Adult Spinal Deformity Surgery Real-World Functional Activity

Real-World Functional Activity in Adult Spinal Deformity Surgery

The purpose of this study is to measure functional activity and stability in spinal deformity patients utilizing motion analysis testing and accelerometers.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Thoracolumbar Deformity
• Intervention / Treatment: Device: Triaxial accelerometer

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Ranfranz; Phone Number: 507-293-7354; Email: Ranfranz.Rebecca@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Activity Monitor Assessment; Subjects will be assessed in the Motion Analysis Laboratory at Mayo Clinic Rochester and have activity monitored in the free-living environment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motion Analysis Lab - Change in function	Spatiotemporal measures including velocity, step/stride length, step width, single/double support times, and R/L temporal symmetriesm will be used to measure function.	Baseline, 6-12 weeks post-surgery, 1 year
Motion Analysis Lab - Change in gait	Gait will be measured by segmental and joint range of motion, peak kinetics during walking, and changes in deviation from normal bands using sensory processing measures.	Baseline, 6-12 weeks post-surgery, 1 year
Motion Analysis Lab - Change in trunk stability	Trunk stability will be measured by EMG frequency content and activation pattern during gait and postural sway.	Baseline, 6-12 weeks post-surgery, 1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Benjamin Elder, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 22-007211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No