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

2026. november 10. frissítette: 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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

35

Fázis

  • Nem alkalmazható

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: N/A
  • Beavatkozó modell: Egyetlen csoportos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Egyéb: Pedicle Subtraction Osteotomy

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

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in Bath Ankylosing Spondylitis Functional Index(BASFI) from baseline to 12 months after surgery (ΔBASFI)
Időkeret: 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)
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
the seventh cervical vertebra (C7)-sagittal vertical axis(SVA)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: at baseline, 6 months, and 12 months

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

at baseline, 6 months, and 12 months
global kyphosis(GK)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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.
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. október 30.

Elsődleges befejezés (Becsült)

2028. július 1.

A tanulmány befejezése (Becsült)

2029. július 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. október 29.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 10.

Első közzététel (Tényleges)

2026. november 12.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. november 12.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 10.

Utolsó ellenőrzés

2026. november 1.

Több információ

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