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General Orthopaedics

MEDIAL PIVOT DESIGNS AVOID THE NEED FOR LIGAMENT BALANCING – AFFIRMS

Current Concepts in Joint Replacement (CCJR) Winter 2017 Meeting, Orlando, FL, USA, December 2017.



Abstract

INTRODUCTION

Medial ball and socket knee designs have a long history but are not yet widely used. The Saiph medial ball and socket knee passed preclinical testing before an introductory cohort of 20 patients were studied in detail for 2 years. Subsequently a multicenter study was undertaken by the developing surgeons.

METHODS

We report the minimum 5-year follow-up of the first 102 Saiph knee replacements implanted in Australia as part of a step-wise or phased introduction of this device to the market. These 102 consecutive patients were recruited to the study at two centers in Australia. Revisions, complications and adverse events were collected. Patient reported scores including EQ-5D, Oxford Knee Score (OKS), Knee Injury and Osteoarthritis Outcome Score (KOOS) and Kujala and range of motion satisfaction and forgotten joint score were collected. Data were collected pre-operatively and at one to two years post-operatively and at a minimum of five years.

RESULTS

The average age of the patients was 67.2 years (range, 47 to 85) and average BMI was 29. There were 53% female and 47% male patients. There were two revisions performed – one for infection and one for arthrofibrosis. There were no device related failures or adverse events reported. The OKS improved from 21 pre-operatively to 43 post-operatively. KOOS improvement pre-operative to post-operative was 51 to 88 (symptoms), 54 to 94 (pain), 14 to 68 (sport) and 23 to 86 (quality of life). The percentage of patients reporting difficulty negotiating stairs because of their knee decreased from 86% pre-operatively to 5% post-operatively. The percentage of patients reporting a moderate or severe lack of confidence with their knee decreased from 91% pre-operatively to 10% post-operatively.

CONCLUSION

This study demonstrates that this knee replacement design is safe and provides early pain relief and improved function. Patient reported outcome scores which improved post-operatively and were maintained at latest follow-up. Further data is being collected as part of a large, multicenter study to show repeatability in non-designer surgeon hands.