The effect of bracing on varus gonarthrosis

Background The purpose of this study was to compare a custom-made valgus-pr oducing functional knee (unloader) brace, a neoprene sleeve, and medical tr eatment only (control group) with regard to their ability to improve the di sease-specific quality of life and the functional status of patients who ha d osteoarthritis in association with a varus deformity of the knee (varus g onarthrosis), Methods: The study design was a prospective, parallel-group, randomized cli nical trial. Patients who had varus gonarthrosis were screened for eligibil ity. The criteria for exclusion included arthritides other than osteoarthri tis; an operation on the knee within the previous six months; symptomatic d isease of the hip, ankle, or foot; a previous fracture of the tibia or femu r; morbid obesity (a body-mass index of more than thirty-five kilograms per square meter); skin dis; ease; peripheral vascular disease or varicose vei ns that would preclude use of a brace; a severe cardiovascular deficit; bli ndness; poor English-language skills; and an inability to apply a brace bec ause of physical limitations such as arthritis in the hand or an inability to bend over. Treatment was assigned on the basis of a computer-generated block method of randomization,vith use of sealed envelopes. The patients were stratified a ccording to age (less than fifty years or at least fifty years), deformity (the mechanical axis in less than 5 degrees of varus or in at least 5 degre es of varus), and the status of the anterior cruciate ligament (torn or int act). The patients were randomly assigned to one of three treatment groups: medical treatment only (control group), medical treatment and use of a neo prene sleeve, or medical treatment and use of an unloader brace, The diseas e-specific quality of life was measured with use of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and the McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (MACTAR), and functio n was assessed,vith use of the six-minute walking and thirty-second stair-c limbing tests. The primary outcome measure consisted of an analysis of cova riance of the change in scores between the baseline and six-month evaluatio ns. Results: One hundred and nineteen patients were randomized. The control gro up consisted of forty patients (thirty-one men and nine women; mean age, 60 .9 years); the neoprene-sleeve group, of thirty-eight patients (twenty-seve n men and eleven women; mean age, 58.2 years); and the unloader-brace group , of forty-one patients (twenty-eight men and thirteen women; mean age, 59. 5 years). Nine patients withdrew from the study. At the six-month follow-up evaluation, there was a significant improvement in the disease-specific qu ality of life (p = 0.001) and in function (p less than or equal to 0.001) i n both the neoprene-sleeve group and the unloader-brace group compared with the control group. There was a significant difference between the unloader -brace group and the neoprene-sleeve group,vith regard to pain after both t he six-minute walking test (p 0.021) and the thirty-second stair-climbing t est (p 0.016), There was a strong trend toward a significant difference bet ween the unloader-brace group and the neoprene-sleeve group with regard to the change in the WOMAC aggregate (p = 0.062) and WOMAC physical function s cores (p = 0.081), Conclusions: The results indicate that patients who have varus gonarthrosis may benefit significantly from use of a knee brace in addition to standard medical treatment. The unloader brace was, on the average, more effective than the neoprene sleeve. The ideal candidates for each of these bracing op tions remain to be identified.