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

August 16, 2012 updated by: Singapore General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 168751
        • Singapore General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years after their total knee replacement surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Collaborators

DePuy International

Investigators

  • Principal Investigator: Dr Seng Jin Yeo, MBBS FRCS, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 3, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

August 20, 2012

Last Update Submitted That Met QC Criteria

August 16, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 63214040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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