Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry

March 7, 2018 updated by: University Hospital, Ghent
A RCT (randomized controlled trial) comparing 3 different TKA (total knee arthroplasty) implant designs and investigating the relation between patient satisfaction and the implant geometry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

380

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

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients of all ages, scheduled for TKA
  • Primary osteoarthritis of the knee joint
  • post traumatic arthritis
  • rheumatoid arthritis

Exclusion Criteria:

  • previous TKA in same joint
  • evidence of neuromuscular or neurosensory deficiency
  • immunologic suppression

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Implant design 1
Journey II, BCS, Smith&Nephew
Device: Total Knee Arthroplasty
Other Names:
  • Journey II, Smith&Nephew
  • Persona, Zimmer
  • Unity, Corin
Active Comparator: Implant design 2
Persona, Zimmer
Device: Total Knee Arthroplasty
Other Names:
  • Journey II, Smith&Nephew
  • Persona, Zimmer
  • Unity, Corin
Active Comparator: Implant design 3
Unity, Corin
Device: Total Knee Arthroplasty
Other Names:
  • Journey II, Smith&Nephew
  • Persona, Zimmer
  • Unity, Corin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: Preop
Determining patient specific factors by use of validated questionnaires
Preop
Patient Satisfaction
Time Frame: 3 months postoperative
Determining patient specific factors by use of validated questionnaires
3 months postoperative
Patient Satisfaction
Time Frame: 6 months postoperative
Determining patient specific factors by use of validated questionnaires
6 months postoperative
Patient Satisfaction
Time Frame: 1 year postoperative
Determining patient specific factors by use of validated questionnaires
1 year postoperative
Patient Satisfaction
Time Frame: 2 years postoperative
Determining patient specific factors by use of validated questionnaires
2 years postoperative

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Collaborators

University Ghent

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

April 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 8, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2014/0023

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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