Computer Assisted Total Knee Replacement

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

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-04-30

Brief Summary

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The purpose of this study is to determine whether intraoperative computer-assisted navigation improves prosthetic implant positioning as compared to conventional intraoperatve instrumentation in Total Knee Arthroplasty (TKA).

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Detailed Description

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Primary data to be obtained is to determine whether mechanical axis of the limb malignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation.

Three months after surgery follow-up radiographic data will provide evidence on the initial implant position as determined with a series of x-rays including: full length standing, standard AP weight bearing, lateral, patellar, kneelingfilm views and CT evaluation. In addition, a correlation betweeen the CT measures and the kneeling x-ray can be performed at this time. Clinical (Knee Scale Society, WOMAC, and SF-36) data will also be obtained at the three month interval.

Conditions

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Total Knee Arthroplasty Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Computer Assisted Navigation Knee Replacement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Study participants must:

1. Be over 18 years of age.
2. Require a TKA and is considered by the investigator to be a suitable candidate for the specific knee prosthesis identified in protocol.
3. The subject has given consent to the transfer of his/her information to the sponsor.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No