Healthcare Provider Endorsements

Dr. S. David Stulberg, M.D. – Northwestern University in Chicago, IL

As an orthopedic surgeon of 43 years, I am pleased to comment on the value of the TracPatch Knee technology that I have experienced during the clinical trial that I am currently carrying out. This trial has, thus far, carried out over 40 patients who underwent a primary total knee replacement. The goal of the trial was to determine the value of the TracPatch device to the performance of knee replacement surgery.

The device has been extremely well received by the initial group of 40 patients. They found the device very helpful in the first phase of their recovery. Patients felt that the exercises that they were being asked to carry out could be performed easily, effectively, and efficiently. Those patients that have had previous total knee procedures felt that their recovery was faster and more productive than they had experienced. The feedback from the device and the interaction with the health care team, made possible by TracPatch, was very helpful in allowing patients to reach their recovery goals. The device was easy to use by a wide range of patients. Many expressed the opinion that they would not like to have a knee replacement without the help of the TracPatch device.

I, personally, found the ability to monitor remotely in real-time progress and safety of the patients very helpful. I could quickly identify patients who needed special attention, as well as those that could proceed with their recovery without the intensive therapy usually prescribed in the post-surgical period. There is no doubt in my mind that the type of surveillance made possible by TracPatch will become the standard of care in the near future. The potential for achieving superior outcomes more effectively and efficiently will be an invaluable addition to the knee replacement surgeon’s armamentarium. Moreover, the data obtained by the device, when assembled for large numbers of patients, will be invaluable to the healthcare system.

Dr. Jeffrey Mandume Kerina, M.D. – Leesburg Regional Medical Center in Leesburg, FL

I have been involved in outpatient medicare arthroplasty surgery since 2008/2009. This has involved unicondylar knees to date in the medicare population. I have been involved in hospital based outpatient arthroplasty (Total knee/Total Hip) for the last three years.

The key to success in the outpatient arthroplasty arena is surveillance. The ability to detect changes in the patients post-operative course that may indicate inflection points that signal the need for intervention. The key lies in aligning the patients triage or “flow” through the pre-operative, peri-operative and post-operative periods. Establishing a patient baseline before intervention ,which allows you to truly identify variances from the SPECIFIC PATIENTS baseline is key. Every data point must be patient specific.

I started using the TracPatch device for my outpatient Unicondylar knees in Dec. 2018 and have already seen the real benefit to my patients in the form of improved outcomes secondary to improved real time intervention. When patients see a functioning device applied to them they become more directly engaged. We place the device 2 weeks preoperatively to establish the TRUE patient baseline The patient is then tracked for 6 weeks to 3 months post-op.

Example 1:

Patient’s baseline data revealed excellent engagement and performance. Initially had excellent progression in ROM and activity level. Day 4 noticed decrease in activity and ROM but no complaints from the patient. patient contact was made, pt c/o mild increased swelling of the knee, blood work showed over anticoagulation with elevated INR. Immediate modification of anticoagulation program was undertaken. Patient continued with postoperative program with complete resolution of symptoms. Without TracPatch this issue often results in severe hemearthrosis needing readmission, evacuation of hematoma and modification of anticoagulation. More importantly the patient outcome is often compromised long term.

Example 2:

Unicondylar knee, patient was undergoing post op exercise regimen, 5 weeks post-op had decrease in maximum flexion ROM with maintenance of extension and an aching pain with limits of flexion. Data flow evaluation showed engaged pre-operative patient participating with maximal effort in the postoperative recovery regimen. Accelerated clinical evaluation showed no clinical signs of infection or hemearthrosis. A 7-10 degree loss of terminal flexion was noted, although maximum flexion was still 128 degrees. Patient diagnosed with diagnosed with post-operative ankylosis most likely due to aggressive engagement in postoperative regimen. The Patient had early outpatient manipulation under anesthesia with 10 successive days of rehabilitation. A Complete resolution of symptoms and restoration of earlier postoperative range of motion was accomplished.

The data consistency of the TracPatch, based on its ability to generate data points in real time directly from the effected limb, has allowed us to develop a much more granular and effective post op triage algorithm incorporating thresholds for changes in range of motion and sustained postoperative exercise effort. This has given us the ability to more effectively train our postoperative provider partners and diminish the provider variances in our protocols.

In the nine months since I have incorporated the TracPatch into the outpatient service line it has shown significant potential to impact:

  1. Patient Engagement / Satisfaction
  2. Patient Outcomes
  3. Postoperative Cost Profile
  4. Provider Engagement / Education and Workflow

It is obvious that more data, analysis and research will be necessary to prove these early relatively anecdotal experiences. My point is that the current observations warrant that changes be made to prove or disprove the observations since the shift to value based medicine and therefore outpatient arthroplasty has taken root. We as specialty providers deserve all the tools necessary to ensure the safety and wellbeing of our patients as we navigate this new paradigm.

Dr. Ronald M. Gardner, M.D. – Lee Memorial Hospital in Ft Myers, FL

As an orthopedic surgeon for the last 30 years, it has always been frustrating to see the subjectivity that studies and reports and papers rely on.  The TracPatch option will add heretofore unavailable undeniable objectivity moving forward for those that utilize it to allow us to compare techniques and products.  As a clinician I look forward to being able to monitor patient’s progress remotely to know if they are compliant, making progress, have had a fall, or might be showing early signs of a complication (infection, for instance).  I believe that this will allow us to utilize resources as needed and not across the board and that should realize cost savings to the system.  I believe that the data is showing its use can reduce recovery time and produce earlier return to work dates and earlier “graduation” from therapy and home health all achieving better outcomes and cost reductions.  I understand that the desired process is to get a “pass through payment” approval to allow this product to be widely used and I would endorse that to not only assist us in the specific patient customization of care but with a growing data base I would expect that underperforming implants and procedures would be revealed and eliminated to benefit all concerned.

Current Partnerships and Clinical Studies