Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05611775

Conditions

Degenerative Thoracolumbar Deformity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Triaxial accelerometer

Study Details

Brief summary:

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

Conditions

Degenerative Thoracolumbar Deformity

Study ID

NCT05611775

Start date

Jun 16, 2023

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Rebecca Ranfranz

507-293-7354Ranfranz.Rebecca@mayo.edu

Locations

Mayo Clinic Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-21.