Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
NCT Number: NCT06470152
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100053, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Two years after surgery
Proximal junctional kyphosis (PJK) was defined by a proximal junctional angle (PJA) (Cobb angle between the superior endplate of UIV+2 and inferior endplate of UIV) of > 10° and a PJA angle difference of > 10° from baseline at any time point up to latest follow-up.
Time frame: One month, 3 months, 6 months, 1 year, and 2 years after surgery
The 22-item SRS-22r questionnaire is specific to scoliosis-related patient-reported outcomes, and consists of 6 domains: function, pain, self-image, mental health, satisfaction, and subtotal, with each domain being scored from 1 to 5 where higher scores correspond to better patient outcomes.
Time frame: One month, 3 months, 6 months, 1 year, and 2 years after surgery
The validated ODI is a self-administered questionnaire for evaluating back-specific functional disability, consisting of 10 items with scores from 0 to 5, and higher ODI indicates more severe disability.
Time frame: Two years after surgery
A prespecified MCID of 10 points was used for the ODI. The minimum clinically important difference (MCID) values for the SRS-22r based on data from a Japanese cohort have previously been reported as follows: function = 0.90, pain = 0.85, self-image = 1.05, mental health = 0.70, and subtotal = 1.05.
Contact information is provided by the study sponsor or research team.
Dongfan Wang, M.D.
CONTACT
Shibao Lu, M.D.
CONTACT
Xuanwu Hospital, Beijing
Other
Pelvic Incidence-Dependent Clustering of Sagittal Spinal Alignment: A Novel Classification to Aid Surgical Planning for Adult Spinal Deformity
Acronym: CSSAASD
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