Conventus Orthopaedic has completed patient enrolment in a clinical study of its Conventus DRS Implant, designed as a treatment for common distal radius fractures.
By utilising the Conventus DRS technology, the minimally invasive implant stabilises the fractured bone fragments from within the bone.
The international multicentre study has enrolled 60 patients from six institutions throughout Germany and Switzerland to demonstrate the safety and efficacy of Conventus DRS Implant.
The study measured the effectiveness of the implant in treating a variety of distal radius fractures.
The study results demonstrated early and consistent healing with expected return to function and low complication rates.
Radiographic evidence also demonstrated that healing across the fracture site of all available patients occurred as early as six weeks, while disabilities of the arm shoulder and hand scores showed functional improvement at 12 weeks.
Michael Strassmair, Klinikum Starnberg orthopaedic surgeon, said the Conventus study provides a large set of radiographic and functional data across various surgical patients.
"We expect to use the insights gained from this study to further understand how this new technology can help patients return rapidly to normal function with fewer complications," Strassmair added.
Paul Hindrichs, Conventus Orthopaedics CEO, said the company’s clinical study validates proof of concept and demonstrates the potential of Conventus DRS technology.
"We are now embarking on a European postmarket clinical investigation to further demonstrate the potential of our technology in treating peri-articular fractures, and preparing for broader regulatory approval and commercial launch," Hindrichs added.
The Conventus DRS Implant, which is pending 510(k) clearance by the US Food and Drug Administration, is not yet cleared for distribution in the US, according to the company.