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Evaluating patients with spinal deformities

Longitudinal evaluation of gait, balance, spinal alignment andclinical outcomes in patients undergoing treatment for spinaldeformity. - Evaluating patients with spinal deformity

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58576
Enrollment
500
Registered
2026-04-30
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal deformity Spinal deformity

Interventions

Conventional treatment can be physiotherapy or bracing therapy.Surgical treatment is long fusion surgery, where at least 4 vertebrae are fixed.

Sponsors

Maastricht Universitair Medisch Centrum +
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with spinal deformity who are conservatively treated (e.g. physical therapy) or treated with long fusion surgery. Spinal deformity is defined as a deformity of the spine in either the coronal (> 10° lateral deviation of the vertical axis) or sagittal plane (Sagittal vertical axis > 5 cm or T1-spino pelvic inclination angle > 0°)); Long fusion surgery is defined as the fusion of least four vertebrae. Adolescents (12-17years, adolescent idiopathic scoliosis (AIS)) and adults (>18years, adult spinal deformity (ASD)) will be included. For the retrospective component: Patients diagnosed with spinal deformity who are conservatively treated (e.g. physical therapy) or treated with long fusion surgery, who completed 3D gait analysis, radiographs and clinical outcomes preoperatively and 6 and 12 months postoperatively  

Exclusion criteria

Exclusion criteria: Patients undergoing fusion surgery were less than four verbarae are fusedunable to walk independently for 15 minutes

Design outcomes

Primary

MeasureTime frame
Outcomes from 3D gait analysis:Spatiotemporal parameters, including variabilility (Coefficient of Variation)3D joint angles of trunk, pelvis, hip, knee, ankle3D joint momentsGround reaction forcesSpinal alignment parameters: e.g. sagittal vertical axis, S1-T12 angleX-ray outcome measures: major coronal Cobb angle (°), pelvic tilt (°), pelvic incidence (°), sacral slope (°), L1-S1 lumbar lordosis (°), L4-S1 lumbar lordosis (°), pelvic incidence – lumbar lordosis mismatch (°), thoracic kyphosis (°), T1 Pelvic Angle (°) and sagittal vertical axis (mm).PROMS:VAS scale assessing pain at the back and legs during last week (3 questions)RAND 36 assessing quality of Life (8 questions)HADS assessing feelings and symptoms (14 questions)PCS to measure the thoughts and feelings patients experience when having pain (13 question)EQ-5D to assess the healt status (5 questions)

Secondary

MeasureTime frame
Age, sex, body height, weight, BMI, leg length

Countries

Netherlands

Contacts

Public ContactRHJ Senden

Maastricht Universitair Medisch Centrum +

rachel.senden@mumc.nl0031-433874072

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026