Twenty-Four Seven Functional Status in Total Hip Replacement (LEARNT)

Koneksa Health

Status: Enrolling

Conditions: Total Hip Replacement

Study type: Observational

Funder types: Industry

Identifiers

NCT06209216

KH009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

Total Hip Replacement

Description:

No intervention