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

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ClinicalTrials.gov Identifier: NCT01659229
Recruitment Status : Unknown
Verified August 2012 by Singapore General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 7, 2012
Last Update Posted : August 20, 2012
Sponsor:
Collaborator:
DePuy International
Information provided by (Responsible Party):
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.

Condition or disease
Knee Osteoarthritis

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 Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fluoroscopic Analysis Comparing the Dynamic Flexion of 2 Different Knee Arthroplasty Implants
Study Start Date : October 2011
Primary Completion Date : July 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. Flexion-extension range of movement of operated knee [ Time Frame: 2 years after their total knee replacement surgery ]
    Fluoroscopic studies are done as patient perform lunges, squats and climb up and down stairs.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who underwent total knee replacement surgery who received either the PFC CR 150 knee implants or the PFC CR standard knee implant
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659229


Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore General Hospital
DePuy International
Investigators
Principal Investigator: Dr Seng Jin Yeo, MBBS FRCS Singapore General Hospital

Additional Information:
Publications:
Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01659229     History of Changes
Other Study ID Numbers: 63214040
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: August 20, 2012
Last Verified: August 2012

Keywords provided by Singapore General Hospital:
knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases