Fluoroscopic Analysis of PFC CR 150 Versus Standard PFC CR Total Knee Arthroplasty Implants in Deep Flexion

• Conditions: Knee Osteoarthritis

• Registration Number: NCT01659229
• Lead Sponsor: Singapore General Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-07
• Status Verified: 2012-08
• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-07
• Last Update Submitted: 2012-08-16
• Last Update Posted: 2012-08-20
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Flexion-extension range of movement of operated knee	2 years after their total knee replacement surgery	Fluoroscopic studies are done as patient perform lunges, squats and climb up and down stairs.

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore