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Fully Disposable Patient-Specific Instrumentation

NCT ID: NCT02966613

Last Updated: 2016-11-17

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

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-09-30

Brief Summary

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To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with fully disposable patient-specific instrumentation versus conventional, versus patient specific instrumentation.

Detailed Description

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The investigators performed a controlled multicenter trial comparing the clinical and radiologic results and resources consumption of primary TKA using patient-specific cutting guides (PSCG) versus conventional instrumentation (CI), and compared the results to those obtained with a fully disposable patient-specific instrumentation (PSCG-D).

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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CI

TKA using conventional instrumentation (CI)

Group Type ACTIVE_COMPARATOR

GMK Medacta Total Knee arthroplasty

Intervention Type DEVICE

Total Knee arthroplasty

PSCG

TKA performed using Patient specific cutting guides (PSCG)

Group Type EXPERIMENTAL

GMK Medacta Total Knee arthroplasty

Intervention Type DEVICE

Total Knee arthroplasty

PSCG-D

TKA performed using fully disposable Patient specific cutting guides (PSCG-D)

Group Type EXPERIMENTAL

GMK Medacta Total Knee arthroplasty

Intervention Type DEVICE

Total Knee arthroplasty

Interventions

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GMK Medacta Total Knee arthroplasty

Total Knee arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients 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
* 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, Professor of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Abane L, Zaoui A, Anract P, Lefevre N, Herman S, Hamadouche M. Can a Single-Use and Patient-Specific Instrumentation Be Reliably Used in Primary Total Knee Arthroplasty? A Multicenter Controlled Study. J Arthroplasty. 2018 Jul;33(7):2111-2118. doi: 10.1016/j.arth.2018.02.038. Epub 2018 Feb 17.

Reference Type DERIVED
PMID: 29576488 (View on PubMed)

Other Identifiers

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SC2900

Identifier Type: -

Identifier Source: org_study_id