Status:
COMPLETED
Twenty-Four Seven Functional Status in Total Hip Replacement
Lead Sponsor:
Koneksa Health
Conditions:
Total Hip Replacement
Eligibility:
All Genders
30+ years
Brief Summary
The goal of this observational study is to define digital remote monitoring measures for functional status (activities of daily living) in patients receiving total hip replacement. Functional status w...
Detailed Description
Approximately 25 participants will be enrolled in this study. The study consists of a 1-week Screening period, a 1-week Baseline period, up to 6-week assessment period (post-surgery), and an end of pa...
Eligibility Criteria
Inclusion
- Participants diagnosed with osteoarthritis of the hip or degenerative joint disease and have decided to undergo total hip arthroplasty
- Patients willing to sign the informed consent form
- Age 30 and older
- Demonstrated ability to perform satisfactory at-home assessments as well as the mobile application to synchronize data collection and respond to questionnaires during the screening period
Exclusion
- Participants with clinically unstable serious diseases (e.g., heart or lung disease) that would deem them unfit for the study in the Investigator's opinion
- Secondary total hip replacement on the same side
- Hip replacement for neoplasm, proximal femoral fracture, or other causes than osteoarthritis
- Contemporary bilateral replacement
- History of substance abuse in the last 6 months, excluding medical or recreational non-inhaled marijuana
- Current cancer
- Presence of neurological diseases previous to and/or following surgery (peripheral neuropathy is generally acceptable)
- Congenital abnormalities
- Patients with active infection within last 30 days
- Psychotropic drugs except for pain management and antidepressants
Key Trial Info
Start Date :
December 13 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 7 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06209216
Start Date
December 13 2023
End Date
October 7 2024
Last Update
November 12 2024
Active Locations (1)
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1
Premier Medical Associates
The Villages, Florida, United States, 32159