Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT00839020
Status:
TERMINATED
Last Update Posted:
2016-07-26
First Post:
2009-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA)
Sponsor:
Aesculap AG
Organization:
Study Overview
Official Title:
Comparison of a Minimally Invasive and a Conventional Approach in Computer Assisted Total Knee Arthroplasty.
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Number of patients willing to participate in the study too low
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
50 patients are randomized to two groups who receive a navigated knee prosthesis. Aim of the study is a comparison between a minimally invasive and a conventional approach. In both groups OrthoPilot computer assisted-navigation will be used. Pain intensity as well as concomitant pain medication are monitored during the first 20 postoperative days and will be compared for the two groups. Various scores are surveyed.
Detailed Description:
Accuracy of implant positioning and reconstruction of the mechanical leg axis are major requirements for achieving good long-term results in total knee arthroplasty (TKA). A minimally invasive approach might compromise the accuracy due to lacking intraoperative oversight. The purpose of this study is to compare a minimally invasive TKA approach that was performed under control of a navigation system with a standard navigated approach, with respect to patient pain and range of motion.
All patients receive a Columbus knee prosthesis and in both groups an OrthoPilot navigation system is used to control the alignment. Pain intensity using the Visual Analogue Scale (VAS) and concomitant pain medication intake are documented daily during the first 20 days after operation. As long as the patient is hospitalized the Range of Motion will also be documented daily. Knee society score, oxford score, as well as the WOMAC score are monitored pre- and postoperatively.
All patients receive a Columbus knee prosthesis and in both groups an OrthoPilot navigation system is used to control the alignment. Pain intensity using the Visual Analogue Scale (VAS) and concomitant pain medication intake are documented daily during the first 20 days after operation. As long as the patient is hospitalized the Range of Motion will also be documented daily. Knee society score, oxford score, as well as the WOMAC score are monitored pre- and postoperatively.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: