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

NCT06470152 | Not Yet Recruiting

• 1 other identifier: xuanwu_ASD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adult Spinal Deformity; Sagittal Deformity; Sagittal Alignment; Sagittal Imbalance

Outcome Measures

Primary Outcomes (1)

• Proximal Junctional Kyphosis

  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.

  Two years after surgery

Secondary Outcomes (3)

• Scoliosis Research Society-22

  One month, 3 months, 6 months, 1 year, and 2 years after surgery

• Oswestry disability index

  One month, 3 months, 6 months, 1 year, and 2 years after surgery

• Achievement of minimal clinically important difference

  Two years after surgery

Study Arms (2)

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

EXPERIMENTAL

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

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

Correcting deformity according to the SAAS score.

Procedure: Correction strategy in reference to the SAAS score

Interventions

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

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.

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

Correction strategy in reference to the SAAS score PROCEDURE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age at the time of treatment;
• Complete radiographic data, including standing posteroanterior and lateral whole-spine radiographs, lumbar computed tomography, and lumbar magnetic resonance imaging;
• Radiographic evidence of ASD: sagittal vertical axis ≥ 50 mm, pelvic tilt ≥ 25°, pelvic incidence-lumbar lordosis mismatch ≥ 10°, and/or thoracic kyphosis ≥ 60°.

You may not qualify if:

• Any type of previous spinal surgery;
• 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;
• Pathology of deformity as follows: post-traumatic deformity, adult idiopathic scoliosis of the thoracic spine, or de-novo lumbar scoliosis;
• Hip joint Kellgren-Lawrence grade ≥ II, history of hip joint and/or knee joint pain, and/or previous joint replacement.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Central Study Contacts

Shibao Lu, M.D.

CONTACT

18810728213; wdfdoctor@126.com

Dongfan Wang, M.D.

CONTACT

13821337116; 1026607981@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)