A shallow sulcus characterizes trochlear dysplasia (TD) of the femoral trochlea, which can lead to chronic pain or instability of the patellofemoral joint. Breech presentation at birth has been identified as a risk factor for developing this condition, which an ultrasound can identify early. Early treatment could be considered at this stage, given the potential for remodelling in these skeletally immature patients. Newborns with breech presentation at birth who meet the inclusion criteria will be enrolled and randomised in equal proportions between treatment with the Pavlik harness and observation. The primary objective is to determine the difference in the means of the sulcus angle between the two treatment arms at two months. Ours is the first study protocol to evaluate an early non-invasive treatment for TD in the newborn with breech presentation at birth using a Pavlik harness. We hypothesised that trochlear dysplasia could be reverted when identified and treated early in life with a simple harness, as it is done with developmental dysplasia of the hip.
Background: This pilot study assessed whether a modified Pavlik harness (mPH) could safely and feasibly influence trochlear morphology in newborns with developmental trochlear dysplasia (DTD). Methods: Seven consecutive newborns (14 knees) with breech presentation and ultrasound-confirmed DTD (sulcus angle ≥150 degrees) were prospectively enrolled in this proof-of-concept study. Bilateral knee ultrasound measured sulcus angle before and after 8-week continuous mPH treatment. Pre- and post-treatment measurements were compared using paired t tests, with P <0.05 considered significant. Results: Both knees demonstrated a statistically significant reduction in sulcus angle. Mean sulcus angle decreased from 152.36±2.39 to 146.43±2.20 degrees (MD: 5.93 degrees, P =0.001) when combining bilateral measurements. Six of 7 newborns with DTD (85.70%) showed improvements ≥4 degrees. All newborns demonstrated high compliance with mPH, with no complications or adverse events reported. Conclusion: This preliminary study clearly demonstrates that early mPH treatment can safely influence trochlear morphology in newborns with DTD. These encouraging anatomic changes establish a strong foundation; however, this proof-of-concept study must be validated in larger, controlled trials with long-term follow-up to determine the clinical significance and facilitate its potential integration into screening protocols. Level of Evidence: Level IV—therapeutic case series.