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Clinical Trials in China / NCT06470152
Starting soon Not applicable

A Novel Classification of Sagittal Spinal Alignment to Aid Surgical Planning for Adult Spinal Deformity

NCT06470152 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Not applicable
Started
2024-12-01
Last updated
2024-06-24

Condition(s) studied

Adult Spinal DeformitySagittal DeformitySagittal AlignmentSagittal Imbalance

Investigational drug(s) / intervention(s)

Correction strategy in reference to our PI-dependent clustering of sagittal alignmentCorrection strategy in reference to the SAAS score

Correction strategy in reference to our PI-dependent clustering of sagittal alignment: For type I patients (PI \< 39.56°), the target LL = -0.13\*PI2+9.36\*PI-134.08; for type II patients (39.56° ≤ PI \< 49.16°), the target LL = 0.45\*PI+26.57; for type III patients (49.16° ≤ PI \< 58.31°), the target LL = -0.15\*PI2+17.09\*PI-420.57; for type IV patients (PI \> 58.31°), the target LL = 0.06\*PI2-7.55\*PI+289.77. Prediction intervals of 95% confidence is adopted as the target LL range.

Correction strategy in reference to the SAAS score: This new score is composed of three sagittal parameters (PI-LL, PT and TPA). For these three parameters, points were assigned based on offset with age-adjusted targets 0 points if the parameter was within 10 years of the patient's age (Match). For each 20 years above the age-adjusted target, 1 point was added (e.g., + 1 point between + 10 and + 30, + 2 points between +30 and +50). Conversely, 1 point was subtracted for each 20 years below the age-adjusted target (e.g., -1 point between -10 and -30, -2 points between -30 and -50). SAAS was calculated by adding all 3 components, creating a discreet score that could have a negative value (under corrected) or positive value (over corrected). SAAS was sub-categorized into "SAAS-Under" if it was less than -1, "SAAS-Match" if it was between -1 and + 1 or "SAAS-Over" if it was greater than + 1.

Study summary

Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with adult spinal deformity who underwent correction surgery with reference to our pelvic incidence-dependent (PI-dependent) clustering of sagittal spinal alignment and existing standards (sagittal age-adjusted score \[SAAS\], global alignment and proportion \[GAP\] score, and Roussouly classification). Our findings may provide tangible guidance for surgical decision-making in ASD.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. ≥ 18 years of age at the time of treatment; 2. Complete radiographic data, including standing posteroanterior and lateral whole-spine radiographs, lumbar computed tomography, and lumbar magnetic resonance imaging; 3. Radiographic evidence of ASD: sagittal vertical axis ≥ 50 mm, pelvic tilt ≥ 25°, pelvic incidence-lumbar lordosis mismatch ≥ 10°, and/or thoracic kyphosis ≥ 60°. Exclusion Criteria: 1. Any type of previous spinal surgery; 2. Other musculoskeletal problems impeding walking ability, syndromic or neuromuscular diseases such as Parkinson\&#39;s disease, inflammatory conditions such as ankylosing spondylitis, infectious conditions such as spinal tuberculosis, metabolic diseases such as severe osteoporosis, and/or serious general medical conditions such as sepsis or malignancy; 3. Pathology of deformity as follows: post-traumatic deformity, adult idiopathic scoliosis of the thoracic spine, or de-novo lumbar scoliosis; 4. Hip joint Kellgren-Lawrence grade ≥ II, history of hip joint and/or knee joint pain, and/or previous joint replacement.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital Capital Medical University Beijing Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06470152 on ClinicalTrials.gov ↗ ← All trials in China