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% 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. This analysis was independently conducted based on NJR data.
“While the entire CORAIL 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 were announced today coinciding with the 2nd World Arthroplasty Congress (April 19-21, Rome). They 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.
DePuy Synthes commissioned this analysis, known as a Bespoke Implant Report, to provide the orthopaedic community with new outcomes data on one of its most widely used implants. Since 1986, the CORAIL Hip System has been provided to more than two million patients around the world 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.
According to this analysis, results at 10 years showed:
- The CORAIL Standard Collarless Femoral Stem had a cumulative revision rate of 4.0% (96% survivorship rate). This revision rate was statistically equivalent to all other uncemented stems on the NJR (p=0.175).
- The CORAIL Standard Collared Femoral Stem had a cumulative revision rate of 2.7% (97.3% survivorship rate). This revision rate was statistically significantly lower when compared to all other uncemented stems on the NJR (p=<0.001).
- Patients receiving the CORAIL Standard Collared Femoral Stem were 29% 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).
- 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). Each of these complications is among the most common reasons for revision for total hip replacement on the NJR.