Sam Brusco, Associate Editor02.05.24
Treace Medical Concepts shared three-year interim clinical data from its ALIGN3D post-market study at this year’s American College of Foot and Ankle Surgeons (ACFAS) meeting. The study supported use of its Lapiplasty procedure to treat bunions.
The company also presented interim data from its Mini3D study at the ACFAS meeting.
Treace also submitted its primary endpoint ALIGN3D manuscript to a peer-reviewed foot and ankle journal at the end of 2023, and expects publication this year.
“We are pleased that this three-year data from our prospective, multicenter ALIGN3D study continues to demonstrate sustained, successful patient outcomes from our proprietary Lapiplasty Procedure,” said Treace CEO, founder, and board member John T. Treace “We believe these three-year clinical study results set a high standard for a commercial bunion technology and one that further differentiates Lapiplasty in the marketplace with our surgeons and their patients. We look forward to continuing to expand our market-leading body of clinical evidence, as we advance the standard of care for bunion surgery.”
In September 2023, the company was issued its milestone 50th U.S. patent.
The company also presented interim data from its Mini3D study at the ACFAS meeting.
ALIGN3D Study
The study—entitled “Three-Year Analyses of a Five-Year Prospective Multicenter Study Assessing Radiographic and Patient Reported Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing”—demonstrated interim data from the five-year, multicenter, 173-patient study. Results showed:- Early return to weight bearing in a walking boot at an average 8.4 days
- Low radiographic recurrence rates at latest visit of 0.9% using HVA>20° (1 out of 115) and 5.2% using HVA>15° (6 out of 115)
- 81% reduction in pain measured using the Visual Analog Scale (“VAS”) at 24 months (n=156)
- 86% and 85% improvement in walking/standing and social interaction patient-reported quality of life measures, respectively, using the Manchester-Oxford Foot Questionnaire (“MOxFQ”) through latest subject visit [mean 40.5 months (n=118)]
- Significant improvement in patient reported outcomes across all Patient-Reported Outcomes Measurement Information System (“PROMIS”) domains over time through latest subject visit [mean 40.5 months (n=113)]
- Low symptomatic non-union rate of 1.8% (3 out of 173)
Treace also submitted its primary endpoint ALIGN3D manuscript to a peer-reviewed foot and ankle journal at the end of 2023, and expects publication this year.
Mini3D Study
The presentation—entitled “Interim Analysis of a Prospective Multicenter Study Assessing Radiographic and Patient Outcomes Following a Mini-Open Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing”—included data from 103 enrolled patients using a mini-incision approach (median incision length: 3.5cm) at an average follow-up time of 7.4 months post-procedure. Data showed:- Early return to weight-bearing in a walking boot at an average 7.8 days
- Maintenance of radiographic correction (IMA, HVA, TSP) through 12 months
- Significant reduction in pain (VAS) and significant improvement in patient reported outcomes (MOxFQ) through 12 months
- Favorable scores for scar quality using the Patient and Observer Scar Assessment Scale (POSAS)
“We are pleased that this three-year data from our prospective, multicenter ALIGN3D study continues to demonstrate sustained, successful patient outcomes from our proprietary Lapiplasty Procedure,” said Treace CEO, founder, and board member John T. Treace “We believe these three-year clinical study results set a high standard for a commercial bunion technology and one that further differentiates Lapiplasty in the marketplace with our surgeons and their patients. We look forward to continuing to expand our market-leading body of clinical evidence, as we advance the standard of care for bunion surgery.”
In September 2023, the company was issued its milestone 50th U.S. patent.