None listed
Conditions
Brief summary
The protocol described a trial comparing the results between fixed versus mobile bearing medial unicompartmental knee replacements. Clinical ourcomes and complications will be investigated with a 15 year follow up.
Interventions
The long-term results of fixed versus mobile bearing medial unicompartmental 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 Southmead Hospital. The fixed bearing medial unicompartmental knee replacement differs from the mobile bearing replacement due to
The long-term results of fixed versus mobile bearing medial unicompartmental 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 Southmead Hospital. The fixed bearing medial unicompartmental knee replacement differs from the mobile bearing replacement due to the fact that there is no mobile bearing component. The anticipated duration of surgery is 1-1.5 hours.
Sponsors
Corin LTD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
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 medial unicompartmental knee replacement. Also, patients’ ability to provide consent form and cooperate throughout the study were necessary.
Exclusion criteria
Exclusion criteria were inflammatory arthritis, significant anterior or lateral knee pain, ACL deficiency, fixed flexion deformity more than 15 degrees, fixed varus deformity, lateral tibial subluxation, flexion range less than 90 degrees, arthritis of the patellofemoral or lateral femorotibial joint of Grade 2 or more. Also, patients with neuropathic arthropathy and / or active sepsis were ruled out. What is more patients with earlier ipsilateral knee surgery other than arthroscopy, meniscectomy or chondroplasty were not considered.
Outcome results
None listed