This trial is active, not recruiting.

Condition knee osteoarthritis
Sponsor Singapore General Hospital
Collaborator DePuy International
Start date October 2011
End date July 2012
Trial size 12 participants
Trial identifier NCT01659229, 63214040


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Study group implant: PFC CR 150 Control group implant: PFC CR standard
study group implant: PFC CR 150 control group implant: PFC CR Standard

Primary Outcomes

Flexion-extension range of movement of operated knee
time frame: 2 years after their total knee replacement surgery

Eligibility Criteria

Male or female participants from 50 years up to 95 years old.

Inclusion Criteria: - All patients who underwent total knee replacement surgery who received either the PFC CR 150 knee implants or the PFC CR standard knee implant - Surgery more than 2 years - Able to walk, climb stairs Exclusion Criteria: - Knee stiffness with less than 100 degrees of knee range of movement - Patients who required revision surgery - Patients who received an all polyethylene tibial insert - Patients who received rotating platform tibial tray

Additional Information

Official title Fluoroscopic Analysis Comparing the Dynamic Flexion of 2 Different Knee Arthroplasty Implants
Principal investigator Dr Seng Jin Yeo, MBBS FRCS
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Singapore General Hospital.