Kolenní ortéza pro osteoartritidu kolene Odra

Ortéza pro osteoartritidu kolene Odra je navržena pro symptomatickou léčbu osteoartritidy mediálního femorotibilálního oddílu.

Morfologická

Ortotik vyrobí kolenní ortézu na základě otisku nebo pomocí digitálního skenovacího zařízení s cílem dosáhnout perfektního dosednutí přes dolní končetinu pacienta.

Unikátní a patentovaný mechanismus účinku

Ortéza Odra vyvinutá společností PROTEOR a patentovaná po celém světě zlepšuje mobilitu udržováním mezery mezi kostmi horní a spodní části dolní končetiny. Tato redukce intraartikulárního tlaku tlumí bolest, ke které dochází při absenci chrupavky třením těchto kostí o sebe.

Název ortézy Odra popisuje její funkci: Ortéza používající Didstrakci (tah) a Rortaci k úlevě od Artritidy.

Mediální distrakce: při extenzi dolní končetiny, během stoje dochází k prodloužení ortézy mediálním pantem, což navozuje ODTAŽENÍ mezi femurem a tibií. Toto prodloužení snižuje tlak na bolestivou část kolene.

Vnější rotace: souběžně s touto distrakcí se osa laterálního pantu posune dozadu, což vede k vnější ROTACI nohy. Tato rotace vyvažuje abdukční pohyb, který může vést k bolestivému zúžení kloubního prostoru.

Dynamická ortéza

Kolenní ortéza působí na koleno pouze při natažené dolní končetině, tzn. když je pacient aktivní.

Dobře tolerovaná s cílem zajistit dobrou shodu

Jedním ze zjištění klinického hodnocení ERGONOMIE vedeného ve Francii byla skutečnost, že ortéza byla nošena v průběhu >5 h/denně, 6 dní v týdnu. To odpovídá pokynům poskytovaným pacientům při zařazení (6 h/den).

Vědecky doložená účinnost

Několik nezávislých a mezinárodně uznávaných studií dokázalo účinnost ortézy Odra. Některé klíčové závěry těchto studií jsou uvedeny níže:


Xavier Robert-Lachaine, et al, Three‐month efficacy of three knee braces in the treatment of medial knee osteoarthritis in a randomized crossover trial (access the abstract: click here

Conclusions of the study: 

  • All three orthoses relieved pain and stiffness and improved functional status and quality of life.
  • Compared with the two other types of orthosis, the Odra custom-made orthosis was more comfortable, encouraged a higher level of treatment compliance and induced a greater reduction in KAM (knee adduction moment).

Ornetti P, et al, Clinical effectiveness and safety of a distraction-rotation knee brace for medial knee osteoarthritis, Annals of Physical and Rehabilitation Medicine (access the study: click here)

The ERGONOMIE randomized control trial (coordinated by Dijon university hospital, 2015/2017) assessed 120 patients and demonstrated that use of the Odra orthosis significantly relieved pain, improved quality of life and encouraged a return to sporting activities.

Conclusions of the study: 

The ERGONOMIE RCT showed that the combination of Odra + usual care is a promising therapeutic strategy characterized by high levels of acceptance and tolerance by patients with medial knee osteoarthritis.

The overall improvement in KOOS scores in the Odra group showed that the patients’ overall function was improved by wearing the device for one year. There was also a clear improvement in 3 domains in the OAKHQOL questionnaire for the Odra group.

The ERGONOMIE RCT thus demonstrated a significant improvement in pain and function in the Odra group vs the usual care alone group.
The results confirm that the device is safe to use and suggest that its use is associated with a good cost-effectiveness ratio.

Although some side effects were reported, the high level of treatment compliance after wearing the device for one year reveals good medium-term tolerance. The estimated percentage of patients who continued to use the orthosis daily at 1 year was particularly high (84%) compared with other studies found in the literature.

From a societal perspective, Odra has a cost-utility ratio that has not so far been demonstrated for any other orthosis used to treat medial knee osteoarthritis.
The patients in the usual care alone group were offered the opportunity to try out the Odra orthosis at the end of the trial.

Ornetti P & Al, Clinical effectiveness and safety of a distraction-rotation knee brace for
medial knee osteoarthritis, Annals of Physical and Rehabilitation Medicine (access the abstract: click here)

Conclusions of the study:

The results of this study demonstrate the short- and medium-term effectiveness of the Odra custom-made orthosis with regard to relieving pain and improving function
The Odra orthosis appears to have a Benefit-Risk ratio that is better than those of the reference orthoses (unloader braces, three-point braces, etc.)

Dessery Y, et al, Comparison of three knee braces in the treatment of medial knee osteoarthritis, Knee (access the abstract: click here)

Conclusions of the study: 

  • Reduction in the mechanical loading on the knee joint;
  • Wearing the orthosis immediately alleviates knee pain;
  • The Odra brace was more comfortable to wear than the other orthoses.

Laroche D, et al, Biomechanical effectiveness of a distraction–rotation knee brace in medial knee osteoarthritis: Preliminary results, Knee (access the abstract: click here)

Conclusions of the study: 

Wearing the distraction-rotation orthosis (Odra) significantly improved functional status and gait in the short term (less than 2 months).
The study provides additional objective proof to support the arguments in favour of the utility of orthoses in improving gait and treating medial knee osteoarthritis.

Indikace

Ve Francii jsou náklady na ortézu ODRA hrazeny z veřejného zdravotního pojištění jako položka „grand appareillage“. Ortéza je vyráběna na základě otisku nebo snímků digitálního skenovacího vybavení a následně upravována ortotikem.

Tuto ortézu mohou předepisovat ortopedičtí chirurgové, rehabilitační lékaři nebo revmatologové.

  • Osteoartritida mediálního kolene (stupeň I až IV);
  • Všechny osoby s diskomfortem během denních aktivity (chůze do schodů a ze schodů, nakloněné roviny atd.) a při cvičení (turistika, chůze atd.);
  • Všechny osoby, které již nemohou užívat antiflogistika nebo které mají problémy při jejich užívání
  • Všechny osoby čekající na operaci kolene.

Kontraindikace

Problémy s povrchovými žílami, pacienti s výrazněji postiženým laterálním kompartmentem kolene než mediálním, velmi výrazná hyperextenze kolene.

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Otázky/odpovědi

No, its mechanical operation has been specifically designed to provide relief to those with MEDIAL knee osteoarthritis; however, this accounts for >85% of the population.

Yes, the Odra is effective on patients who weigh more than they would like to. In fact, overweight is one of the risk factors for knee osteoarthritis.

 The orthosis is custom made to ensure that an optimal fit is achieved. 

Since the alleviation of pain encourages the wearer to become more physically active, patients often have arrange to see their orthotist again to readjust their orthosis to accommodate the weight loss.

Yes, this is not a contraindication for anyone.

You can engage in various low-impact activities or sports such as walking, golf, cross-country skiing, bowling and gardening. A sedentary lifestyle accelerates the course of osteoarthritis and needs to be avoided.

High-intensity sports such as downhill skiing, jogging, basketball, etc. are not recommended since they place high stresses on the joints.

Certainly, no problem. In fact, this is often the case, since 2/3rds of people with KOA have problems with both knees. 

The orthotist must, however, be particularly careful when fitting the orthoses to ensure that they do not rub against each other.

No, the distraction simply counters the natural compression of the knee to “unload” (or reduce the pressure) on the medial compartment.

No, the Odra must be fitted next to the skin to avoid slipping and for optimal effectiveness.

You will receive instructions from the orthotist about how to position the Odra, and you will also be given an instructions for use leaflet. You should sit down when fitting the Odra, with your knee bent at 90°. 

For optimal fastening, PROTEOR has fitted quick-release buckles to the Odra so that the strap tightness selected by the orthotist is achieved automatically and to make it easier for you to position the Odra correctly when putting it on.

No, you should only wear it when you feel you need to (to avoid pain) or if you are planning to be physically active.

No, the Odra is a dynamic orthosis. It is only effective when you are moving around.

There is no contraindication for this.

Yes, the Orfèvre study revealed that patients wearing the device took significantly less medication (evidence of the reduction in pain levels).

No study has confirmed that the Odra orthosis slows down the progression of osteoarthritis. 

What has been proven is that since the orthosis alleviates pain when moving, it lets patients break the vicious circle of their condition worsening as a result of their sedentary lifestyle. 

Yes, in fact this is an important indication considered when prescribing the Odra.