The effect of bracing on varus gonarthrosis. Laterally elevated wedged insoles in the treatment of medial knee osteoarthritis: a prospective randomized controlled study. Effect of a novel insole on the subtalar joint of patients with medial compartment osteoarthritis of the knee. Usefulness of an insole with subtalar strapping for analgesia in patients with medial compartment osteoarthritis of the knee. Brace treatment for osteoarthritis of the knee: a prospective randomized multi-centre trial.
The purpose of this study was to compare a custom-made valgus-producing functional knee (unloader) brace, a neoprene sleeve, and medical treatment only (control group) with regard to their ability to improve the disease-specific quality of life and the functional status of patients who had osteoarthritis in association with a varus deformity of the knee (varus gonarthrosis).
                The study design was a prospective, parallel-group, randomized clinical trial. Patients who had varus gonarthrosis were screened for eligibility. The criteria for exclusion included arthritides other than osteoarthritis; an operation on the knee within the previous six months; symptomatic disease of the hip, ankle, or foot; a previous fracture of the tibia or femur; morbid obesity (a body-mass index of more than thirty-five kilograms per square meter); skin disease; peripheral vascular disease or varicose veins that would preclude use of a brace; a severe cardiovascular deficit; blindness; poor English-language skills; and an inability to apply a brace because 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 with use of sealed envelopes. The patients were stratified according 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 degrees of varus), and the status of the anterior cruciate ligament (torn or intact). The patients were randomly assigned to one of three treatment groups: medical treatment only (control group), medical treatment and use of a neoprene sleeve, or medical treatment and use of an unloader brace. The disease-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 function was assessed with use of the six-minute walking and thirty-second stair-climbing tests. The primary outcome measure consisted of an analysis of covariance of the change in scores between the baseline and six-month evaluations.
                One hundred and nineteen patients were randomized. The control group consisted of forty patients (thirty-one men and nine women; mean age, 60.9 years); the neoprene-sleeve group, of thirty-eight patients (twenty-seven 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 quality of life (p = 0.001) and in function (p< or =0.001) in 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 with regard to pain after both the six-minute walking test (p = 0.021) and the thirty-second stair-climbing test (p = 0.016). There was a strong trend toward a significant difference between 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 scores (p = 0.081).
                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 options remain to be identified. To compare the clinical effects of laterally wedged insoles and neutrally wedged insoles (used as control) in patients with medial femoro-tibial knee osteoarthritis (OA).
                6-month prospective randomized controlled study.
                outpatients with painful medial femoro-tibial knee OA.
                patient's overall assessment of disease activity (5 grade scale), WOMAC index subscales and concomitant treatments.
                Performed as an intention-to-treat analysis. Main criterion: improvement in the patient's assessment of activity (defined as a reduction of 1 grade or more at month 6 compared to baseline, and no intraarticular injection or lavage during the study). Secondary criteria for assessment: (a) improvement in the patient's assessment of activity at months 1 and 3 compared to baseline, (b) improvement in the WOMAC subscales at months 1, 3 and 6, compared to baseline (defined as an improvement of at least 30%, and no intraarticular injection or lavage during the study) and (c) concomitant therapies (analgesics and NSAIDs).
                The baseline characteristics of the 156 recruited patients (41 males, 115 females, mean age 64.8 years) were not different in the two treatment groups. At months 1, 3 and 6 the percentages of patients with improvement in assessment of disease activity, in WOMAC pain, joint stiffness, and physical functioning subscales were similar in the two groups. The number of days with NSAIDs intake during the previous 3 months was decreased at month 6 compared with baseline in the group furnished with laterally wedged insoles (14.1 days+/-28 vs 9.9 days+/-27, P=0.04, Wilcoxon paired test), while it remained unchanged in the other group (15.5 days+/-24 vs 15+/-28, P=0.56). Compliance and tolerance were satisfactory. Compliance was different between the two groups at month 6, with a greater frequency of patients who wore insoles permanently in the laterally wedged insole group than in the other group (87.8% vs 74.3%;P=0.032).
                This study failed to demonstrate a relevant short-term symptomatic effect of laterally-wedged insoles in medial femoro-tibial OA. However, the decrease in NSAIDs consumption together with better compliance in the treated group are in favor of a beneficial effect of laterally-wedged insoles in medial femoro-tibial OA.
                Copyright 2001 OsteoArthritis Research Society International. To assess the efficacy of a lateral wedge insole with elastic strapping of the subtalar joint for conservative treatment of osteoarthritis (OA) of the knee.
                The efficacy of a novel insole with elastic subtalar strapping and a traditional shoe insert wedge insole was compared. Ninety female outpatients with OA of the knee were treated with wedge insoles for 8 weeks. Randomization was performed according to birth date. Standing radiographs with unilateral insole use were used to analyze the femorotibial and talar tilt angles for each patient with and without their respective insole. Visual analog scale (VAS) score for subjective knee pain at the final assessment was compared with that at baseline in both groups.
                Participants wearing the elastically strapped insole (n = 46) had significantly decreased femorotibial angle (p < 0.0001) and talar tilt angle (p = 0.005) and significantly improved VAS pain score (p = 0.045) in comparison with baseline assessments. These significant differences were not found in the group with the inserted insole (n = 44).
                The novel strapped insole leads to valgus angulation of the talus, resulting in correction of the femorotibial angle in patients with knee OA with varus deformity, and may have a therapeutic effect similar to that of high tibial osteotomy. To assess the effect of an insole with subtalar strapping on patients with medial compartment osteoarthritis (OA) of the knee.
                Novel lateral wedged insoles with elastic subtalar strapping (the subtalar strapping support group) and ankle supporters with a lateral wedged heel insert (the sock-type ankle support group) were prepared. Eighty-eight female outpatients with knee OA were treated with 1 of the 2 insoles for 8 weeks. Femorotibial angle was assessed by standing radiographs with and without unilateral insole use for each subject. Symptoms of knee OA were evaluated according to the severity index of Lequesne et al at baseline and at the final assessment.
                Participants wearing the insole with subtalar strapping (n = 42) demonstrated significantly decreased femorotibial angle (an average of change: -3.1 degrees +/- 2.5 degrees, P < 0.0001), but a significant difference was not found in the sock-type ankle support group (n = 46; -0.4 degrees +/- 1.1 degrees, P > 0.05). In the subtalar strapping support group, pain during bed rest with full extension of the knee (P < 0.0001), pain after getting up (P = 0.04), pain on getting up from a seated position (P = 0.021), maximum distance walked (P = 0.009), and aggregate severity score (P < 0.0001) were significantly improved compared with baseline. In contrast, significant symptomatic improvement was detected only in the aggregate score (P = 0.016) in the sock-type ankle support group, but not in any of the 10 specific categories.
                The lateral wedged insole with subtalar strapping induces correction of the femorotibial angle and symptomatic relief in patients with varus-deformity knee OA. To evaluate the effect of a brace intended to reduce load in patients with medial or lateral compartmental osteoarthritis (OA) and concurrent varus or valgus alignment, respectively.
                This multi-centre randomized controlled trial (performed 2001-2003) studies the additive effect of a brace intended to reduce load in conservative treatment of unicompartmental OA of the knee. Setting: Orthopedic department of a university medical centre and of one general hospital. The follow-up was 12 months. Patients: 117 patients with unicompartmental OA of the knee. Intervention group (n=60) comprising conservative treatment with additional brace treatment and a control group (n=57) comprising conservative treatment alone. Primary outcome measures: Pain severity and knee function score. Secondary outcome measures: Walking distance and quality of life. Analysis: Multiple linear regression models according to the intention-to-treat-principle were used to assess outcome differences for the entire group of patients. In addition, we performed explorative subgroup analyses on primary overall outcomes stratified for alignment, degree of OA, origin of OA, and age.
                Although the primary outcome measures were improved in the intervention group in comparison with the controls at each assessment point, the differences reached only borderline significance. The reported walking distances at 3 months, 12 months and overall were significantly longer in the brace group (P=0.03, P=0.04 and P=0.02, respectively). Subgroup analysis showed a better effect in the varus group, in patients with severe OA, in patients with secondary OA and in patients younger then 60 years. In total 25 patients in the brace group and 14 in the control group changed their initial treatment, mostly (74%) because of a lack of beneficial effect.
                The results indicate that a brace intended to reduce load shows small effects in patients with unicompartmental OA. However, many patients do not adhere in the long run to this kind of conservative treatment.