Prospective Pilot Study of Robotic-Assisted Harvest of the Latissimus Dorsi Muscle: A 510(k) Approval Study with U.S. Food and Drug Administration Investigational Device Exemption

摘要

Background: There are no U.S. Food and Drug Administration (FDA)–approved indications for robotic plastic surgery. This study was designed to demonstrate safety and efficacy of the robotic latissimus dorsi harvest for FDA approval. Methods: This prospective, single-arm study was conducted under an investigational device exemption through the FDA for obtaining 510(k) approval. The primary safety endpoint was adverse events attributable to harvest. Primary efficacy endpoints included muscle viability after harvest and conversion to open technique. Secondary endpoints included postoperative pain and upper extremity function. Results: Fifteen patients enrolled, with a mean age of 50 ± 10 years and a mean body mass index of 25 ± 4 kg/m 2 . There were no adverse events, all muscles were viable after harvest, and there were zero conversions to open procedures. Visual analogue scale scores for pain progressively decreased postoperatively and returned to baseline, indicating resolution of postoperative pain. Physical therapy assessment demonstrated recovery of function in all range-of-movement domains by 36 weeks. There was no difference in function of the operated extremity between baseline and 36 weeks’ follow-up for Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire ( p = 0.87); QuickDASH Work Module ( p > 0.05); and QuickDASH Sports Module ( p > 0.05). Conclusions: The use of the da Vinci Robotic Surgical System is safe based on zero adverse events attributable to harvest and efficacious based on 100 percent muscle viability after harvest and zero conversions to open technique. There appears to be little to no long-term functional deficit or pain from muscle harvest. Given these results and their own prestudy guidelines, the robotic latissimus dorsi qualifies for 510(k) submission by Intuitive Surgical and approval by the U.S. FDA. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.