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Non-operative treatment of unicompartmental osteoarthritis of the knee: a prospective randomized trial with two different braces—ankle–foot orthosis versus knee unloader brace

  • Orthopaedic Surgery
  • Published:
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Abstract

Background

The use of an unloader brace is a non-surgical treatment option for patients with medial osteoarthritis (OA). However, many patients do not adhere to brace treatment, because of skin irritation due to the pads at the level of the joint space and bad fit. A new concept to unload the medial compartment of the knee is a foot ankle brace with a lever arm pressing the thigh in valgus. The aim of this prospective randomized trial was to examine the outcomes of patients with medial OA after treatment with a conventional knee unloader brace (Unloader One®) and the new foot ankle orthosis (Agilium FreeStep®).

Methods

For this multicenter trial, 160 patients (> 35 years) with medial OA were randomly allocated to treatment with a conventional knee unloader brace (Unloader One®) or treatment with the new knee OA ankle brace (Agilium FreeStep®). The primary outcome measure was pain (numerical analog scale) at baseline (T0), 8 weeks (T1), and 6 months (T2). Secondary outcome measures were knee function (Knee Injury and Osteoarthritis Outcome Score, KOOS), side effects, additional interventions, and compliance.

Results

In both groups, walking pain improved between T0 and T1 and also between T0 and T2 without a significant group difference. For pain at sports, both groups showed a significant improvement between T0 and T2 without a significant group difference. The KOOS subscales symptoms, pain, activity, sport, and quality of life increased significantly in both treatment groups without any significant group differences at T 0, T1, and T2. There was also no significant group difference in additional interventions and weekly or daily brace use. In the Agilium FreeStep® group (23.5%), significantly less patients reported bruises in contrast to the Unloader One® group (66.7%).

Discussion

The results of this clinical trial show that the foot ankle brace is as effective as a conventional knee unloader brace for the treatment of medial knee OA with regard to clinical outcome. The rate of side effects such as bruises was significantly lower in the Agilium FreeStep® group.

Trial registration

DRKS00009215, 13.8.2015.

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References

  1. Amin S, Luepongsak N, Mcgibbon CA (2004) Knee adduction moment and development of chronic knee pain in elders. Arthritis Rheum 51:371–376

    Article  PubMed  Google Scholar 

  2. Briggs KK, Matheny LM, Steadman JR (2012) Improvement in quality of life with use of an unloader knee brace in active patients with OA: a prospective cohort study. J Knee Surg 25(5):417–421

    Article  PubMed  Google Scholar 

  3. Brouwer RW, van Raaij TM, Verhaar JA, Coene LN, Bierma-Zienstra SM (2006) Brace treatment for osteoarthritis of the knee: a prospective randomized multi-centre trial. Osteoarthr Cartil 14:777–783

    Article  CAS  Google Scholar 

  4. Brouwer RW, Jakma TS, Bierma-Zeinstra SM, Ginai AZ, Verhaar JA (2003) The whole leg radiograph: standing versus supine for determining axial alignment. Acta Orthop Scand 74:565–568

    Article  PubMed  Google Scholar 

  5. Creaby MW, Wang Y, Bennell KL (2010) Dynamic knee loading is related to cartilage defects and tibial plateau bone area in medial knee osteoarthritis. Osteoarthr Cartil 18:1380–1385

    Article  CAS  Google Scholar 

  6. Fantini Pagani CH, Potthast W, Brüggemann GP (2010) The effect of valgus bracing on the knee adduction moment during gait and running in male subjects with varus alignment. Clin Biomech (Bristol Avon) 25(1):70–76

    Article  Google Scholar 

  7. Fantini Pagani CH, Hinrichs M, Brüggemann GP (2012) Kinetic and kinematic changes with the use of valgus knee brace and lateral wedge insoles in patients with medial knee osteoarthritis. J Orthop Res 30(7):1125–1132

    Article  PubMed  Google Scholar 

  8. Fantini Pagani CH, Willwacher S, Benker R, Brüggemann GP (2014) Effect of an ankle-foot orthosis on knee joint mechanics: a novel conservative treatment for knee osteoarthritis. Prosthet Orthot Int 38(6):481–491

    Article  PubMed  Google Scholar 

  9. Jones RK, Chapman GJ, Parkes MJ, Forsythe L, Felson DT (2015) The effect of different types of insoles or shoe modifications on medial loading of the knee in persons with medial knee osteoarthritis: a randomised trial. J Orthop Res 33(11):1646–1654

    Article  PubMed  PubMed Central  Google Scholar 

  10. Kellgren JH, Lawrence JS (1957) Radiological assessment of osteoarthrosis. Ann Rheum Dis 16:494–502

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Komistek RD, Dennis DA, Northcut EJ, Wood A, Parker AW, Traina SM (1999) An in vivo analysis of the effectiveness of the osteoarthritic knee brace during heel-strike of gait. J Arthroplasty 14(6):738–742

    Article  CAS  PubMed  Google Scholar 

  12. Lewek MD, Rudolph KS, Snyder-Mackler L (2004) Control of frontal plane knee laxity during gait in patients with medial compartment knee osteoarthritis. Osteoarthr Cartil 12:745–751

    Article  Google Scholar 

  13. McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M (2014) OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthr Cartil 22(3):363–388

    Article  CAS  Google Scholar 

  14. Menger B, Kannenberg A, Petersen W, Zantop T, Rembitzki I, Stinus H (2016) Effects of a novel foot-ankle orthosis in the non-operative treatment of unicompartmental knee osteoarthritis. Arch Orthop Trauma Surg 136(9):1281–1287

    Article  PubMed  PubMed Central  Google Scholar 

  15. Miyazaki T, Wada M, Kawahara H (2002) Dynamic load at baseline can predict radiographic disease progression in medial compartment knee osteoarthritis. Ann Rheum Dis 61:617–622

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Moyer RF, Birmingham TB, Bryant DM, Giffin JR, Marriott KA, Leitch KM (2015) Valgus bracing for knee osteoarthritis: a meta-analysis of randomized trials. Arthritis Care Res (Hoboken) 67(4):493–501

    Article  Google Scholar 

  17. Petersen W, Achtnich A, Lattermann C, Kopf S (2015) The treatment of non-traumatic meniscus lesions. Dtsch Arzteblatt Int 112:705–713

    Google Scholar 

  18. Petersen W, Ellermann A, Zantop T, Rembitzki IV, Semsch H, Liebau C (2016) Best biomechanical effect of unloader braces for medial osteoarthritis of the knee: a systematic review (CRD 42015026136). Arch Orthop Trauma Surg 136(5):649–656

    Article  PubMed  PubMed Central  Google Scholar 

  19. Pollo FE, Otis JC, Backus SI, Warren RF, Wickiewicz TL (2002) Reduction of medial compartment loads with valgus bracing of the osteoarthritic knee. Am J Sports Med 30(3):414–421

    Article  PubMed  Google Scholar 

  20. Ramsey DK, Russell ME (2009) Unloader braces for medial compartment knee osteoarthritis: implications on mediating progression. Sports Health 8:416–426

    Article  Google Scholar 

  21. Ramsey DK, Briem K, Axe MJ, Snyder-Mackler L (2007) A mechanical theory for the effectiveness of bracing for medial compartment osteoarthritis of the knee. J Bone Jt Surg Am 89(11):2398–2407

    Google Scholar 

  22. Roos EM, Lohmander LS (2003) Knee injury and osteoarthritis outcome score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes 1:64–69

    Article  PubMed  PubMed Central  Google Scholar 

  23. Schipplein OD, Andriacchi TP (1991) Interaction between active and passive knee stabilizers during level walking. J Orthop Res 9:113–119

    Article  CAS  PubMed  Google Scholar 

  24. Self BP, Greenwald RM, Pflaster DS (2000) A biomechanical analysis of a medial unloading brace for osteoarthritis in the knee. Arthritis Care Res 13(4):191–197

    Article  CAS  PubMed  Google Scholar 

  25. Schmalz T, Blumentritt S, Drewitz H, Freslier M (2006) The influence of sole wedges on frontal knee plane kinetics, in isolation and in combination with representative rigid and semi-rigid ankle–foot-orthoses. Clin Biomech 21:631–639

    Article  Google Scholar 

  26. Sharma L, Lou C, Felson DT, Dunlop DD, Kirwan-Mellis G, Hayes KW, Weinrach D, Buchanan TS (1999) Laxity in healthy and osteoarthritic knees. Arthritis Rheum 42:861–870

    Article  CAS  PubMed  Google Scholar 

  27. Sharma L, Song J, Felson DT, Cahue S, Shamiyeh E, Dunlop DD (2001) The role of knee alignment in disease progression and functional decline in knee osteoarthritis. JAMA 286:188–195

    Article  CAS  PubMed  Google Scholar 

  28. Squyer E, Stamper DL, Hamilton DT, Sabin JA, Leopold SS (2013) Unloader knee braces for osteoarthritis: do patients actually wear them? Clin Orthop Relat Res 471(6):1982–1991

    Article  PubMed  PubMed Central  Google Scholar 

  29. van Raaij TM, Reijman M, Brouwer RW, Bierma-Zeinstra SM, Verhaar JA (2010) Medial knee osteoarthritis treated by insoles or braces: a randomized trial. Clin Orthop Relat Res 468(7):1926–1932

    Article  PubMed  PubMed Central  Google Scholar 

  30. Wilson B, Rankin H, Barnes CL (2011) Long-term results of an unloader brace in patients with unicompartmental knee osteoarthritis. Orthopedics 34(8):e334–e337

    PubMed  Google Scholar 

Download references

Acknowledgements

Funding was provided by Otto Bock Health Care.

Author information

Authors and Affiliations

  1. Klinik für Orthopädie und Unfallchirurgie, Martin Luther Krankenhaus, Grunewald, Caspar Theyß Strasse 27-31, 14193, Berlin, Germany

    Wolf Petersen

  2. Arcus Sportklinik, Rastatter Straße 17, 75179, Pforzheim, Germany

    Andree Ellermann

  3. Krankenhaus Lahnhöhe, Zentr. für konserv. Orthopädie, Am Kurpark 1, 56112, Lahnstein, Germany

    Jörg Henning

  4. Donau Universität Krems, Dr. Karl Dorrek Straße 30, 3500, Krems, Austria

    Stefan Nehrer

  5. Deutsche Sporthochschule Köln, Cologne, Germany

    Ingo Volker Rembitzki

  6. Orthopädisch Chirurgisches Centrum Tübingen, Wilhelmstr. 134, 72074, Tübingen, Germany

    Jürgen Fritz

  7. Orthopädische Klinik der MH Hannover, Anna-von-Borries-Straße 1-7, 30625, Hannover-Kleefeld, Germany

    Christoph Becher

  8. FISIOTERAPIA Albasini and Müller, Viale Giuseppe Motta 15, 6500, Bellinzona, Switzerland

    Alfio Albasini

  9. St. Vinzenz Hospital-Dinslaken, Dr. Otto-Seidel Str. 31, 46535, Dinslaken, Germany

    Wolfgang Zinser

  10. Gelenk und Wirbelsäulenzentrum, Kieler Str. 1, 12163, Berlin, Germany

    Volker Laute

  11. Gemeinschaftspraxis Rosenthal and Schubert, Viktoriastr. 66-70, 44787, Bochum, Germany

    Klaus Ruhnau

  12. Orthopaedicum Northeim, Sturmbäume 3, 37154, Northeim, Germany

    Hartmut Stinus

  13. Asklepios Harzklinik Fritz-König-Stift, Ilsenburger Straße 95, 38667, Bad Harzburg, Germany

    Christian Liebau

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  1. Wolf Petersen
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Correspondence to Wolf Petersen.

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Petersen, W., Ellermann, A., Henning, J. et al. Non-operative treatment of unicompartmental osteoarthritis of the knee: a prospective randomized trial with two different braces—ankle–foot orthosis versus knee unloader brace. Arch Orthop Trauma Surg 139, 155–166 (2019). https://doi.org/10.1007/s00402-018-3040-8

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