OssDsign has enrolled 200 patients in the PROPEL multi-center prospective spinal fusion registry. PROPEL was initiated in March 2022 to gather real-world data from patients who have been treated with OssDsign Catalyst.
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.
PROPEL is bridging the gap between the device’s performance in premarket clinical trials and its use in routine practice over time. The registry is an essential step in OssDsign’s strategy to collect clinical evidence of its nanosynthetic bone graft OssDsign Catalyst. Since initiation of the PROPEL registry in 2022, clinics have gradually enrolled patients to evaluate the use and outcome of OssDsign Catalyst in real-world clinical practice. The study’s primary endpoint is measuring the rate of spinal fusion, using computer tomography or radiography, 12 months postoperatively. Additionally, patients’ quality of life, neurological function and the clinical safety profile of the spinal implant are recorded.
“This important milestone reflects our ability to collect clinically relevant data and is a direct result of the high level of interest from surgeons to continue using OssDsign Catalyst, resulting in a growing number of patients being included in PROPEL. The collection of robust clinical evidence is a strategic priority for us, in order to demonstrate OssDsign Catalyst’s effectiveness in real-world clinical practice,” commented Morten Henneveld, CEO of OssDsign.
OssDsign continues to accelerate a robust program of gathering clinical evidence anchored by PROPEL and the clinical study TOP FUSION, in which patient enrolment was completed in 2022.
Source: OssDsign
OssDsign has enrolled 200 patients in the PROPEL multi-center prospective spinal fusion registry. PROPEL was initiated in March 2022 to gather real-world data from patients who have been treated with OssDsign Catalyst.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion...
OssDsign has enrolled 200 patients in the PROPEL multi-center prospective spinal fusion registry. PROPEL was initiated in March 2022 to gather real-world data from patients who have been treated with OssDsign Catalyst.
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.
PROPEL is bridging the gap between the device’s performance in premarket clinical trials and its use in routine practice over time. The registry is an essential step in OssDsign’s strategy to collect clinical evidence of its nanosynthetic bone graft OssDsign Catalyst. Since initiation of the PROPEL registry in 2022, clinics have gradually enrolled patients to evaluate the use and outcome of OssDsign Catalyst in real-world clinical practice. The study’s primary endpoint is measuring the rate of spinal fusion, using computer tomography or radiography, 12 months postoperatively. Additionally, patients’ quality of life, neurological function and the clinical safety profile of the spinal implant are recorded.
“This important milestone reflects our ability to collect clinically relevant data and is a direct result of the high level of interest from surgeons to continue using OssDsign Catalyst, resulting in a growing number of patients being included in PROPEL. The collection of robust clinical evidence is a strategic priority for us, in order to demonstrate OssDsign Catalyst’s effectiveness in real-world clinical practice,” commented Morten Henneveld, CEO of OssDsign.
OssDsign continues to accelerate a robust program of gathering clinical evidence anchored by PROPEL and the clinical study TOP FUSION, in which patient enrolment was completed in 2022.
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.