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NCT Number: NCT06470152

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location contact

Dongfan Wang

CONTACT

[email protected]

13821337116

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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°.

Exclusion criteria

  • Any type of previous spinal surgery;
  • 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;
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Proximal Junctional Kyphosis

    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.

Secondary outcomes

  1. Scoliosis Research Society-22

    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.

  2. Oswestry disability index

    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.

  3. Achievement of minimal clinically important difference

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dongfan Wang, M.D.

CONTACT

[email protected]

13821337116

Shibao Lu, M.D.

CONTACT

[email protected]

18810728213

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Pelvic Incidence-Dependent Clustering of Sagittal Spinal Alignment: A Novel Classification to Aid Surgical Planning for Adult Spinal Deformity

Acronym: CSSAASD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2024
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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