Study on Personalized Total Knee Arthroplasty (TKA) Rehabilitation Using Telemedicine and Psychoeducation

To ensure quality and ethical standards in the design and implementation of our randomized clinical trial (RCT), we will apply the Helsinki criteria and the CONSORT checklist. All patients hospitalized for rehabilitation after total knee arthroplasty (TKA) at the San Giovanni di Dio Rehabilitation Center in Adelfia (BA) will be evaluated for eligibility to participate in a clinical study on primary symptomatic osteoarthritis (OA) of the knee between July and October 2025.Inclusion criteria (in addition to those already mentioned in the brief summary): •Ability to stand on one leg. Exclusion criteria: •Post-traumatic or inflammatory knee OA; •Valgus/varus deformity (hip-knee-ankle angle > or < 10°).The control group and the study group, after medical, physiotherapeutic, and psychological assessment, will receive a treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and gait training. This will be delivered in two physiotherapy sessions per day, each lasting 45 minutes, during the 22-25 days of hospitalization. Following discharge, participants will receive outpatient treatment consisting of two 45-minute sessions per week for three months at a physiotherapy clinic. The control group will follow this program as usual, while the study group will have the same program reinforced with home supervision via telemedicine. A physiotherapist, trained on the initial psychological assessments, will conduct teleconsultations using Zoom (with end-to-end encryption). Patient characteristics and outcome measures will be reported in aggregate form, as mean ± standard deviation for continuous variables and absolute frequencies (percentages) for categorical variables. Statistical analysis of outcomes will include testing the significance of differences. The two groups will be compared based on baseline characteristics and changes in outcomes. Data Profile: Since variables are non-normally distributed (Shapiro-Wilk test), the study uses non-parametric methods. Data is expressed as medians (IQR) or frequencies (%).

Baseline Comparisons: Groups are compared via the Mann-Whitney U test (continuous) and χ 2 or Fisher's exact tests (categorical). Longitudinal Analysis: Clinical outcomes over time (T0-T2) are evaluated using a non-parametric mixed-effects model to analyze time, group, and their interaction. Changes & Correlations: Relative variation is calculated as Δ=(T 2-T0)/T0. Its relationship with baseline psychological scores is assessed via Spearman's correlation. Thresholds: Analyses are performed in R (v4.2), using a significance threshold of p<0.05.

Inclusion criteria

• Recent unilateral total knee arthroplasty;
• Body Mass Index (BMI) < 35;
• Ability to stand on one leg;
• Absence of active known neurological or oncological diseases.

Exclusion criteria

• Post-traumatic or inflammatory knee osteoarthritis (OA);
• Valgus/varus deformity (hip-knee-ankle angle > or < 10°).