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

July 25, 2016 updated by: Aesculap AG

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Frank Lampe, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Navigated total knee arthroplasty with a minimally invasive approach
Procedure: Navigated TKA with a minimally invasive approach
Navigated total knee arthroplasty with a minimally invasive approach
Other Names:
  • Navigated MIS TKA
Active Comparator: 2
Navigated total knee arthroplasty with a conventional approach
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 Names:
  • Navigated TKA with conventional approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake.
Time Frame: daily measurements for 20 postoperative days
daily measurements for 20 postoperative days

Secondary Outcome Measures

Outcome Measure
Time Frame
Range of Motion (ROM)
Time Frame: daily measurements during hospital stay
daily measurements during hospital stay
Knee Society Score (KSS)
Time Frame: preop, postop
preop, postop
Oxford Knee Score (OKS)
Time Frame: preop, postop
preop, postop
WOMAC-Score
Time Frame: preop, postop
preop, postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Investigators

  • Principal Investigator: Frank Lampe, MD, Schön Kliniken Klinikum Eilbek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (Estimate)

February 9, 2009

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIOS-TKR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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