Older Patients Undergoing Lumbar Stenosis Surgery Using Fitbits for Capturing Outcomes
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-010363
About this study
The objectives of this study are to assess the feasibility of using Fitbits as a healthcare surveillance tool in the elderly population, to compare how Fitbit’s compare with PROMIS questionaries in terms of capturing postoperative outcomes, and to determine the benefits and limitations of Fitbits as a healthcare tool for spine surgeons.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patient must have a diagnosis of lumbar stenosis.
- Patients must be 60 years old or older.
- Patients must have no other significant musculoskeletal, cardiovascular, psychiatric, respiratory, neurological, urinary conditions or malignant comorbidities.
- Patients who can walk 100 feet independently.
- Patients must be willing to wear Fitbit throughout the requested duration of the study.
Exclusion Criteria:
- Patients outside the age bracket.
- Patients with debilitating pain that is not caused by lumbar stenosis.
- Patients on narcotic medication.
- Patients with an extensive social history of alcohol abuse.
- Patients with an extensive social history of tobacco abuse.
- Patients who are not indicated for lumbar decompressive laminectomy.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 9/13/2024. Questions regarding updates should be directed to the study team contact
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Mohamad Bydon, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available