None listed
Conditions
Brief summary
This study is looking at two different types of knee replacements—fixed bearing and mobile bearing—to see which works better over time. People who need a total knee replacement are randomly given one of the two types. Researchers will follow them for 10 years to see how well their knees function, how much pain they have, and whether any complications occur. They will use standard questionnaires and check for any need to remove or replace the implant. The goal is to find out which type of knee replacement gives better long-term results for patients.
Interventions
The long-term results of fixed versus mobile bearing rotaglide total knee replacements will be compared. The intervention will be delivered by fellowship trained knee surgeons and the minimum number of patients required for that study will be determined by the sample size calculation performed based on the Oxford score. The procedures will be performed at the North Bristol NHS Trust and the University Hospitals Coventry & Warwickshire. The duration of the operation will be 1.5 hours approximatel
The long-term results of fixed versus mobile bearing rotaglide total knee replacements will be compared. The intervention will be delivered by fellowship trained knee surgeons and the minimum number of patients required for that study will be determined by the sample size calculation performed based on the Oxford score. The procedures will be performed at the North Bristol NHS Trust and the University Hospitals Coventry & Warwickshire. The duration of the operation will be 1.5 hours approximately. The fixed bearing medial rotaglide total knee replacement differs from the mobile bearing replacement due to the fact that there is no mobile bearing component.
Sponsors
Corin LTD
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria were male or female patients under 70 years of age undergoing total knee replacement. Also, patients’ ability to provide consent form and cooperate throughout the study were necessary.
Exclusion criteria
Exclusion criteria were inflammatory/rheumatoid arthritis, neuropathic arthropathy and / or active sepsis.
Outcome results
None listed