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OssDsign has reached its target of 300 enrolled patients in the multicenter, prospective spinal fusion registry PROPEL. This registry, initiated in March 2022, collects real-world data from patients treated with OssDsign Catalyst.
PROPEL is closing the gap between the device’s performance in preclinical animal models and its application in routine clinical practice over time. The study’s primary endpoint is to measure the rate of spinal fusion using computed tomography or radiography at 12 months post-op. Additionally, the study will assess patients’ quality of life and neurological function, as well as record the clinical safety profile of the spinal implant.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion surgeries. The graft is composed of a proprietary nanocrystalline structure, which is resorbed and replaced by new and healthy bone tissue. The product was launched in the U.S. in 2021. The market clearance in the U.S. is based on preclinical results that surpass what is typically seen with other synthetic bone grafts in the most demanding preclinical model for spinal fusion – the Boden model. OssDsign continues to accelerate a robust program of gathering clinical evidence anchored by PROPEL, a U.S.-based multi-center prospective spinal fusion registry, and TOP FUSION, in which patient enrollment was completed in April 2022.
“When we initiated the PROPEL registry, we communicated a target of 300 patients. Reaching this milestone already confirms our capability to gather clinically relevant data and the successful enrollment is a direct result of surgeons’ high interest in collaborating with OssDsign to evaluate OssDsign Catalyst. Collecting solid clinical evidence is a strategic priority for us to demonstrate the effectiveness of OssDsign Catalyst in real-world clinical settings and we will therefore continue to enroll patients in the registry to build more and stronger evidence over time,” stated Morten Henneveld, CEO of OssDsign.
Source: OssDsign
OssDsign has reached its target of 300 enrolled patients in the multicenter, prospective spinal fusion registry PROPEL. This registry, initiated in March 2022, collects real-world data from patients treated with OssDsign Catalyst.
PROPEL is closing the gap between the device's performance in preclinical animal models and its application in...
OssDsign has reached its target of 300 enrolled patients in the multicenter, prospective spinal fusion registry PROPEL. This registry, initiated in March 2022, collects real-world data from patients treated with OssDsign Catalyst.
PROPEL is closing the gap between the device’s performance in preclinical animal models and its application in routine clinical practice over time. The study’s primary endpoint is to measure the rate of spinal fusion using computed tomography or radiography at 12 months post-op. Additionally, the study will assess patients’ quality of life and neurological function, as well as record the clinical safety profile of the spinal implant.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion surgeries. The graft is composed of a proprietary nanocrystalline structure, which is resorbed and replaced by new and healthy bone tissue. The product was launched in the U.S. in 2021. The market clearance in the U.S. is based on preclinical results that surpass what is typically seen with other synthetic bone grafts in the most demanding preclinical model for spinal fusion – the Boden model. OssDsign continues to accelerate a robust program of gathering clinical evidence anchored by PROPEL, a U.S.-based multi-center prospective spinal fusion registry, and TOP FUSION, in which patient enrollment was completed in April 2022.
“When we initiated the PROPEL registry, we communicated a target of 300 patients. Reaching this milestone already confirms our capability to gather clinically relevant data and the successful enrollment is a direct result of surgeons’ high interest in collaborating with OssDsign to evaluate OssDsign Catalyst. Collecting solid clinical evidence is a strategic priority for us to demonstrate the effectiveness of OssDsign Catalyst in real-world clinical settings and we will therefore continue to enroll patients in the registry to build more and stronger evidence over time,” stated Morten Henneveld, CEO of OssDsign.
Source: OssDsign
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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.
