Smart Total Knee Replacement for Healthcare Professionals

The Smart Total Knee Replacement is created to provide you with intelligent metrics after surgery, facilitate communication with your patients through The app Management of Healthcare platform, and be user-friendly with automatic data transfer and an easy-to-navigate interface.

Features

• Intelligent: A smart implant that captures crucial kinematic data metrics, which is the first of its kind in the world. The objective kinematic data serves as a supplement to other tools used by physicians to measure physiological parameters during the patient’s post-surgery monitoring and treatment.
• Linked: Enables access to patient-specific data for a minimum of ten years. Facilitates achieving patient compliance.
• Simple: The app Management of Healthcare platform offers an automatic and user-friendly interface that allows both patients and physicians to easily access long-term data. Keeps the standard Smart Total Knee Replacement surgery process and equipment unchanged.
• Data Protection: We recognize the significance of confidentiality and are committed to safeguarding that privilege. Our utilization of customer and patient data is limited to the fulfillment of agreed-upon services and for facilitating the provision of such services. The Smart Total Knee Replacement is not intended for patient location tracking, and Complete Orthopedics is committed to ensuring the safety of the data entrusted to us by employing robust protective measures.

System Information

The Smart Total Knee Replacement is an innovative knee implant that records significant walking pattern metrics, such as the functional range of motion (ROM) of the knee, step count, and average walking speed based on sampling.

This makes it the first smart implant of its kind in the world. With the use of sensor-based technology, the Smart Total Knee Replacement enables physicians and care teams to gather patient-specific data throughout the patient monitoring process.

• Rhythm of movement: Averaged number of steps taken per minute (steps/minute)
• Average pace of walking: Computed through the combination of stride length and step count (meters/second).
• Step distance: Computed based on a single walking cycle (in meters)
• Total distance covered: Computed through the combination of stride length and step count (in kilometers).
• Practical Range of Motion: Incorporating both the tibia and functional knee range of motion (degrees).
• Count of valid steps: amount of steps taken within a selected day of sampling.

The Smart Total Knee Replacement Comes Equipped With Recovery Curves

Healthcare professionals can leverage the Recovery Curves to compare a patient’s gait parameter data with that of similar patients. The Recovery Curves are graphical representations of the recovery trends observed within a cohort of patients at various percentiles, such as the 5th, 10th, 25th, 50th, 75th, 90th, and 95th, providing a benchmark for the patient’s progress post-operation.

Recovery Curves are available for the following manner of walking parameters:

• Walking speed
• Mobility Range
• Verified Step Count
• Step length
• Tibial Range of Motion
• Traveled distance
• Number of steps taken per minute

Recovery Curves provide a comprehensive analysis of a patient’s recovery by comparing their gait parameters to those of a similar age and gender population. This enables healthcare professionals to gain a better understanding of the patient’s progress.

Protected Data Transmission

The Smart Total Knee Replacement simplifies the process of collecting and using patient-specific data. The app Management of Healthcare provides an intuitive interface for both patients and physicians to view post-operative data, which is easily accessible through a simple and user-friendly system.

• Registration of Patients: A patient becomes eligible for the Smart Total Knee Replacement upon being approved by their surgeon.
• Implantation: Install and activate the Smart Total Knee Replacement implant.
• Transfer of data from one source to another: The data captured by the Smart Total Knee Replacement is transmitted to the patient’s Home Base Station and then uploaded securely to the cloud once every day.
• Recovery Monitoring: The app Management of Healthcare platform enables monitoring of post-operative recovery.

Smart Total Knee Replacement with the app Management of Healthcare Platform

Patients can receive support and guidance through a connected experience offered by the app, which collects various metrics. To participate, patients simply need to enroll.

• Encouragement and Instruction
• Activity and Physiologic Tracking without effort.
• Pain & Gait
• Exercises before and after surgery
• Remote medical consultation and communication through messaging

Indications

The extension in combination with the processor system aims to deliver precise kinematic data derived from the implanted medical device during the patient’s post-surgical care following total knee arthroplasty (TKA).

The kinematic data obtained from the extension with the processor system serves as a supplement to other physiological parameter measurement tools utilized by the physician for patient monitoring and treatment post-surgery.

The device is intended for patients who undergo a cemented TKA procedure and are typically recommended for a tibial stem extension of at least 58 mm in size.

The kinematic data produced by the extension with the processor system are not intended to be used as a basis for clinical decision-making and have not been demonstrated to provide any clinical advantage. The Complete Orthopedics Smart Total Knee Replacement is compatible with the extension with the processor system.

Contraindications

The use of the extension is not recommended for patients undergoing procedures or treatments involving therapeutic ionizing radiation in the vicinity of the device, as it may lead to a shortened battery life or premature failure of electronic components.

The extension may sustain damage from therapeutic ionizing radiation, which may not be promptly identifiable. Consider the following contraindications before conducting TKA on patients who have:

• Patients with a history of infection in the affected joint or other local/systemic infection that may impact the prosthetic joint should be evaluated carefully before undergoing TKA.
• The availability of inadequate bone stock on the femoral or tibial surfaces.
• Incomplete skeletal development or growth.
• Neuropathic arthropathy.
• The presence of osteoporosis or any condition that results in loss of musculature or neuromuscular function that compromises the affected limb.
• The patient should have a satisfactory functional position with a stable and painless arthrodesis.
• The presence of severe instability due to collateral ligament insufficiency.

Patients with rheumatoid arthritis (RA) who have a skin ulcer or a history of recurrent skin breakdown are contraindicated for Total Knee Arthroplasty due to an increased risk of postoperative infection.

Patients with RA who are using steroids may have an increased risk of infection, and late infections have been reported in RA patients more than 24 months postoperatively.