In short
A non-interventional, multi-center study with 113 patients with osteoarthritis of the knee shows that the GenuTrain OA knee brace helps to significantly reduce pain and that it promotes a high level of compliance.
The average treatment duration of 5 weeks resulted in clinically meaningful pain reduction and an increase in the patients’ sense of stability and mobility.
The majority of test subjects were positive about the handling, fit and comfort of the relieving knee brace.
Physicians rated the achievement of their prioritized treatment goals with the GenuTrain OA as ‘good’ on average: pain reduction (2.0), knee relief (2.2), stabilization (1.87).
In his interview, Adjunct Professor Dr. Philip Rößler from the participating Gelenkzentrum Mittelrhein joint center confirmed that pain reduction is the most important treatment goal in cases of osteoarthritis of the knee, which can be effectively achieved with the GenuTrain OA.
Knee problems are no longer a reason for withdrawing from living an active life because there are medical aids that alleviate pain. Nowadays, osteoarthritis is not merely a question of age and wear but also of lifestyle. Osteoarthritis of the knee is less daunting when physicians and patients find a way together to actively combat the pain. Patients’ individual strengths, not their weaknesses, are important to ensure activity, sports and social participation become possible again. A modern medical aid like the GenuTrain OA helps to achieve this goal. This has been confirmed by physicians, physical therapists from Germany, France, and Canada, as well as more than 100 patients in a recent study using the relieving brace.
[bauerfeind_spoiler title=”Case series with 113 patients with osteoarthritis of the knee: GenuTrain OA brings physicians and patients closer to their goal”]
A multi-center study about the effect and therapeutic safety of the GenuTrain OA has confirmed the following: the knee brace significantly reduces pain in a clinically meaningful way – and it is well accepted by patients.
Osteoarthritis is one of the biggest orthopedic challenges of our time. Worldwide estimates are that one in ten men and one in five of women over the age of 60 years have symptomatic osteoarthritis. The condition most commonly affects the knee joint. Radiographic evidence of knee osteoarthritis is present in approximately 30 percent of men and women over the age of 65.1 In addition to increasing age, obesity and inactivity are the main causes of the condition.2 Besides physical symptoms, however, osteoarthritis of the knee can also have other serious consequences. Pain and immobility are often coupled with withdrawal from an active and social lifestyle.3 Withdrawal that does not have to be inevitable.
Eliminating the fear of activity
The fear of movement and pain becomes unfounded when patients realize what possibilities are open to them, thanks to braces that provide targeted relief. In cases of medial or lateral osteoarthritis of the knee, pain can be reduced that would otherwise nip any kind of urge to move in the bud. The affected compartment (usually the medial) is relieved during this process. In the currently applicable S2k ‘Osteoarthritis of the Knee’ Guidelines specified by the German Society for Orthopedics and Orthopedic Surgery (DGOOC), appropriate braces are recommended to provide targeted relief as part of non-surgical care.4
Basic study data n = 113 patients (59% ♀, 41% ♂), Age: Ø 64.4 years Test brace: GenuTrain OA Treatment duration: Ø 5.4 weeks Type of treatment: non-surgical: 81%, post-operative: 16%, pre-operative: 3% Inclusion criteria: medial or lateral osteoarthritis of the knee Participating medical practices: 8 Evidence class: 3
Patients and treating experts evaluate the GenuTrain OA
In the non-interventional study “Evaluation of the effect and therapeutic safety of the GenuTrain OA knee brace”, 113 patients that were supervised by eight physicians evaluated the brace during treatment. The goal of the observational study was to gain information from patients about noticeable effects of the brace concerning the following parameters: pain, stability, mobility and pain-free walking distance (see Fig. 2). Additional data was collected from patients related to wearing characteristics, handling, and fit of the brace. These factors play a crucial role when it comes to compliance. The treating physicians were asked to give statements about the order of their treatment goals. It was subsequently checked whether they were achieved (see Fig. 1).
Significant and clinically meaningful pain reduction
Measured using the 10-point Visual Analog Scale (VAS), patients’ self-reported pain reduced to 3.4 when the GenuTrain OA was worn. This value had been 7 before the five-week treatment with the brace. The patients’ sense of stability improved from 3.8 to 7.3. The patients’ mobility increased from 3.2 to 6.9. This increase was also seen in the pain-free walking distance, which improved from 3.2 to 6.9 (see Fig. 2). Physicians stated the following as the most important treatment goals: joint relief (67 percent), stabilization (55 percent) and the restoration of normal patient mobility (29 percent). Pain reduction, however, was at the top of the treatment goal list, with 93 percent. Achieving this goal with the GenuTrain OA was rated at 2.00 (good) by physicians. Reaching the other treatment goals was rated between 1.87 and 2.20 (see Fig. 1).
Fig. 1: Treatment goal and its achievement as a result of being provided with the GenuTrain OA. More than one option could be selected. Fig. 2: Pain, stability, mobility and pain-free walking distance before treatment with the brace and after treatment with the brace (an average of 5.4 weeks), reported using the visual analog scale. Showing mean values with standard deviation; * p<0.001 (paired t-test)
High degree of patient compliance
Unilaterally relieving braces must be well accepted by patients and must be worn regularly, otherwise they cannot exert their effectiveness.5 Handling, fit, comfort and noticeable effect are crucial factors that determine the degree of compliance. Putting on the GenuTrain OA was described by 92 percent of patients as very easy, easy, or without difficulty. The fit was rated as excellent or good by 79 percent of patients. The degree of treatment support and confidence provided by the brace was rated by patients as 2.2 (good) on average. This combination of offering a good effect and good compliance makes the GenuTrain OA a valid treatment option for active patients who make high demands on their own mobility with, and in spite of, osteoarthritis of the knee. Selected results from the case series have been summarized in German and English in the digital white paper “Evaluation of the effect and therapeutic safety of the GenuTrain OA knee brace”. Available from medical.affairs@bauerfeind.com
GenuTrain OA®: Targeted relief for osteoarthritis of the knee
Providing relief where there is pain: the GenuTrain OA can be adjusted by the orthotist such that it removes pressure from the medial and lateral compartment. This redistribution of pressure helps to protect the affected areas of cartilage from excessive strain and to balance local shear forces more effectively. Patients suffering from osteoarthritis of the knee accept the lightweight, flexible brace well because it provides them with a lot of freedom of movement and they can adjust the relieving effect themselves. The GenuTrain OA provides relief according to the 3-point principle in cases of mild to moderate osteoarthritis of the knee, and supports a dynamic axis correction up to 10 degrees. It is made of elastic 3D knitted mesh with an integrated system for relief and stabilization. Thanks to extensive direct contact with the skin, the knee brace adapts to the patient’s leg very effectively. It even remains securely in position during quick movements. It is put on using a donning aid and does not require straps to close it. Using the integrated Boa® Fit System dial, patients can easily increase or reduce the tension provided by the guided relief straps. This controls the exerted force, and the relieving effect can be adapted to changing situations of strain without having to take off the GenuTrain OA.
1 Wittenauer R. et al. Background Paper 6.12 Osteoarthritis. Backgr. Pap. WHO, 2004 2 Safiri S. et al. Global, regional and national burden of osteoarthritis 1990 – 2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis, 2020; 79: 819 – 828. 3 Merx H, Dreinhöfer KE, Günther KP. [Socioeconomic relevance of osteoarthritis in Germany]. Zeitschrift für Orthopädie und Unfallchirurgie. 2007;145(4):421-9. 4 www.awmf.org/uploads/tx_szleitlinien/033-004l_S2k_Gonarthrose 5 Rogoschin J. Patientencompliance: Worauf legen Gonarthrose-Patienten bei der Auswahl von entlastenden Orthesen Wert? Orthopädie Technik 4/21
[bauerfeind_spoiler title=”Multi-modal treatment is required: Interview on the case series with Associate Professor Dr. med. Philip Rößler”]
As one of eight medical practices, Mittelrhein Joint Center contributed to the evaluation of the GenuTrain OA with its Medical Director Associate Professor Dr. med. Philip Rößler. The orthopedist also sees its use as a way to build trust.
Associate Professor Dr. med. Philip Rößler, Mittelrhein Joint Center
life: How would you rate the results of the study?
Dr. Rößler: Identifying pain reduction as the major treatment goal in cases of osteoarthritis of the knee is something I know from practical experience with my patients. Rating the achievement of the treatment goal with the GenuTrain OA as “good” also matches what I’ve experienced. An OA brace primarily provides pain reduction that is essentially generated by the unilateral relief and the redistribution of forces in the knee. Up to 80 percent of the body weight can rest on the inside of the joint. This pain does something to people. Even though the pain isn’t debilitating, patients get fed up with it quickly. What does the pain stop them from doing? That’s what we have to find out via a targeted medical history that suits the requirement. Many patients have lost trust in their knee because of this impairment. This is where talking medicine is required, of course. But just friendly words aren’t enough. You have to be able to offer something as well.
Something that quickly helps to reduce pain?
Dr. Rößler: Yes, if you mean the GenuTrain OA, but not exclusively. The brace is perfect because patients notice, “Hey, when I wear it, I can play tennis again.” But its use has to be embedded in physical and/or medication-based, multi-modal osteoarthritis treatment. We have to make patients understand this interaction, to create an individual plan in which the brace that can be adjusted by the patient plays a crucial role. Otherwise, the knee won’t benefit in the long term. Patients taking personal responsibility is important. At Mittelrhein Joint Center, we perform a good number of corrective osteotomies. Beforehand, I usually recommend to my patients that they wear the GenuTrain OA as a test. After that, some of them even say “That’s enough for me, I don’t need surgery after all.”
“An OA brace primarily provides pain reduction that is essentially generated by the unilateral relief and the redistribution of forces in the knee.”
Dr. med. Philip Rößler
So it’s about noticeable effects?
Dr. Rößler: Patients suffering from mono-compartmental osteoarthritis of the knee will benefit from a relieving brace, in whatever way. When they realize this, they will come to the next check-up appointment. I see them again, get feedback, and can influence their ongoing direction.
Is osteoarthritis of the knee what it used to be?
Dr. Rößler: We used to think that osteoarthritis was merely joint wear. The advice to patients used to be that those suffering from wear had to take it easy. We’ve moved on from that and know now that it’s actually the opposite because osteoarthritis isn’t just about wear. On the contrary, the inflammatory condition actually affects the entire joint: the membrane, the fluid, and the surrounding structures. Preserving maximum mobility with as little resistance as possible is therefore a basic concept nowadays. We have to motivate patients to get back to their previous level of activity. We see a lot of patients every day that get on really well with that. And we hear 70-year-olds complaining that they can no longer run marathons. That’s the new spectrum of orthopedic patients. And that’s where we have to start our treatment.
Images: Bauerfeind, Peter Seydel
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