A new standard for the safe introduction of orthopaedic implants: Beyond compliance, the unity knee
ESSKA Academy. Matthews E. Nov 9, 2019; 286389
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A new standard for the safe introduction of orthopaedic implants: Beyond compliance, the unity knee

EKA Free Papers

Topic: TKA

Matthews E., Napier R., Patel N., Phillips J., Toms A.
Exeter Knee Reconstruction Unit, Exeter, United Kingdom

Introduction: Beyond Compliance (BC) was introduced in 2012 to improve the monitoring and regulation of all new medical devices and techniques. Its aim was to ensure patient safety whilst promoting development and innovation through an evidence based appraisal of devices during their early introduction. This study reports the 2 year outcomes of the first Total Knee Replacement (TKR) implant to be assessed through the Beyond Compliance process.
Methods: With ethical board approval and patient consent, 100 consecutive patients undergoing primary knee arthroplasty were reviewed. All patients received a single radius cruciate retaining TKA (Unity, Corin), and the patella was resurfaced in all cases. Patients were followed up at 6 weeks, 3, 6, 12 and 24 months post operatively. Pre and post-operative range of movement (ROM) as well as outcome scores including OKS, KOOS, EQ5D index and EQ5D VAS were recorded.
Results: 100 patients (62 females) with a mean age 73.6 (SD=8.7) were included in the analysis. 52 patients underwent a measured resection technique with the remaining 48 being gap balanced. 2 patients died during the follow-up period due to unrelated reasons. Overall satisfaction rates were 96%. Complications included, ongoing pain (5 patients), and a periprosthetic fracture (1 patient) nine months post-surgery following a fall. No knees were revised during the follow-up period. Improvements were observed in all outcomes measures (OKS, KOOS, EQ5D, and EQ5D VAS) compared with pre-operative scores. The mean (SD) ROM (degrees) pre-operatively was 102.3°(14.2°) and post-operatively 115.5°(10.6°).
Discussion: The Unity Knee has been demonstrated to be safe and effective with excellent early outcomes. The careful regulated introduction of this device through the Beyond Compliance process has ensured patients safety while supporting innovation in knee arthroplasty. The success of Beyond Compliance requires surgeons to insist industry fully engage with the process for all new devices or techniques.
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