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Patient-Specific Versus Conventional Instrumentation in TKA

NCT ID: NCT02002624

Last Updated: 2013-12-06

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-07-31

Brief Summary

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The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the clinical and radiologic results of primary total knee arthroplasty (TKA) using patient-specific versus conventional instrumentation.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional

Conventional instrumentation

Group Type ACTIVE_COMPARATOR

Conventional instrumentation

Intervention Type DEVICE

PSI

Patient specific instrumentation

Group Type EXPERIMENTAL

PSI

Intervention Type DEVICE

Interventions

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PSI

Intervention Type DEVICE

Conventional instrumentation

Intervention Type DEVICE

Other Intervention Names

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Patient specific instrumentation

Eligibility Criteria

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Inclusion Criteria

* patients with primary or secondary osteoarthritis of the knee requiring total knee arthroplasty
* aged between 18 and 85 years
* able to understand information
* affiliated to social security.

Exclusion Criteria

* active or suspected sepsis
* tumor around the knee
* previous partial or total knee replacement
* presence of hardware that could artifact MRI
* contraindication to MRI
* extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
* social situation that could impair follow-up.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochin Hospital

AMBIG

Sponsor Role lead

Responsible Party

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Moussa Hamadouche

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephane Boisgard, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Clermont-Ferrand

Other Identifiers

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CCP SC 2837

Identifier Type: -

Identifier Source: org_study_id