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

This study has been terminated.
(Number of patients willing to participate in the study too low)
Sponsor:
Information provided by:
Aesculap AG
ClinicalTrials.gov Identifier:
NCT00839020
First received: February 6, 2009
Last updated: August 6, 2012
Last verified: August 2012

February 6, 2009
August 6, 2012
November 2007
July 2012   (final data collection date for primary outcome measure)
Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake. [ Time Frame: daily measurements for 20 postoperative days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00839020 on ClinicalTrials.gov Archive Site
  • Range of Motion (ROM) [ Time Frame: daily measurements during hospital stay ] [ Designated as safety issue: No ]
  • Knee Society Score (KSS) [ Time Frame: preop, postop ] [ Designated as safety issue: No ]
  • Oxford Knee Score (OKS) [ Time Frame: preop, postop ] [ Designated as safety issue: No ]
  • WOMAC-Score [ Time Frame: preop, postop ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA)
Comparison of a Minimally Invasive and a Conventional Approach in Computer Assisted Total Knee Arthroplasty.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Post-traumatic Arthritis
  • Procedure: Navigated TKA with a minimally invasive approach
    Navigated total knee arthroplasty with a minimally invasive approach
    Other Name: Navigated MIS TKA
  • Procedure: Navigated TKA with a conventional approach
    A navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed
    Other Name: Navigated TKA with conventional approach
  • Active Comparator: 1
    Navigated total knee arthroplasty with a minimally invasive approach
    Intervention: Procedure: Navigated TKA with a minimally invasive approach
  • Active Comparator: 2
    Navigated total knee arthroplasty with a conventional approach
    Intervention: Procedure: Navigated TKA with a conventional approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
26
January 2013
July 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00839020
MIOS-TKR
No
Dr. med. Frank Lampe, Schön Kliniken, Kliniken Eilbek
Aesculap AG
Not Provided
Principal Investigator: Frank Lampe, MD Schön Kliniken Klinikum Eilbek
Aesculap AG
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP