Orthopaedic Data Evaluation Panel (ODEP)
ODEP provide a service evaluation for TKR ratings and award ratings based on ongoing assessment of implant performance (rate of revision), and the number of patients for which principally UK data is available. The registries and clinical studies described in this document report excellent rates of survivorship for the SAIPH® Knee, with cumulative revision rates lower than the average TKR revision rates and among the lowest of all available devices17,43,45.
Within the MatOrtho® philosophy for safe introduction of new technology, the SAIPH® Knee was released with limited availability and under closely monitored use over the first 10 years. To ensure versions of implant brands are reported appropriately, ODEP separate devices into their available constructs. For the SAIPH® Knee, this means separating UK data for SAIPH® Knee procedures with no patella, with a cementless patella and with a cemented patella.
Consequently, cohorts on which ODEP ratings are based for each construct remain small. The SAIPH® Knee is most commonly used in the UK without a patella resurfacing and so a longer rating is available for this construct. In all categories, the SAIPH® Knee revision rates are considerably lower than the requirement for each rating. ODEP ratings are shown in Figure 9. The SAIPH® Knee is demonstrating exceptional performance with a consistent low revision rate and, as the number of patients who receive it grows, is on track to receive an ODEP 10A* rating.
Figure 9: ODEP ratings for SAIPH® Knee constructs.
For those interested in ODEP ratings, further information on ODEP criteria and use of ratings by hospitals can be found on the ODEP website www.odep.org.uk25,50,51.
References
2. Pinskerova V, Maquet P, Freeman MAR. Writings on the knee between 1836 and 1917. J Bone Joint Surg Br. 2000; 82(8):
1100-1102.
3. Iwaki H, Pinskerova V, Freeman MA. Tibiofemoral movement 1: the shapes and relative movements of the femur and tibia in the unloaded cadaver knee. J Bone Joint Surg Br. 2000; 82(8):1189-95.
4. Hill PF, Vedi V, Williams A, Iwaki H, Pinskerova V, Freeman MA. Tibiofemoral movement 2: the loaded and unloaded living knee studied by MRI. J Bone Joint Surg Br. 2000; 82(8):1196-8.
5. Johal P, Williams A, Wragg P, Hunt D, Gedroyc W. Tibio-femoral movement in the living knee. A study of weight bearing and non-weight bearing knee kinematics using ‘interventional’ MRI. J Biomech. 2005; 38(2):269-76.
17. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. 18th Annual Report, 2021: Surgical data to 31 December 2020. www.njrreports.org.uk.
25. Orthopaedic Data Evaluation Panel (ODEP). Latest ODEP ratings can be found at www.odep.org.u
43. Australian Orthopaedic Association National Joint Replacement Registry. Hip, Knee & Shoulder Arthroplasty: 2021 Annual Report. Adelaide: AOA. 2021: Table KT7 https://aoanjrr.sahmri.com.
45. National Joint Registry. Implant Summary Report for the SAIPH® Knee. Summary.Report.KP_Femoral_Saiph.18/02/2022.
50. ODEP criteria introduced in 2018 are explained at: http://www.odep.org.uk/Portals/0/Forms/Criteria/ODEP_Criteria_Knees.pdf.
51. for ODEP statement on use of ratings by hospitals see: www.odep.org.uk/ODEPExplained/toHospitals.aspx.
Resources
SAIPH® Clinical Rationale
SAIPH® Flyer
SAIPH® Operative Technique
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Principles of the SAIPH® 'Medially Stabilised' Knee
The SAIPH® Knee design is based on the principle of medial stability in the normal knee, which has been described in historical literature2 and widely in recent literature3,4,5. In normal, healthy knees the shapes of the medial and lateral tibial condyles are different: the medial side is concave; the lateral side is convex. Stability is provided collectively by the collateral ligaments (MCL and LCL), both cruciate ligaments (ACL and PCL) and the menisci.