Medial Knee Osteoarthritis Treated by Insoles or Braces: A Randomized Trial
There is controversial evidence regarding whether foot orthoses or knee braces improve pain and function or correct malalignment in selected patients with osteoarthritis (OA) of the medial knee compartment. However, insoles are safe and less costly than knee bracing if they relieve pain or improve function.
We therefore asked whether laterally wedged insoles or valgus braces would reduce pain, enhance functional scores, and correct varus malalignment comparable to knee braces.
Patients and Methods
We prospectively enrolled 91 patients with symptomatic medial compartmental knee OA and randomized to treatment with either a 10-mm laterally wedged insole (index group, n = 45) or a valgus brace (control group, n = 46). All patients were assessed at 6 months. The primary outcome measure was pain severity as measured on a visual analog scale. Secondary outcome measures were knee function score using WOMAC and correction of varus alignment on AP whole-leg radiographs taken with the patient in the standing position. Additionally, we compared the percentage of responders according to the OMERACT-OARSI criteria for both groups.
We observed no differences in pain or WOMAC scores between the two groups. Neither device achieved correction of knee varus malalignment in the frontal plane. According to the OMERACT-OARSI criteria, 17% of our patients responded to the allocated intervention. Patients in the insole group complied better with their intervention. Although subgroup analysis results should be translated into practice cautiously, we observed a slightly higher percentage of responders for the insole compared with bracing for patients with mild medial OA.
Our data suggest a laterally wedged insole may be an alternative to valgus bracing for noninvasively treating symptoms of medial knee OA.
Level of Evidence
Level I, therapeutic study. See the Guidelines for Authors for a complete description of level of evidence.
- Baker K, Goggins J, Xie H, Szumowski K, LaValley M, Hunter DJ, Felson DT. A randomized crossover trial of a wedged insole for treatment of knee osteoarthritis. Arthritis Rheum. 2007;56:1198–1203.
- Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15:1833–1840.
- Brookes ST, Whitely E, Egger M, Smith GD, Mulheran PA, Peters TJ. Subgroup analyses in randomized trials: risks of subgroup-specific analyses; power and sample size for the interaction test. J Clin Epidemiol. 2004;57:229–236.
- Brouwer GM, van Tol AW, Bergink AP, Belo JN, Bernsen RM, Reijman M, Pols HA, Bierma-Zeinstra SM. Association between valgus and varus alignment and the development and progression of radiographic osteoarthritis of the knee. Arthritis Rheum. 2007;56:1204–1211.
- Brouwer RW, Bierma-Zeinstra SM, van Raaij TM, Verhaar JA. Osteotomy for medial compartment arthritis of the knee using a closing wedge or an opening wedge controlled by a Puddu plate: a one-year randomised, controlled study. J Bone Joint Surg Br. 2006;88:1454–1459.
- Brouwer RW, Jakma TS, Bierma-Zeinstra SM, Ginai AZ, Verhaar JA. The whole leg radiograph: standing versus supine for determining axial alignment. Acta Orthop Scand. 2003;74:565–568.
- Brouwer RW, Jakma TS, Verhagen AP, Verhaar JA, Bierma-Zeinstra SM. Braces and orthoses for treating osteoarthritis of the knee. Cochrane Database Syst Rev. 2005;1:CD004020.
- Brouwer RW, van Raaij TM, Verhaar JA, Coene LN, Bierma-Zienstra SM. Brace treatment for osteoarthritis of the knee: a prospective randomized multi-centre trial. Osteoarthritis Cartilage. 2006;14:777–783.
- Cooke TD, Harrison L, Khan B, Scudamore A, Chaudhary MA. Analysis of limb alignment in the pathogenesis of osteoarthritis: a comparison of Saudi Arabian and Canadian cases. Rheumatol Int. 2002;22:160–164.
- Draganich L, Reider B, Rimington T, Piotrowski G, Mallik K, Nasson S. The effectiveness of self-adjustable custom and off-the-shelf bracing in the treatment of varus gonarthrosis. J Bone Joint Surg Am. 2006;88:2645–2652.
- Felson DT, Zhang Y. An update on the epidemiology of knee and hip osteoarthritis with a view to prevention. Arthritis Rheum. 1998;41:1343–1355.
- Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957;16:494–502.
- Kemp G, Crossley KM, Wrigley TV, Metcalf BR, Hinman RS. Reducing joint loading in medial knee osteoarthritis: shoes and canes. Arthritis Rheum. 2008;59:609–614.
- Kerrigan DC, Lelas JL, Goggins J, Merriman GJ, Kaplan RJ, Felson DT. Effectiveness of a lateral-wedge insole on knee varus torque in patients with knee osteoarthritis. Arch Phys Med Rehabil. 2002;83:889–893.
- Kirkley A, Webster-Bogaert S, Litchfield R, Amendola A, MacDonald S, McCalden R, Fowler P. The effect of bracing on varus gonarthrosis. J Bone Joint Surg Am. 1999;81:539–548.
- Krohn K. Footwear alterations and bracing as treatments for knee osteoarthritis. Curr Opin Rheumatol. 2005;17:653–656.
- Ogata K, Yasunaga M, Nomiyama H. The effect of wedged insoles on the thrust of osteoarthritic knees. Int Orthop. 1997;21:308–312.
- Pham T, Maillefert JF, Hudry C, Kieffert P, Bourgeois P, Lechevalier D, Dougados M. Laterally elevated wedged insoles in the treatment of medial knee osteoarthritis: a two-year prospective randomized controlled study. Osteoarthritis Cartilage. 2004;12:46–55.
- Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004;12:389–399.
- Ramsey DK, Briem K, Axe MJ, Snyder-Mackler L. A mechanical theory for the effectiveness of bracing for medial compartment osteoarthritis of the knee. J Bone Joint Surg Am. 2007;89:2398–2407.
- Richards JD, Sanchez-Ballester J, Jones RK, Darke N, Livingstone BN. A comparison of knee braces during walking for the treatment of osteoarthritis of the medial compartment of the knee. J Bone Joint Surg Br. 2005;87:937–939.
- Rothman KJ, Greenland S, Lash TL. Modern Epidemiology. Ed 3. Philadelphia, PA: Lippincott Williams & Wilkins; 2008.
- Sharma L, Song J, Felson DT, Cahue S, Shamiyeh E, Dunlop DD. The role of knee alignment in disease progression and functional decline in knee osteoarthritis. JAMA. 2001;286:188–195.
- Shelburne KB, Torry MR, Steadman JR, Pandy MG. Effects of foot orthoses and valgus bracing on the knee adduction moment and medial joint load during gait. Clin Biomech (Bristol, Avon). 2008;23:814–821.
- Toda Y, Segal N. Usefulness of an insole with subtalar strapping for analgesia in patients with medial compartment osteoarthritis of the knee. Arthritis Rheum. 2002;47:468–473.
- Toda Y, Tsukimura N. A 2-year follow-up of a study to compare the efficacy of lateral wedged insoles with subtalar strapping and in-shoe lateral wedged insoles in patients with varus deformity osteoarthritis of the knee. Osteoarthritis Cartilage. 2006;14:231–237.
- van Raaij TM, Reijman M, Brouwer RW, Jakma TS, Verhaar JN. Survival of closing-wedge high tibial osteotomy: good outcome in men with low-grade osteoarthritis after 10–16 years. Acta Orthop. 2008;79:230–234.
- Medial Knee Osteoarthritis Treated by Insoles or Braces: A Randomized Trial
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Clinical Orthopaedics and Related Research®
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- 1. Department of Orthopaedics, HS-105, Erasmus University Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands
- 2. Department of Orthopaedics, Martini Hospital, Groningen, The Netherlands
- 3. Department of General Practice, Erasmus University Medical Center, Rotterdam, The Netherlands