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

Knee Osteoarthritis Clinical Trial

Official title:

Fluoroscopic Analysis Comparing the Dynamic Flexion of 2 Different Knee Arthroplasty Implants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01659229
• Other study ID #: 63214040
• Status: Active, not recruiting
• Phase: N/A
• First received: August 3, 2012
• Last updated: August 16, 2012
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 95 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	DePuy International

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

Nicholls RL, Schirm AC, Jeffcote BO, Kuster MS. Tibiofemoral force following total knee arthroplasty: comparison of four prosthesis designs in vitro. J Orthop Res. 2007 Nov;25(11):1506-12. Erratum in: J Orthop Res. 2008 Apr;26(4):578. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flexion-extension range of movement of operated knee	Fluoroscopic studies are done as patient perform lunges, squats and climb up and down stairs.	2 years after their total knee replacement surgery	No

External Links

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