Study of the KinexConnect Telerehabilitation System (KCTRS)

Study Purpose

A randomized, single-blind study comparing telerehabilitation at home with continuous passive motion (CPM) and a tablet-based patient engagement application (KinexConnect) versus traditional outpatient physical therapy (PT) following total knee arthroplasty (TKA).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Planned for a primary unilateral TKA. 2. At least 21 years of age. 3. Capable of understanding the study requirements and giving written informed consent. 4. Willing and able to comply with either therapy program. 5. Has easy access to caregiver support.

Exclusion Criteria:

1. Active range-of-motion (ARoM) < 80 degrees in target knee. 2. Unable to read and write in English. 3. Lack of email capability to receive recovery trend information. 4. Previous knee intervention in target knee. 5. Previous knee joint infection in either knee. 6. Received a revision TKA (opposite knee). 7. Planned for bilateral TKA. 8. Self-reported pregnancy. 9. Reason for arthroplasty being for the treatment of fracture, infection or malignancy. 10. Other physical or mental impairments or medical conditions that may affect ability to complete therapy as prescribed. 11. Unwilling to participate.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04191798
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kinex Medical Company, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Barron Bremner, DO
Principal Investigator Affiliation Des Moines Orthopedic Suregons
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Study Website: View Trial Website
Additional Details

The Randomized Study of the KinexConnect Telerehabilitation System is a 1:1 randomized, single-blind, prospective cohort study to be conducted at one investigational site in the United States. The study compares at-home telerehabilitation system versus traditional outpatient PT following total knee arthroplasty (TKA). The telerehabilitation system involves a tablet-enabled patient engagement application, the KinexConnect App, to be used in conjunction with a continuous passive motion (CPM) machine.

Arms & Interventions

Arms

Experimental: KinexConnect

Rehab at Home Patients

Active Comparator: Outpatient PT

In-person PT patients

Interventions

Behavioral: - Telerehabilitation using the KinexConnect system for rehabilitation after TKA.

KinexConnect subjects are asked to Perform CPM therapy for 4 weeks. Perform a KCK home exercise program (HEP) for 6 weeks.

Behavioral: - Traditional outpatient PT for rehabilitation after TKA.

Control subjects are asked to undergo standard outpatient physical therapy (PT) with a licensed physical therapist plus supplemental home exercises as directed. Nominally patients are expected to have 3 PT sessions per week for 4 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Des Moines Orthopedic Surgeons, Des Moines, Iowa

Status

Recruiting

Address

Des Moines Orthopedic Surgeons

Des Moines, Iowa, 50266

Site Contact

Amy Knight, CST

[email protected]

515-224-1414