Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision

Instability Clinical Trial

— NavRevKnie  

Official title:

Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01601756
• Other study ID #: AAG-I-H-0917
• Status: Recruiting
• Phase: N/A
• First received: May 14, 2012
• Last updated: May 16, 2012
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2012
• Source: Charite University, Berlin, Germany
• Contact: Georg Matziolis, MD
• Phone: +49 30 450 615093
• Email: georg.matziolis[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Hypothesis: navigated revision total knee arthroplasty results in a more precise reconstruction of preoperatively planned joint line than conventional revision total knee arthroplasty (rTKA).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• indication for revision knee arthroplasty

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impingement
• Instability
• Loosening
• or Other Reasons Accepted as Indications for TKA Exchange.
• Revision Total Knee Arthroplasty Because of
• The Focus is to Determine the Precision of Joint Line Restoration in Navigated vs. Conventional Revision Total Knee Arthroplasty

Intervention

Device:
• navigated revision knee arthroplasty
revision knee arthroplasty with the aid of a navigation system the navigation system is the Orthopilot System with a software specifically dedicated for revision operations (TKR 1.0). The system is from Aesculap AG (Tuttlingen).
• conventional revision knee arthroplasty
revision knee arthroplasty using conventional instruments

Locations

Country	Name	City	State
Germany	Orthopaedic Department, Charité - University Medicine Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Additional Sponsor: Aesculap AG (Tuttlingen)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restoration of Joint Line	Difference between preoperatively planned and postoperatively achieved joint line	postoperatively (6 to 12 weeks after operation, we expect a mean of 9 weeks)	No