Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry

Ghent University Hospital (UZ)

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: Total Knee Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02663804

EC/2014/0023

Details and patient eligibility

About

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.

Enrollment: 380 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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380 participants in 3 patient groups

Implant design 1

Active Comparator group

Description:

Journey II, BCS, Smith&Nephew

Treatment:

Device: Total Knee Arthroplasty

Implant design 2

Active Comparator group

Description:

Persona, Zimmer

Treatment:

Device: Total Knee Arthroplasty

Implant design 3

Active Comparator group

Description:

Unity, Corin

Treatment:

Device: Total Knee Arthroplasty