Study Results
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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COMPLETED
NA
61 participants
INTERVENTIONAL
2017-07-25
2021-06-05
Brief Summary
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The cementless ATTUNE Cruciate Sacrificing (CS) Rotating Platform Knee by DePuy Synthes has been designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. It is expected that the cementless ATTUNE Rotating Platform Knee will have regulatory approval early 2016. Patient inclusion will start after regular approval has been obtained.
The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes (PROMS) of two TKR prostheses: the Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System and the LCS Complete Cementless Cruciate Sacrificing Knee System (rotating platform design), both by DePuy Synthes, Warsaw, Indiana, USA. In this single-blind, randomized non-inferiority trial, 32 patients with the ATTUNE Knee System and 32 patients with LCS Knee System will be included.
The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, The Netherlands. Annually 300 TKA procedures are performed in this department, of which about 95% is Osteo Arthritis (OA). The investigator anticipates that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years.
Main study parameters/endpoints are:
* Migration, measured by means of RSA.
* Patient Reported Outcome Measures by means of questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ATTUNE
Total Knee Replacement Surgery with cementless ATTUNE Rotating Platform Knee Prosthesis by DePuy
ATTUNE Knee Prosthesis by DePuy
Total Knee Replacement (TKR) Surgery with cementless ATTUNE rotating platform Knee Prosthesis by DePuy
LCS Knee Prosthesis by DePuy
Total Knee Replacement Surgery with cementless LCS rotating platform Knee Prosthesis by DePuy
LCS
Total Knee Replacement Surgery with cementless LCS Rotating Platform Knee Prosthesis by DePuy
ATTUNE Knee Prosthesis by DePuy
Total Knee Replacement (TKR) Surgery with cementless ATTUNE rotating platform Knee Prosthesis by DePuy
LCS Knee Prosthesis by DePuy
Total Knee Replacement Surgery with cementless LCS rotating platform Knee Prosthesis by DePuy
Interventions
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ATTUNE Knee Prosthesis by DePuy
Total Knee Replacement (TKR) Surgery with cementless ATTUNE rotating platform Knee Prosthesis by DePuy
LCS Knee Prosthesis by DePuy
Total Knee Replacement Surgery with cementless LCS rotating platform Knee Prosthesis by DePuy
Eligibility Criteria
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Inclusion Criteria
* All consecutive patients ("usual care") are included to prevent selection bias in the migration analysis.
* Patient is capable of giving informed consent and expressing a willingness to comply with this study
Exclusion Criteria
* Status after patellectomy
* In case flexion is less than 90 degrees
* The patient is unable or unwilling to sign the Informed Consent specific to this study
* The patient does not understand the Dutch or English language good enough to participate
* Patients indicated for revision arthroplasty
* Patient is diagnosed with rheumatoid arthritis
21 Years
90 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Spaarne Gasthuis
OTHER
Responsible Party
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Principal Investigators
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Rob G Nelissen, Prof PhD MD
Role: PRINCIPAL_INVESTIGATOR
Dep. Orthopaedics, Leiden University Medical Center
Peter A Nolte, PhD MD
Role: PRINCIPAL_INVESTIGATOR
Dep. Orthopaedics, Spaarne Gasthuis
Edward R Valstar, Prof PhD Msc
Role: PRINCIPAL_INVESTIGATOR
Dep. Orthopaedics, Leiden University Medical Center
Locations
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Spaarne Gasthuis
Hoofddorp, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Countries
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Other Identifiers
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2017.0027
Identifier Type: -
Identifier Source: org_study_id
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