Computer Assisted Total Knee Replacement

Computer Assisted Navigation in Total Knee Arthroplasty

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00279838

Enrollment

200

Registered

2006-01-20

Start date

2004-06-30

Completion date

2007-04-30

Last updated

2011-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Total Knee Arthroplasty

Brief summary

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).

Detailed description

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.

Interventions

PROCEDUREComputer Assisted Navigation Knee Replacement

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To determine whether mechanical axis of the limb malalignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation	—

Secondary

Measure	Time frame
To compare the frontal alignment of the femoral and tibial components from full length standing radiographs	—
To compare sagittal alignment of the femoral and tibial components from lateral radiographs	—
To compare the rotation of the femoral and tibial components from CT Scan.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026