Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements

June 3, 2014 updated by: Cameron Handford, The University of New South Wales
This is a randomised control trial comparing two different prosthetic designs used in total knee arthroplasty. Participants were randomised to receive either of the two prostheses and then were followed up of a period of 7 years, looking at pain, range of motion and impact on quality of life. The literature and joint registry of Australia shows that one of the prosthesis may be inferior to the other. Our research team hypothesised that this was not the case and that previous elicited differences were related to other factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

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

  • Australia
    • New South Wales
      • Port Macquarie, New South Wales, Australia, 2444
        • Dr Dean Pepper, orthopaedic surgeon private rooms

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients presenting to a single orthopaedic surgeon with knee pathology, who were suitable candidates for total knee arthroplasty

Exclusion Criteria:

  • refusal to participate
  • other simultaneous surgery
  • post traumatic osteoarthritis
  • prior open knee surgery

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Randomised group 1
This study is looking at a group of patients with knee osteoarthritis or other pathology requiring total knee arthroplasty. This group of patients were randomised to receive either a mobile bearing prosthesis or a fixed bearing prosthesis.
Device: Fixed bearing prosthesis
Experimental: Randomised group 2
This study is looking at a group of patients with knee osteoarthritis or other pathology requiring total knee arthroplasty. This group of patients were randomised to receive either a mobile bearing prosthesis or a fixed bearing prosthesis.
Device: Mobile bearing prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual pain analogue score
Time Frame: 6 weeks
Participants asked to rate their level of pain on a scale
6 weeks
Range of motion
Time Frame: 6 weeks
The range of motion of the joint was assessed in both flexion and extension
6 weeks
Activities of Daily Living
Time Frame: 6 weeks
Questionnaire looking at how the intervention impacts of activities of daily living
6 weeks
X-ray analysis of joint alignment
Time Frame: 5-7 year
Using X-rays, the knee was assessed for mechanical and anatomical alignment
5-7 year
Visual pain analogue score
Time Frame: 6 months
6 months
visual pain analogue score
Time Frame: 12 months
12 months
visual analogue pain score
Time Frame: 5-7 years
5-7 years
range of motion
Time Frame: 6 months
6 months
range of motion
Time Frame: 1 year
1 year
range of motion
Time Frame: 5-7 years
5-7 years
activities of daily living
Time Frame: 6 months
6 months
activities of daily living
Time Frame: 1 year
1 year
activities of daily living
Time Frame: 5-7 years
5-7 years

Collaborators and Investigators

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

Sponsor

The University of New South Wales

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

May 1, 2005

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 30, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC12098

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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