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Treace Medical Concepts announced the peer-reviewed publication of the four-year interim results from its ALIGN3D multicenter prospective study demonstrating positive clinical and radiographic outcomes of the Lapiplasty Procedure.
The published results, “Four-Year Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing for Hallux Valgus: A Multicenter Prospective Study,” include interim data on 139 of 173 study patients treated with at least four years of follow-up from Lapiplasty® in the prospective, five-year, multicenter ALIGN3D™ clinical study. The data showed:
- Early return to protected weight bearing at an average of 7.7 days and return to athletic shoes at 6.5 weeks;
- Low radiographic recurrence rates of 0.8% using HVA>20° and 8.4% using HVA>15° at 48 months; and
- Continued significant improvement in pain and patient-reported outcome scores, including an 81% improvement in pain and 89% improvement in walking/standing on the MOxFQ scoring system through 48 months.
The ALIGN3D prospective, multicenter, postmarket clinical study is designed to evaluate outcomes of the Lapiplasty 3D Bunion Correction procedure in the surgical management of symptomatic hallux valgus. The study evaluates consistency and reliability of correction of all three dimensions of the bunion deformity with the Lapiplasty Procedure, as well as maintenance of such correction following accelerated return to weight-bearing, initially in a walking boot.
The primary effectiveness endpoint is radiographic recurrence of the hallux valgus deformity. Key secondary endpoints include change in three-dimensional radiographic alignment; clinical radiographic healing; time to start of weight-bearing in a boot and in shoes; pain; quality of life; and range of motion of the big toe joint.
The study enrolled 173 patients, aged 14 to 58 years, at 7 clinical sites in the United States with 13 participating surgeons. Final patient follow-up for the primary endpoint was completed in the first half of 2023, and study completion with 5-year data is expected in 2026.
John T. Treace, CEO, Founder and Chairman of Treace said, “We are pleased to announce this new peer-reviewed publication from our flagship ALIGN3D™ study demonstrating sustained, successful patient outcomes from our proprietary Lapiplasty® Procedure out to four years. This long-term, multicenter, prospective study sets a high standard for a commercial bunion technology and further differentiates Lapiplasty® in the marketplace with surgeons and patients.”
Source: Treace Medical Concepts
Treace Medical Concepts announced the peer-reviewed publication of the four-year interim results from its ALIGN3D multicenter prospective study demonstrating positive clinical and radiographic outcomes of the Lapiplasty Procedure.
The published results, “Four-Year Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early...
Treace Medical Concepts announced the peer-reviewed publication of the four-year interim results from its ALIGN3D multicenter prospective study demonstrating positive clinical and radiographic outcomes of the Lapiplasty Procedure.
The published results, “Four-Year Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing for Hallux Valgus: A Multicenter Prospective Study,” include interim data on 139 of 173 study patients treated with at least four years of follow-up from Lapiplasty® in the prospective, five-year, multicenter ALIGN3D™ clinical study. The data showed:
- Early return to protected weight bearing at an average of 7.7 days and return to athletic shoes at 6.5 weeks;
- Low radiographic recurrence rates of 0.8% using HVA>20° and 8.4% using HVA>15° at 48 months; and
- Continued significant improvement in pain and patient-reported outcome scores, including an 81% improvement in pain and 89% improvement in walking/standing on the MOxFQ scoring system through 48 months.
The ALIGN3D prospective, multicenter, postmarket clinical study is designed to evaluate outcomes of the Lapiplasty 3D Bunion Correction procedure in the surgical management of symptomatic hallux valgus. The study evaluates consistency and reliability of correction of all three dimensions of the bunion deformity with the Lapiplasty Procedure, as well as maintenance of such correction following accelerated return to weight-bearing, initially in a walking boot.
The primary effectiveness endpoint is radiographic recurrence of the hallux valgus deformity. Key secondary endpoints include change in three-dimensional radiographic alignment; clinical radiographic healing; time to start of weight-bearing in a boot and in shoes; pain; quality of life; and range of motion of the big toe joint.
The study enrolled 173 patients, aged 14 to 58 years, at 7 clinical sites in the United States with 13 participating surgeons. Final patient follow-up for the primary endpoint was completed in the first half of 2023, and study completion with 5-year data is expected in 2026.
John T. Treace, CEO, Founder and Chairman of Treace said, “We are pleased to announce this new peer-reviewed publication from our flagship ALIGN3D™ study demonstrating sustained, successful patient outcomes from our proprietary Lapiplasty® Procedure out to four years. This long-term, multicenter, prospective study sets a high standard for a commercial bunion technology and further differentiates Lapiplasty® in the marketplace with surgeons and patients.”
Source: Treace Medical Concepts
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
