
Kuros Biosciences treated the first patient in a prospectively designed, randomized controlled U.S. trial named PROOF, comparing MagnetOs Putty to autograft for posterolateral spine fusion.
This Level 1 quality trial will be the first such U.S. clinical study of MagnetOs for spinal fusion. The putty will be implanted on one side of the spine and the control material, autograft, on the contralateral side. Thirty patients will undergo a two-level instrumented posterolateral fusion.
Iterim analysis will occur once 15 patients have completed their six-month visit with available measurements for the endpoints.
Joost de Bruijn, Chief Executive Officer, said, “We are excited with the start of the clinical trial PROOF, as it aims to provide evidence to further differentiate MagnetOs and drive wider adoption in clinical practice across the globe. It is also an important step in our effort to improve spine fusion by bringing together an unprecedented blend of scientific, pre-clinical and clinical studies to make what can be an unpredictable process much more predictable. ”
Kuros Biosciences treated the first patient in a prospectively designed, randomized controlled U.S. trial named PROOF, comparing MagnetOs Putty to autograft for posterolateral spine fusion.
This Level 1 quality trial will be the first such U.S. clinical study of MagnetOs for spinal fusion. The putty will be implanted on one side of the...
Kuros Biosciences treated the first patient in a prospectively designed, randomized controlled U.S. trial named PROOF, comparing MagnetOs Putty to autograft for posterolateral spine fusion.
This Level 1 quality trial will be the first such U.S. clinical study of MagnetOs for spinal fusion. The putty will be implanted on one side of the spine and the control material, autograft, on the contralateral side. Thirty patients will undergo a two-level instrumented posterolateral fusion.
Iterim analysis will occur once 15 patients have completed their six-month visit with available measurements for the endpoints.
Joost de Bruijn, Chief Executive Officer, said, “We are excited with the start of the clinical trial PROOF, as it aims to provide evidence to further differentiate MagnetOs and drive wider adoption in clinical practice across the globe. It is also an important step in our effort to improve spine fusion by bringing together an unprecedented blend of scientific, pre-clinical and clinical studies to make what can be an unpredictable process much more predictable. ”
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.