Degenerative Thoracolumbar DeformityNCT05611775
Adult Spinal Deformity Surgery Real-World Functional Activity
A study testing Triaxial accelerometer in people with Degenerative Thoracolumbar Deformity, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to measure functional activity and stability in spinal deformity patients utilizing motion analysis testing and accelerometers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Thoracolumbar Deformity
- What is being tested?
- Triaxial accelerometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- ° Unable to return to Mayo Clinic for follow-up evaluation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Degenerative Thoracolumbar Deformity
- Being tested
- Triaxial accelerometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triaxial accelerometerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Activity Monitor Assessment | Other | Subjects will be assessed in the Motion Analysis Laboratory at Mayo Clinic Rochester and have activity monitored in the free-living environment. Receives: Device: Triaxial accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6-12 weeks post-surgery, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start16 Jun 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Thoracolumbar DeformityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin D. Elder, Mayo Clinic
- Investigators
- Benjamin Elder, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611775
- Sponsor's protocol ID
- 22-007211
- Status last verified
- Jan 2026
- First submitted
- 1 Nov 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Functional Activity in Adult Spinal Deformity Surgery
- ClinicalTrials.gov ID
- NCT05611775
- Acronym / sponsor ID
- 22-007211
- Conditions
- Degenerative Thoracolumbar Deformity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure functional activity and stability in spinal deformity patients utilizing motion analysis testing and accelerometers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activity Monitor Assessment | Other | Device: Triaxial accelerometerSubjects will be assessed in the Motion Analysis Laboratory at Mayo Clinic Rochester and have activity monitored in the free-living environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- ° Unable to return to Mayo Clinic for follow-up evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triaxial accelerometerMonitors 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. | Device | Activity Monitor Assessment |
Primary outcome
Motion Analysis Lab - Change in function
Time frame: Baseline, 6-12 weeks post-surgery, 1 year
Spatiotemporal measures including velocity, step/stride length, step width, single/double support times, and R/L temporal symmetriesm will be used to measure function.
Motion Analysis Lab - Change in gait
Time frame: Baseline, 6-12 weeks post-surgery, 1 year
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.
Motion Analysis Lab - Change in trunk stability
Time frame: Baseline, 6-12 weeks post-surgery, 1 year
Trunk stability will be measured by EMG frequency content and activation pattern during gait and postural sway.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Degenerative Thoracolumbar Deformity
RecruitingObservational study
Clinical Outcome Measure at Stryker Spine
Degenerative Disc Disease, Degenerative Scoliosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Elder, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triaxial accelerometer in people with Degenerative Thoracolumbar Deformity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Ranfranz (507-293-7354, Ranfranz.Rebecca@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motion Analysis Lab - Change in function (time frame: Baseline, 6-12 weeks post-surgery, 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.