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

NANot yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

December 1, 2027

Study Completion Date

December 1, 2027

Conditions
Adult Spinal DeformitySagittal DeformitySagittal AlignmentSagittal Imbalance
Interventions
PROCEDURE

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.

PROCEDURE

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."

Trial Locations (1)

100053

Xuanwu Hospital Capital Medical University, Beijing

All Listed Sponsors
lead

Xuanwu Hospital, Beijing

OTHER

NCT06470152 - A Novel Classification of Sagittal Spinal Alignment to Aid Surgical Planning for Adult Spinal Deformity | Biotech Hunter | Biotech Hunter