TracPatch in Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Total Knee Arthroplasty is becoming an increasingly common operation. An important part of a successful overall patient outcome is regaining functional range of motion after surgery. Wearable devices for fitness have become increasingly common. This study seeks to utilize wearable technology to enhance the post-operative rehabilitation experience by allowing patients and surgeons to monitor patient recovery in real time. The Consensus TracPatch is a wearable device which utilizes an accelerometer, temperature sensor and step count to monitor patient recovery. This tool provides critical, real-time information that may offer a more complete source of data to understand a patient's postoperative clinical and rehabilitation course and guide physician postoperative management. The study hypothesizes that this new technology will improve patient postoperative mobility and patient-physician communication.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Telemedicine in Total Knee Arthroplasty Using Wearable Technology

NCT03406455

Knee Arthritis

COMPLETED

Using a Smart Implantable Device to Compare Early Recovery in Two Different Knee Arthroplasty Approaches

NCT07348835

Total Knee Anthroplasty

NOT_YET_RECRUITING NA

ROM Outcomes in Patients Undergoing a Primary TKA

NCT04217486

Knee Osteoarthritis

COMPLETED NA

Evaluating the Feasibility and Effectiveness of Using a Smartphone Application During Rehabilitation in Patients After Total Knee Replacement

NCT05434767

Total Knee Replacement Total Knee Arthroplasty

COMPLETED NA

Using a Smartphone App to Aid in Functional Mobility Return Following Total Knee Arthroplasty

NCT03607461

Total Knee Arthroplasty

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthroplasty, Replacement, Knee Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients who meet enrollment criteria will be randomized to either the treatment group where they will receive their consensus tracpatch or be assigned to the control group where no wearable technology will be employed.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wearable Technology Group

Patients in this arm will be provided with their own Consensus TracPatch wearable device postoperatively and instructed on its use for six weeks.

Group Type EXPERIMENTAL

Consensus TracPatch

Intervention Type DEVICE

Consensus TracPatch will be attached to the participant's shin approximately two inches below the knee through use of an adhesive strip similar to a standard bandage for 6 weeks after total knee arthroplasty.

Current Standard of Care Group

Patients in this arm will not be provided with any wearable device. Participants will be evaluated as part of the study for a total of six weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Consensus TracPatch

Consensus TracPatch will be attached to the participant's shin approximately two inches below the knee through use of an adhesive strip similar to a standard bandage for 6 weeks after total knee arthroplasty.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Surgical candidate for total knee arthroplasty
* Greater than 18 years of age
* Have signed the written informed consent form
* Have consistent access to an iOS or Android device with Bluetooth capability

Exclusion Criteria

* Unwilling or unable to provide consent
* Not fluent in the language of the informed consent form (English and Spanish)
* Prisoners
* Pregnant women
* Wards of the state
* Have previously undergone a TKA on that ipsilateral knee
* Deformities of \> 10 degrees valgus or varus or flexion contractures of \> 10 degrees.
* Considered by the surgeon to be a complex arthroplasty

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No