Observational Outcomes: Wharton’s Jelly Tissue Allografts in Tarsal Tunnel Syndrome
Tarsal tunnel syndrome involves compression of the tibial nerve, often associated with defects or degeneration of the surrounding connective tissues. This IRB-reviewed study evaluated the safety profile and patient-reported outcomes of cryopreserved Umbilical Cord Tissue (UCT) allografts applied to supplement connective tissue defects in the tarsal tunnel region among patients who had not experienced adequate improvement with standard conservative care.
UCT allografts are Section 361 HCT/Ps intended for the homologous supplementation of damaged or missing connective tissue. They are not drugs or biologics and do not claim to treat or cure any condition.
Study Overview
Eight patients across four clinical sites received a single ultrasound-guided UCT allograft application after failing at least six weeks of conservative management. Patient-reported outcomes were assessed over 90 days using the Numeric Pain Rating Scale (NPRS) and the WOMAC functional index. All procedures adhered to applicable FDA and AATB guidelines.
Results
No adverse events were reported across the study cohort. From baseline to Day 90, patients reported an average 59.43% improvement in NPRS pain scores and a 37.58% improvement in WOMAC functional scores. As with all observational data, these findings should be interpreted in the context of study design limitations and do not establish causation or generalizability.
Clinical Significance
These preliminary findings support continued investigation into the homologous use of UCT allografts as a minimally invasive option for patients with connective-tissue–related symptoms in the tarsal tunnel region who have not responded to conservative care. Clinicians are encouraged to evaluate this data alongside the broader evidence base and in the context of individual patient presentation and clinical judgment.