A pilot trial of tongue reconstruction using the chimeric innervated vastus lateralis muscle and antero-lateral thigh free flap

Background: Subtotal and total glossectomies for advanced tongue cancer result in significant speech- and swallow-related morbidity, impairing quality of life. This prospective pilot study compares the safety and functional outcomes associated with using a chimeric innervated muscle and fasciocutaneous flap for soft tissue reconstruction. Materials and Methods: A prospective, non-randomized controlled pilot study evaluated a standardized technique for tongue reconstruction using a chimeric innervated vastus lateralis muscle and anterolateral thigh fasciocutaneous flap. Inclusion criteria were ≥ 50% resection of the oral tongue. Participants were followed longitudinally, with measures recorded at baseline, 6–8 weeks, 6 months, and 12 months after surgery. The primary endpoints were post-operative complications, time to radiotherapy, operative time, and locoregional failure, videofluoroscopy swallow studies (dynamic imaging grade of swallowing toxicity (DIGEST), penetration and aspiration score, performance status scale for head and neck). Secondary endpoints were patient-rated outcomes. Results: Eighteen participants were recruited (10 intervention: 8 controls). Fourteen (78%) experienced complications, only one of which was related to the innervated flap. DIGEST scores deteriorated post-operatively across all participants but did not differ significantly between the intervention and control groups (p = 0.4) at any point post-surgery, despite more extensive resections in the intervention group. Those in the intervention group had better patient-rated intelligibility (p = 0.04). Multimodality treatment was associated with worse speech (p = 0.03) and normalcy of diet (p = 0.02). Less extensive resections were associated with better scores in eating in public (p = 0.005), tongue range of movement (p = 0.0008), intelligibility (p = 0.006), and diet (p = 0.001). Conclusions: The innervated vastus lateralis and antero-lateral thigh free-flap technique is safe and improves speech intelligibility for patients with subtotal and total glossectomy defects. However, the technique requires refinement to optimize functional and quality-of-life outcomes.