A Novel Classification of Sagittal Spinal Alignment to Aid Surgical Planning for Adult Spinal Deformity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
Qualifiers
≥ 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°.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Correction strategy in reference to our PI-dependent clustering of sagittal alignment
- Correction strategy in reference to the SAAS score
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov