Functional and self-reported outcomes of primary total knee arthroplasty in osteoarthritis comparing two variations of the B.Braun prosthesis used in standard care - Trial ANZCTR12623000157673

Timeline & Enrollment

Primary Outcome

To compare patient functional outcomes using the Oxford Knee Score (OKS) at 6 weeks post-operative in the hinged TKA group, as compared to SC. These questionnaires are completed by all patients via a secure electronic database as per standard care.

Summary

In this study we are trying to find out whether 2 different types of knee joint prostheses have the same clinical and functional outcomes for patients 60 years or over at the time of surgery. Once patient and surgeon decide that the patient will undergo total knee replacement with a B.Braun knee replacement prosthesis; depending on the structural features of the joint, the patient may be receiving either a B.Braun Enduro if additional stability is required, or a B.Braun Columbus prosthesis. The purpose of this study is to compare the outcomes of these two variations of the B.Braun prosthesis when considering patient related factors and the complexity of surgery. This study will analyse outcomes, satisfaction, survival, complication, and revision rates of patients 60 years or over who receive the B.Braun Enduro hinged prosthesis, as compared to an age-matched standard care group who receive the B.Braun Columbus prosthesis. This study will collect data at baseline, day 3, day 14, 6 weeks, 6 months and 12 months post-operative. These devices are both used as standard care globally and are not experimental. All components of these devices can be found on the Australian Register of Therapeutic Goods (ARTG) under B.Braun Australia Pty Ltd EnduRo or Columbus.

ICD-10 Classifications