This study aimed to define whether distal vastus medialis (VM) muscle strengthening improves functional outcomes compared to general quadriceps muscle strengthening after first-time patellar dislocation (FTPD). Fifty patients post-FTPD were randomised to either a general quadriceps exercise or rehabilitation programme (n=25) or a specific-VM exercise and rehabilitation regime (n=25). The primary outcome was the Lysholm knee score, and secondary outcomes included the Tegner Level of Activity score, the Norwich Patellar Instability (NPI) score, and isometric knee extension strength at various knee flexion ranges of motion. Outcomes were assessed at baseline, six weeks, six months and 12 months. There were statistically significant differences in functional outcome and activity levels with the Lysholm knee score and Tegner Level of Activity score at 12 months in the general quadriceps exercise group compared to the VM group (p=0.05; 95% confidence interval (CI): -14.0 to 0.0/p=0.04; 95% CI: -3.0 to 0.0). This did not constitute a clinically important difference. There was no statistically significant difference between the groups for the NPI score and isometric strength at any follow-up interval. The trial experienced substantial participant attrition (52% at 12months).
Although there was a statistical difference in the Lysholm knee score and Tegner Level of Activity score between general quadriceps and VM exercise groups at 12 months, this might not necessarily have been of clinical significance. This trial highlights that participant recruitment and retention are challenges which should be considered when designing future trials in this population.