Chronic effects of a flexible and minimalist footwear on clinical, functional and gait biomechanical aspects in the knee osteoarthritis: a single-blind randomized clinical trial

s / Osteoarthritis and Cartilage 20 (2012) S54–S296 S176 Conclusions: This open-label study shows that i.a. HA injection for TMCJ OA leads to a significant improvement in all the investigated parameters, which is still present after six months from baseline. There are currently two broad categories proposed for the mechanism of action by which HA may elicit short-and long-term pain relief: rheological or biomechanical and biological (anti-inflammatory, anabolic, analgesic, chondroprotective and anticatabolic) effects through interactions between HA and its receptors CD44, RHAMM, ICAM-1. It is possible that one of the functions of CD44 in stem cells may be to facilitate the endocytosis of HA which then may act as a protector of their DNA from oxidants. Our study confirms that i.a. injections of HA in TMCJ are easily administered, and may give symptomatic benefit with minimal side effects. 347 CHRONIC EFFECTS OF A FLEXIBLE AND MINIMALIST FOOTWEAR ON CLINICAL, FUNCTIONAL AND GAIT BIOMECHANICAL ASPECTS IN THE KNEE OSTEOARTHRITIS: A SINGLE-BLIND RANDOMIZED CLINICAL TRIAL F. Trombini-Souza, A. Matias, M. Yokota, C. Schainberg, R. Fuller, I.C. Sacco. Univ. of Sao Paulo, Sao Paulo, Brazil Purpose: Recent studies have shown that the acute use of shoes that mimic barefoot gait decrease substantially knee loads while walking in elderly with knee osteoarthritis (OA). Probably due to methodological difficulties to implement this type of conservative treatment during extended period, the effectiveness of minimalist footwear has not been evaluated yet in elderly patients with knee OA. The purpose is to describe a randomized clinical trial protocol for evaluating the therapeutic effect of a minimalist (flexible, non-heeled) and inexpensive footwear on clinical, functional, and biomechanical gait in elderly women with knee OA. Methods: Fifty six elderly womenwith knee OA grade 2 or 3 (Kellgren and Lawrence) will be randomized in blocks and allocated in the intervention group thatwill use aflexiblenon-heeled shoes -Moleca for at least 6hours daily or in the control group, which could not use these shoes or be under physical therapy or acupuncture treatment throughout these sis months. The use of Paracetamol 500mg every six hour was allowed for both groups in case of pain.Moleca (CalcadosBeiraRio S.A., NovoHamburgo, RS, Brazil) is a women's double canvas flexible flat walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm internal wedge of ethylene vinyl acetate. The mean weight is 172 19.6 g, ranging from 142 to 193 g depending on the size. Both groups will be followed during 6months. They will be assessed at baseline condition, after 3 months (intervention group) and after 6months of baseline condition (end of intervention, both groups). All the assessments will be performed by a physiotherapist that is blind to which group the patientwas allocated. Themain outcome assessment is the pain WOMAC score and the secondary outcomes are other WOMAC scores pain assessment (visual analogue scale VAS), Lequesne index, Six-Minute Walk Test, and biomechanical gait analysis by means of 6 infrared cameras and a multi-component force plate to determine the knee adduction moment during gait. At baseline, all patients receive a diary to record the hours of daily use of footwear intervention. Every two weeks, the same physiotherapist carries phone calls to all patients in order to verify adherence to treatment and the correctfilling this diary. The intergroupand intermoments will be performed by repeated measures analysis of variance (a1⁄40.05). This Trial was approved by the local Ethics Committee and was registered in ClinicalTrials.gov Identifier: NCT01342458. Results: Six hundred thirty-four elderly women have been contacted so far and 20 have already been allocated in the intervention group (9) and in the control (11). Five patients from intervention group have already completed all 3 assessments and finished the protocol. The preliminary results have shown that the elderly women of the intervention group have used the Moleca shoe for an average monthly of 7 hours and 24 minutes ( 3:47), corresponding to approximately 50% of the home-work hours of the day. Conclusion: This is the first randomized clinical trial protocol to assess the chronic effect of a minimalist footwear on the clinical, functional and gait biomechanics of elderly women with knee osteoarthritis. We expect that the use of Moleca shoes for 6 months provides pain relief, reduction of the knee adduction moment while walking and improves joint function in elderly women with knee OA, and therefore can be considered as another inexpensive option for conservative OA treatment. The authors are pleased to acknowledge the financial support of State of Sao Paulo Research Foundation FAPESP (processes: 2011/01640-8, 2011/ 03300-0, 2011/03069-6). 348 RANDOMIZED, DOUBLE-BLIND CONTROL TRIAL OF PERI-ARTICULAR HYALURONIC ACID:BOTULINUS TOXIN INJECTION IN LATERAL EPICONDYLOSIS. R.J. Petrella , J. Decaria , M. Petrella . U Western Ontario, London, ON, Canada; 2 Lawson Hlth.Res. Inst., London, ON, Canada Purpose: To compare and describe the effects of peri-articular hyaluronic acid (HA) coadminsitered with botulinus toxin (Botox) versus placebo in lateral epicondylosis. Methods: 28 patients with elbow pain longer than two weeks and less than 12 months, particularly exacerbated during resisted dorsiflexion of thewrist with the elbow in full extensionwith a VAS score> 4.5 cm on a 010 cm VAS were included. Assessments were done at baseline, days 7, 14, 30 and 90. Efficacymeasures included patient's visual analogue scale (VAS) of pain at rest (0-100 mm) and following assessment of grip strength (0100 mm). Grip strength was determined using a jamar hydraulic hand dynamometer. Other assessments included patients’ global assessment of elbow injury (5 point categorical scale; 1 1⁄4 no disability, 5 1⁄4 maximal disability), patients’ assessment of normal function/activity (5 point categorical scale), patients/physician satisfaction assessment (10 point categorical scale), and adverse events as per WHO definition. Differences between groups were determined using an intent-to-treat ANOVA. After outcome assessment, patients were randomized to treatment with a single injection of: HA + Botox (0.7 cc HA + 40 units Botox), HA alone (0.7 cc), Botox (40 units), placebo (normal saline 0.7 cc). Injections were done freehand into the origin of the extensor carpi radialis brevis (ECRB). Results: All patients completed the trial. Adverse events included pain and swelling in one patient in the HA group at day 7 and ECRB weakness for 48 hours in one patient in the Botox group following injection. At 7 days, a significant improvement (p<0.05) from baseline and versus placebo in VAS pain at rest and following grip testing was observed in all three treatment groups. Grip strength was greater (p<0.05) for HA+Botox vs other groups at 14, 30 and 90 days. Further, HA +Botox showed small but significant patient perception of normal function versus HA or Botox at one month (p<0.05). However, at 90 days, HA+ Botox showed significantly (p<0.03) greater physician satisfaction versus all other groups. There were no differences in patient global satisfaction between treatment groups at 7 or 90 days, but HA + Botox showed greater satisfaction at 14 and 30 days. Conclusion: Peri-articular HA + Botox produced superior clinical and statistical improvement in shortand long-term pain and function compared to placebo and Ha or Botox alone with serious adverse effects. Epidemiology & Health Services Research 349 HORMONE REPLACEMENT THERAPY PREVENTS FAILURE AFTER TOTAL KNEE (TKA) AND HIP (THA) ARTHROPLASTY: A POPULATION-BASED RETROSPECTIVE COHORT STUDY. D. Prieto-Alhambra , M. Javaid , A. Judge , J. Maskell , C. Cooper , N.K. Arden . Botnar Res. Ctr., Univ. of Oxford, Oxford, United Kingdom; 2 Inst. Catala de la Salut-IDIAP Jordi Gol, Barcelona, Spain; MRC Lifecourse Epidemiology; Southampton Univ., Southampton, United Kingdom Purpose: Rates of primary total knee (TKA) and hip (THA) arthroplasties are increasing worldwide. Together with patient reported outcomes, implant survival is an important element in the evaluation of joint replacement surgery. There is an urgent need to identify potential interventions to improve implant outcomes. Hormone replacement therapy (HRT) might minimise osteolysis and loosening through its anti-resorptive effects, and hence improve prosthesis survival.