Computer Assisted Total Knee Replacement

Osteoarthritis Clinical Trial

Official title:

Computer Assisted Navigation in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279838
• Other study ID #: 957-04
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2006
• Last updated: March 22, 2011
• Start date: June 2004
• Est. completion date: April 2007

Study information

• Verified date: March 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Total Knee Arthroplasty

Intervention

Procedure:
• Computer Assisted Navigation Knee Replacement

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare the frontal alignment of the femoral and tibial components from full length standing radiographs
Secondary	To compare sagittal alignment of the femoral and tibial components from lateral radiographs
Secondary	To compare the rotation of the femoral and tibial components from CT Scan.