Fluoroscopic Analysis of PFC CR 150 Versus Standard PFC CR Total Knee Arthroplasty Implants in Deep Flexion
Recruitment status was Active, not recruiting
The investigators are comparing the range of movements the knees of patients who had total knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee system designed to combine function with wear resistance. It can accommodate up to 150 degrees of knee flexion. In the cohort arm, the implant used was the standard Sigma CR which can accommodate up to 120 degrees of flexion.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Fluoroscopic Analysis Comparing the Dynamic Flexion of 2 Different Knee Arthroplasty Implants|
- Flexion-extension range of movement of operated knee [ Time Frame: 2 years after their total knee replacement surgery ] [ Designated as safety issue: No ]Fluoroscopic studies are done as patient perform lunges, squats and climb up and down stairs.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
PFC CR 150 total knee implant
Study group implant: PFC CR 150 Control group implant: PFC CR standard
PFC CR Standard
study group implant: PFC CR 150 control group implant: PFC CR Standard
Both sets of patients will undergo routine post-operative follow up in clinic. The study involves patients who had their surgery more than 2 years ago. We assess their range of movement using fluoroscopy. They are asked to perform lunges, squats and climbing up and down 3 steps. The fluoroscopic images are then analysed to assess their individual range of movements.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659229
|Singapore General Hospital|
|Singapore, Singapore, 168751|
|Principal Investigator:||Dr Seng Jin Yeo, MBBS FRCS||Singapore General Hospital|