Effect of biomechanical correction of tibia on medial joint space loading, varus deformity and functional tasks in patients with medial tibiofemoral joint osteoarthritis: a two-group pre-test, post-test randomized clinical trial study protocol

Abstract

BACKGROUND/OBJECTIVES: Knee osteoarthritis (KOA) is the most prevalent chronic disease of joints. There are various biomechanical factors which affect the alignment of the knee joints resulting in the varus or valgus deformities, which leads to unequal loading on the joints structures. The primary aim of the study is to determine the biomechanical corrections on tibia and varus deformity in Medial Tibiofemoral Knee Joint Osteoarthritis (MTKJOA). Secondary aim is to see the improvement in physical functions of the patients. METHODOLOGY/DESIGN: A Two Group Pretest-Posttest Equivalent Randomized Clinical Trial. Total ‘52’ patients will be included between the age of 35 to 80 years with medial tibiofemoral joint osteoarthritis. Subjects will be divided in the biomechanical correction group (Mobilization with movement in addition with conventional physiotherapy treatment). Conventional physiotherapy group which include electrotherapy and exercise therapy. For measuring the pain, the Numeric Pain Rating Scale (NPRS) will be taken, for range of motion goniometer will be taken, Western Ontario McMaster Universities Arthritis Index (WOMAC) will be taken for assessing the physical performance and TraumaCaD Software will be used to determine the alignment of the affected limb. In both the groups, conventional physiotherapy treatment will be given for 9 days. Total 9 sessions will be in given in three weeks and in each week 3 sessions will be given on alternative days. The outcome will be measured at baseline. TRIAL REGISTRATION: Clinical Trials Registry – India. (NCT04324931). UNIVERSAL TRIAL NUMBER: U1111-1249-3661. DISCUSSION: To our knowledge this study will be the first to correct the biomechanical axis of knee joints. After Biomechanical Correction, the weight bearing distribution will be adjusted and progression of deformity can be reduced which will help to improve the functional tasks and prevent to undergo early Total Knee Arthroplasty (TKA).