REDUCING PAIN FOR KNEE OSTEOARTHRITIS IN GERMANY (STUDY RESULTS)

Digitalization of healthcare, Germany is taking the lead
The digitization of healthcare is one of the most important topics nowadays. After the COVID pandemic erupted, many countries started to speed up the adoption of digital technologies. Finding solutions for such a complex challenge wasn’t going to be done overnight. Some countries did only the small steps towards the new way, but others did more than that. Germany was among the few which started building the regulatory frameworks way before the pandemic struck. In order to improve the medical outcomes, efficiently utilize human resources and save costs, the German healthcare public bill needed special care, being the largest in Europe with 410 billion Euro in 2019.
This is why the DiGA regulation had a very good timing and it is already generating evidence. However, in the broader scope, the challenges of introducing the digital solutions in the whole German public healthcare ecosystem is something which will require a lot of effort over the coming years. The DiGA allows patients to use the innovative digital solutions which were prescribed by their doctors, in order to get better treatment options and medical companies have an easier way of aligning to the standards. In the background, DiGA is evaluating many digital options and supporting them to meet all requirements in terms of privacy, data security, medical outcomes and more. But before seeing substantial adoption and good numbers, the need for in depth medical evidence will be a priority. This means understanding how patients interact with the digital tools, their outcomes and the selection criteria.
A team from Sporlastic and one from re.flex met with the Tubingen University and worked closely together in order to achieve the fully onboarded digital assisted protocol. The method should apply to as many patients as possible and start from an easy difficulty level and progress towards high intensity. Adding more sovereignty in the treatment, patients needed to be able to access alternative exercises and get effective adaptations throughout the course of the treatment.
Fig 1: Tubingen University, Sporlastic and re.flex first meet-up
Using the understanding and knowledge in exercise science gathered in more than 50 years of research from Tubingen University, we concluded over a 12-week exercise protocol. With 3 sessions per week, each lasting between 25-30 minutes focused on meeting strengthening, mobility, stretching and balance goals.
Instead of 12 in-clinical sessions, of 30 minutes each, patients are empowered to access a 90 days treatment with 3 sessions of physical therapy per week. With no additional costs added to the public reimbursement, we managed to keep 500 Euro cap-fee while improving the medical outcomes and reducing the out-of-pocket costs. In the long run, this approach has the potential to reduce or postpone the number of total knee and hip replacement surgeries
A randomized controlled study: 61 patients with medium to advanced knee Osteoarthritis
Delivering the study design was challenging. Aligning the needs of the German regulators with the business development strategy developed with Sporlastic, plus the medical team’s needs required a combined effort which translated into hundreds of hours of work.
re.flex Knee&Hip OA product was studied in a randomized control trial (RCT). 309 persons were assessed for eligibility. Patients were aged around 60 years old, suffering from medium or advanced knee or hip osteoarthritis. Finally we involved 61 patients: 31 to control group, 15 to study group A and study group AB. Study group A used the Sporlastic – re.flex smart rehabilitation brace, while group B exercised with the re.flex stand alone version.

Fig. 2 Eligibility criteria for the systematic review (PICOS-Scheme)

re.flex recorded a 90% overall adherence. More efficient in reducing pain than most common painkillers

The results from the Tubingen Study were very good and the positive health impact of the patients was significant. In terms of adherence, we’ve observed that in total, 75% of the training sessions were done and with an exercise repetition adherence of 90.25% and more.
This resulted in significant positive health outcomes for pain and physical function.

This is how the difference looks like, considering the KOOS sub scale for the assessment of pain

Fig. 3: With a blue line the results recorded by re.flex. With red the results of the current standard of care

Another important aspect to note is that achieving the results was done with no or only minor human intervention. Patients received the required treatment, only minor customization were remotely assessed. The overview of the patient’s compliance resulted below.
Fig 4: The classification of adherence showing the largest part with patients fully compliant
Next steps: building more evidence for Hip Osteoarthritis and ACL post-surgery!

re.flex will continue the integration in Germany by exploring other areas such as Hip Osteoarthritis, in another trial set to be conducted by a team from Tubingen University.

A third research project will be conducted by a team from Charite University Hospital, in Berlin, and will involve patients recovering after an ACL reconstruction surgery.

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re.flex team