Investigating Patient Satisfaction With Smart Knee Implants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
The main goal of this study is to see if there is a connection between the social and economic resources available in a patient's neighborhood (measured by the Area Deprivation Index, ADI) and their recovery after knee replacement surgery, as tracked through remote monitoring. A secondary goal is to find out if patients' self-reported pain and function score are linked to their actual physical improvement after surgery as measured by a remote therapeutic monitoring (RTM) device. Additionally, this study examines whether RTM can reduce the number of postoperative clinic visits within the first 90 days after surgery while maintaining patient satisfaction and patient-reported outcome measures (PROMs).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients over 18 years of age
Patients undergoing unilateral primary or revision total knee arthroplasty with the smart knee implant or standard-of-care
Disqualifiers
Patients who receive contralateral knee replacement or contralateral or unilateral hip replacement within 90 days before or after their knee replacement in this study
Patients with post-operative weight-bearing restrictions or physical deconditioning prohibiting routine physical therapy participation
Trial design
Design model
Parallel
Treatments tested in this trial
Smart Knee Implant
DeviceAn important advancement in objective recovery data occurred when the first ever 'smart' knee implant for remote therapeutic monitoring (RTM) after total knee arthroplasty (TKA) was released in 2021. The implant includes both a prosthesis for TKA and a stem, the latter of which records the following metrics: step count, distance traveled, tibial range-of-motion (ROM), functional ROM, average walking speed, stride length, and cadence. The implant sends the recordings to a mobile platform. Additionally, it collects and analyzes patient across the entire population of users and creates percentiles for each metric based on patient age, gender and time since surgery. These "recovery curves" provide more objective data for practitioners and patients to evaluate recovery progress and make adjustments to their care plans accordingly.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Smart Knee ImplantExperimental treatment 1 intervention
Group B: Standard-of-Care Knee ArthroplastyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Patient-Reported Outcomes and Satisfaction
The patients in both arms will complete surveys on their subjective pain and function as well as their subjective satisfaction with the knee arthroplasty preparation, surgery, and recovery. The investigators will compare these surveys between the experimental group and the standard-of-care group at select time points.
Time frame
From enrollment to 1 year after arthroplastySecondary outcomes
1
Area Deprivation Index Correlation with Recovery
The investigators will be retrospectively collecting patient records that will include patient neighborhood locations to calculate an Area Deprivation Index (ADI) score. These patients will be those who have received the smart knee implant before this study was approved, and the investigators will evaluate the correlation between smart knee implant recovery curve percentiles and the Area Deprivation Index in patients receiving the smart knee implant. A high Area Deprivation Index means being more socioeconomically deprived, and the scale is scored from 0 to 100.
Time frame
up to 1 year2
Correlation between Knee Injury and Osteoarthritis Outcome score for Joint Replacement (KOOS, JR.) and smart knee implant recovery curve percentiles
The investigators will collect the Knee Injury and Osteoarthritis Outcome score for Joint Replacement (KOOS, JR.) and smart knee implant recovery curve percentiles for the patients that receive smart knee implants and will calculate correlation scores between them. The KOOS, JR. is scored from 0 to 100 and a higher score means better knee function.
Time frame
From enrollment to 1 year after arthroplasty3
Complications after Knee Arthroplasty
The investigators will record the rate of patients requiring assistive walking devices, revision arthroplasty, manipulation under anesthesia, and the rates of periprosthetic joint infection between patients who receive smart knee implants and the standard-of-care joint arthroplasty.
Time frame
From enrollment to 1 year after arthroplastySponsors and contacts
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Source ClinicalTrials.gov