DePuy Synthes Inc.04.30.18
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, announced today clinical results associated with the use of its CORAIL Hip System Femoral Stems. Results showed that both the collarless and collared versions of the CORAIL Cementless Stem performed in line with industry expectations and that the CORAIL Standard Collared stem was associated with a 29 percent lower revision risk when compared to all other cementless stems on the National Joint Registry (NJR) for England, Wales, Northern Ireland and the Isle of Man.1,2 This analysis was independently conducted based on Nnational Joint Registry (NJR) data.
“While the entire CORAIL Hip portfolio has a long and successful clinical heritage, this latest information is significant as it reinforces that using a proven, robust construct design with a strong supportive evidence base may help reduce the revision risk for patients and the associated cost burden to healthcare systems,” said Torbjorn Sköld, vice president, DePuy Synthes EMEA Joint Reconstruction.
The results of this analysis come at a time when the number of primary hip replacement procedures performed around the world is anticipated to be approximately 1.7 million in 2018.3
DePuy Synthes commissioned this analysis, known as a Bespoke Implant Report, to provide the orthopedic community with new outcomes data on one of its most widely used implants. Since 1986, the CORAIL Hip System has been provided for more than 2 million patients around the world4 and is an integral part of the DePuy Synthes hip portfolio.
In this analysis, the survivorship rates of the CORAIL Standard Collared and Collarless Femoral Stems were retrospectively compared to all other cementless femoral stems in the NJR. In all, the analysis encompassed more than 130,000 CORAIL Femoral Stem Implantations.
Results at 10 years showed:
The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent a breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides a comprehensive orthopedic portfolio of solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine. DePuy Synthes represents the products and services of DePuy Synthes Inc. and its affiliates. The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, and cardiovascular businesses within Johnson & Johnson's Medical Devices segment.
References
1. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. Implant Bespoke Report for DePuy CORAIL Stem (Standard Offset Collared). NJR Database extract December 8, 2017. Pages 1-15. Licensed for use until Dec. 29, 2018. Available at: www.CORAILevidence.com
2. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. Implant Bespoke Report for DePuy CORAIL Stem (Standard Offset Non-Collared). NJR Database extract December 8, 2017. Pages 1-15. Licensed for use until Dec. 29, 2018. Available at: www.CORAILevidence.com
3. ©2018 Global Data – 39 Country Hip Reconstruction Market Model Dataset.
4. TSM Reports, CORAIL WW implantations YTD 1986-2016.
5. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, 14th Annual Report, 2017. Table 3.10. Available from: www.njrreports.org.uk
“While the entire CORAIL Hip portfolio has a long and successful clinical heritage, this latest information is significant as it reinforces that using a proven, robust construct design with a strong supportive evidence base may help reduce the revision risk for patients and the associated cost burden to healthcare systems,” said Torbjorn Sköld, vice president, DePuy Synthes EMEA Joint Reconstruction.
The results of this analysis come at a time when the number of primary hip replacement procedures performed around the world is anticipated to be approximately 1.7 million in 2018.3
DePuy Synthes commissioned this analysis, known as a Bespoke Implant Report, to provide the orthopedic community with new outcomes data on one of its most widely used implants. Since 1986, the CORAIL Hip System has been provided for more than 2 million patients around the world4 and is an integral part of the DePuy Synthes hip portfolio.
In this analysis, the survivorship rates of the CORAIL Standard Collared and Collarless Femoral Stems were retrospectively compared to all other cementless femoral stems in the NJR. In all, the analysis encompassed more than 130,000 CORAIL Femoral Stem Implantations.
Results at 10 years showed:
- The CORAIL Standard Collarless Femoral Stem had a cumulative revision rate of 4 percent (96 percent survivorship rate). This revision rate was statistically equivalent to all other uncemented stems on the NJR (p=0.175).2
- The CORAIL Standard Collared Femoral Stem had a cumulative revision rate of 2.7 percent (97.3 percent survivorship rate). This revision rate was statistically significantly lower when compared to all other uncemented stems on the NJR (p=<0.001).1
- Patients receiving the CORAIL Standard Collared Femoral Stem were 29 percent less likely to be revised when compared to all other uncemented stems on the NJR (HR 0.71 (0.66, 0.76, p=<0.001).1
- The CORAIL Standard Collared Femoral Stem had significantly lower than expected rates of revision due to pain, dislocation, aseptic loosening and periprosthetic fracture when compared to all other uncemented stems on the NJR (p=<0.001).1 Each of these complications is among the most common reasons for revision for total hip replacement on the NJR.5
The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent a breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides a comprehensive orthopedic portfolio of solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine. DePuy Synthes represents the products and services of DePuy Synthes Inc. and its affiliates. The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, and cardiovascular businesses within Johnson & Johnson's Medical Devices segment.
References
1. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. Implant Bespoke Report for DePuy CORAIL Stem (Standard Offset Collared). NJR Database extract December 8, 2017. Pages 1-15. Licensed for use until Dec. 29, 2018. Available at: www.CORAILevidence.com
2. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. Implant Bespoke Report for DePuy CORAIL Stem (Standard Offset Non-Collared). NJR Database extract December 8, 2017. Pages 1-15. Licensed for use until Dec. 29, 2018. Available at: www.CORAILevidence.com
3. ©2018 Global Data – 39 Country Hip Reconstruction Market Model Dataset.
4. TSM Reports, CORAIL WW implantations YTD 1986-2016.
5. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, 14th Annual Report, 2017. Table 3.10. Available from: www.njrreports.org.uk