Treace Medical Concepts said a study of its bunion implant surgery showed a high healing rate in patients undergoing an accelerated recovery protocol.
The study of the Ponte Vedra, Fla.-based company’s Lapiplasty 3D bunion correction system showed that most patients were able to stand on their operative foot five days after surgery and had a high rate of healing nine months after the procedure.
The study enrolled 195 patients, including 19.5% who had comorbidities known to compromise bone healing, with a mean follow-up of 9.5 months. Ninety-seven percent of the patients demonstrated a successful bony fusion of the joint and 98.9% maintained a stable joint position over the course of the study, which was published in The Journal of Foot & Ankle Surgery. The implant removal rate was 3.1% compared with conventional plate implants where published removal rates can be greater than of 17% for tarsometatarsal and 20% for big-toe joint fusion procedures.
The Lapiplasty procedure is designed to reproducibly correct all three planes of the bunion deformity and address the root cause of the bunion while allowing patients to get back to their active lives quickly. A bunion, or hallux valgus, is a foot deformity that affects about 60 million Americans and results in approximately 400,000 surgeries in the U.S. annually, according to the company.
“This study demonstrated positive bone healing rates over progressive timepoints when utilizing biplanar plating without a cross-joint compression screw in procedures used to treat bunions or arthritis of the big toe joint,” said lead author Dr. Paul Dayton of the Midwest Bunion Center (Des Moines, Iowa), in a prepared statement. “The bone healing rates were quite encouraging, given this unique fixation approach allowed patients to undergo an accelerated recovery protocol and to initiate weightbearing in a post-operative boot within their first week of surgery.
“Overall, I’m very pleased with these results as they reinforce that I can offer this fixation option to my patients with a high level of confidence that they will experience reliable bone healing under an accelerated weight-bearing protocol.”
“The outcomes of this new study are noteworthy in that they closely mirror those reported in our 13-month multicenter dataset presented at the 2018 American Orthopaedic Foot & Ankle Society’s (AOFAS) annual meeting in Boston,” added Dr. Robert Santrock of West Virginia University and co-author on this new publication. “In the AOFAS dataset, the 61 feet treated with Lapiplasty 3D Bunion Correction showed low 1.6% symptomatic non-union rate and 3% radiographic recurrence rate. Patients in the AOFAS study initiated weightbearing in a post-operative boot at an average of 10.5 days, which is consistent with this new study.”
“The rapid time to weightbearing, high rate of bone healing, and low implant removal rate reported in this study further highlight the patient benefits of biplanar plating — the fixation method used in the Lapiplasty procedure,” said Treace Medical CEO John Treace. “The study represents the 9th peer review publication supporting the Lapiplasty procedure, another important milestone for our company.”