Adult Spinal Deformity Surgery Real-World Functional Activity

NCT ID: NCT05611775

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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Conditions

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Degenerative Thoracolumbar Deformity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Triaxial accelerometer

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Benjamin D. Elder

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin Elder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rebecca Ranfranz

Role: CONTACT

507-293-7354

Other Identifiers

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22-007211

Identifier Type: -

Identifier Source: org_study_id

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