None listed
Conditions
Brief 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.
Interventions
This study has been designed to utilise a currently operating standard care system of functional and patient-reported data collection in order to compare patient reported outcome measures and satisfaction scores of patients 60 years and over at the time of surgery, receiving a B.Braun Enduro hinged knee prosthesis for osteoarthritis, to age-matched controls receiving a primary conventional B.Braun Columbus unconstrained prosthesis.
Furthermore, to determine early functional outcomes of patient
This study has been designed to utilise a currently operating standard care system of functional and patient-reported data collection in order to compare patient reported outcome measures and satisfaction scores of patients 60 years and over at the time of surgery, receiving a B.Braun Enduro hinged knee prosthesis for osteoarthritis, to age-matched controls receiving a primary conventional B.Braun Columbus unconstrained prosthesis. Furthermore, to determine early functional outcomes of patients receiving a hinged knee prosthesis at day 3, day 14 and 6 weeks post-operative; medium-term patient-reported outcomes at 6 and 12 months post-operative; complication, survival and revision rates following use of the hinged knee prosthesis at 12 months post-operative. This current standard practice of patient-reported outcome measure data collection from each patient may take approximately 20 minutes to complete from a home computer at each interval. Functional measurements completed by physiotherapists occur as part of standard treatment and progress visits. None of these measures occur in addition to standard care or require an additional time commitment than any other Joint Replacement Clinic patient.
Sponsors
The Joint Replacement Clinic
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 60 years and over receiving a primary HTKA prosthesis for advanced OA of the knee (Kellgren-Lawrence grade IV). 2. Patients 60 years and over receiving a primary TKA conventional unconstrained prosthesis for advanced OA of the knee (Kellgren-Lawrence grade IV).
Exclusion criteria
1. Patients receiving a hinged TKA for revision knee surgery. 2. Patients receiving a hinged TKA for Rheumatoid arthritis, neuromuscular disorders or pathologies other than Osteoarthritis. 3. Patients under 60 years of age at the time of surgery.
Outcome results
None listed