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

Capital Medical University

Status: Not yet enrolling

Conditions: Sagittal Imbalance; Sagittal Deformity; Sagittal Alignment; Adult Spinal Deformity

Treatments: Procedure: Correction strategy in reference to the SAAS score; Procedure: Correction strategy in reference to our PI-dependent clustering of sagittal alignment

Study type: Interventional

Funder types: Other

Identifiers

NCT06470152

xuanwu_ASD

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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'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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Patients with ASD undergoing correction surgery in reference to our novel criteria

Experimental group

Description:

Correcting deformity according to the PI-dependent clustering of sagittal spinal alignment.

Treatment:

Procedure: Correction strategy in reference to our PI-dependent clustering of sagittal alignment

Patients with ASD undergoing correction surgery in reference to SAAS score.

Other group

Description:

Correcting deformity according to the SAAS score.

Treatment:

Procedure: Correction strategy in reference to the SAAS score