Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry

NCT ID: NCT02663804

Last Updated: 2018-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Implant design 1

Journey II, BCS, Smith\&Nephew

Group Type ACTIVE_COMPARATOR

Total Knee Arthroplasty

Intervention Type DEVICE

Implant design 2

Persona, Zimmer

Group Type ACTIVE_COMPARATOR

Total Knee Arthroplasty

Intervention Type DEVICE

Implant design 3

Unity, Corin

Group Type ACTIVE_COMPARATOR

Total Knee Arthroplasty

Intervention Type DEVICE

Interventions

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Total Knee Arthroplasty

Intervention Type DEVICE

Other Intervention Names

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Journey II, Smith&Nephew Persona, Zimmer Unity, Corin

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Ghent

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ghent University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EC/2014/0023

Identifier Type: -

Identifier Source: org_study_id

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