NCT02663804

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

3.7 years

First QC Date

January 7, 2016

Last Update Submit

March 7, 2018

Conditions

Osteoarthritis

Keywords

Total Knee ArthroplastyPatient SatisfactionPROMsImplant Design

Outcome Measures

Primary Outcomes (5)

  • Patient Satisfaction

    Determining patient specific factors by use of validated questionnaires

    Preop

  • Patient Satisfaction

    Determining patient specific factors by use of validated questionnaires

    3 months postoperative

  • Patient Satisfaction

    Determining patient specific factors by use of validated questionnaires

    6 months postoperative

  • Patient Satisfaction

    Determining patient specific factors by use of validated questionnaires

    1 year postoperative

  • Patient Satisfaction

    Determining patient specific factors by use of validated questionnaires

    2 years postoperative

Study Arms (3)

Implant design 1

ACTIVE COMPARATOR

Journey II, BCS, Smith\&Nephew

Device: Total Knee Arthroplasty

Implant design 2

ACTIVE COMPARATOR

Persona, Zimmer

Device: Total Knee Arthroplasty

Implant design 3

ACTIVE COMPARATOR

Unity, Corin

Device: Total Knee Arthroplasty

Interventions

Total Knee ArthroplastyDEVICE
Also known as: Journey II, Smith&Nephew, Persona, Zimmer, Unity, Corin
Implant design 1Implant design 2Implant design 3

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

OsteoarthritisPatient Satisfaction

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 26, 2016

Study Start

April 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 8, 2018

Record last verified: 2018-03

Locations

BE(1)