Recruiting NCT05611775
Adult Spinal Deformity Surgery Real-World Functional Activity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Triaxial accelerometer.
- Who it may be relevant to
- Registry conditions: Degenerative Thoracolumbar Deformity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real-World Functional Activity in Adult Spinal Deformity Surgery
Overview
The purpose of this study is to measure functional activity and stability in spinal deformity patients utilizing motion analysis testing and accelerometers.
Interventions
- Device Triaxial accelerometer
Monitors placed on the waist, thigh, and bilateral ankles. Accelerometry will measure patients' physical activities in the free-living environment for 4 consecutive days. The patients will wear the monitor during waking hours and remove it during sleeping, showering, and swimming time.
Primary outcome measures
- Motion Analysis Lab - Change in function [Time frame: Baseline, 6-12 weeks post-surgery, 1 year]
- Motion Analysis Lab - Change in gait [Time frame: Baseline, 6-12 weeks post-surgery, 1 year]
- Motion Analysis Lab - Change in trunk stability [Time frame: Baseline, 6-12 weeks post-surgery, 1 year]
Eligibility criteria
Inclusion criteria
- Diagnosis of degenerative thoracolumbar deformity
- Deformity correction surgery scheduled with either Dr. Elder or Dr. Fogelson, minimum 4-level fusion with fixation to the pelvis.
Exclusion criteria
° Unable to return to Mayo Clinic for follow-up evaluation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic Minnesota — Rochester
Identifiers
NCT: NCT05611775 · 22-007211