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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DePuy International
Information provided by (Responsible Party):
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01659229
First received: August 3, 2012
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Knee Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fluoroscopic Analysis Comparing the Dynamic Flexion of 2 Different Knee Arthroplasty Implants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: October 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
They are a charity which helps fund research, provides information and campaigns to raise the profile of arthritis. They work with various organisations such as the NHS, Health sciences industry, professional bodies to achieve their goals.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01659229     History of Changes
Other Study ID Numbers: 63214040
Study First Received: August 3, 2012
Last Updated: August 16, 2012
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:
knee osteoarthritis

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

ClinicalTrials.gov processed this record on May 19, 2013