe Spinal Curvature in People With Ankylosing Spondylitis
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の:Pedicle Subtraction Osteotomy
|
To estimate changes in function and sagittal alignment at 12 months after pedicle subtraction osteotomy. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Bath Ankylosing Spondylitis Functional Index(BASFI) from baseline to 12 months after surgery (ΔBASFI)
時間枠: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
|
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Change in T1 pelvic angle (TPA) from baseline to 12 months after surgery (ΔTPA)
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
the seventh cervical vertebra (C7)-sagittal vertical axis(SVA)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠:at baseline, 6 months, and 12 months
|
Calculated as PI minus LL. Unit: degrees (°) |
at baseline, 6 months, and 12 months
|
|
global kyphosis(GK)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
|
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Local osteotomy angle
時間枠: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
|
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the second cervical vertebra(C2)-the seventh cervical vertebra(C7) lordosis.
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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