Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA)

Phase 4

Terminated

• Conditions: Post-traumatic Arthritis; Osteoarthritis; Rheumatoid Arthritis
• Interventions: Procedure: Navigated TKA with a minimally invasive approach; Procedure: Navigated TKA with a conventional approach

• Registration Number: NCT00839020
• Lead Sponsor: Aesculap AG

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Primary Completion: 2012-07
• Study Completion: 2013-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Indication for elective TKA
• agreement to participate in this study

Exclusion Criteria

• Body Mass Index (BMI)>40kg/m²
• varus or valgus deformity >20°
• Range of Motion (ROM) <75° flexion/extension
• concomitant diseases like: rheumatoid arthritis osteoporosis intake of cortisone diabetes former operations on the concerned knee
• infections in the operated joint during the follow-up period
• Thromboses during the follow-up period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Navigated TKA with a minimally invasive approach	Navigated total knee arthroplasty with a minimally invasive approach
2	Navigated TKA with a conventional approach	Navigated total knee arthroplasty with a conventional approach

Primary Outcome Measures

Name	Time	Method
Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake.	daily measurements for 20 postoperative days

Secondary Outcome Measures

Name	Time	Method
Range of Motion (ROM)	daily measurements during hospital stay
Knee Society Score (KSS)	preop, postop
Oxford Knee Score (OKS)	preop, postop
WOMAC-Score	preop, postop

Trial Locations

Locations (1)

Frank Lampe, MD; 🇩🇪 Hamburg, Germany