Clinical trial NCT06209216: Twenty-Four Seven Functional Status in Total Hip Replacement
Official title: An Observational Study to Explore Twenty-Four Seven Functional Status Measures in Total Hip Replacement (LEARNT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Hip Replacement
Keywords: Functional Status
Lead sponsor: Koneksa Health
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants requiring total hip replacement surgery will participate in this study for \~6 weeks.

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 will be collected using a study iPhone and two wearable wrist monitors.

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 participation (EOP) visit. With the exception of in clinic visits at the beginning and end of study, this observational study will leverage fully remote data capture.

The categories of functional status and corresponding measures captured in this study include:

1. Physical activity and mobility, with outcome measures including hourly and daily step count, gait speed, and metabolic equivalent of task.
2. Vital signs, with outcome measures including heart rate, heart rate variability and blood pressure.
3. Sleep concept, with outcome measures including sleep duration, sleep quality, sleepiness and sleep timing.
4. HRQoL captured using validated instruments and diaries via electronic patient reported outcomes (ePRO) platforms, assessing aspects of health that are meaningful to individual's hip replacement such as disease- and treatment-related symptoms and the impact their physical health may have on activities of daily living, their work life, and socializing.

Eligibility criteria: Inclusion Criteria:

1. Participants diagnosed with osteoarthritis of the hip or degenerative joint disease and have decided to undergo total hip arthroplasty
2. Patients willing to sign the informed consent form
3. Age 30 and older
4. 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 Criteria:

1. 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
2. Secondary total hip replacement on the same side
3. Hip replacement for neoplasm, proximal femoral fracture, or other causes than osteoarthritis
4. Contemporary bilateral replacement
5. History of substance abuse in the last 6 months, excluding medical or recreational non-inhaled marijuana
6. Current cancer
7. Presence of neurological diseases previous to and/or following surgery (peripheral neuropathy is generally acceptable)
8. Congenital abnormalities
9. Patients with active infection within last 30 days
10. Psychotropic drugs except for pain management and antidepressants

Primary outcomes:
measure: Overall Hip Assessment - In Clinic
timeFrame: Baseline Day 1 through Day 42 End of Participation
measure: Mobile Vital Signs via Mobile Blood Pressure Cuff
timeFrame: Baseline Day 1 through Day 42 End of Participation
measure: Daily Measurements via Wrist-worn Device
timeFrame: Baseline Day 1 through Day 42 End of Participation
measure: Objective Measures of Sleep via Wrist-worn Device
timeFrame: Baseline Day 1 through Day 42 End of Participation
measure: Motor Function Assessments via Koneksa Application
timeFrame: Baseline Day 1 through Day 42 End of Participation
measure: Participant Diary via Koneksa Application
timeFrame: Baseline Day 1 through Day 42 End of Participation
measure: Sleep Electronic Patient Reported Outcomes
timeFrame: Baseline Day 1 through Day 42 End of Participation
measure: Quality of Life Patient Reported Questionnaire Scores
timeFrame: Baseline Day 1 through Day 42 End of Participation
measure: Additional Questionnaire via Koneksa Platform
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Clinician Reported Adverse Events
timeFrame: Baseline Day 1 through Day 365 End of Participation
Secondary outcomes:
Other outcomes:
Locations:
city: The Villages
country: United States
facility: Premier Medical Associates
state: Florida
Study officials:
References: