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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 6, 2009

Last Updated Date

August 6, 2012

Start Date ^ICMJE

November 2007

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00839020 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Comparison of a Minimally Invasive and a Conventional Approach in Computer Assisted Total Knee Arthroplasty.

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

January 2013

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00839020

Other Study ID Numbers ^ICMJE

MIOS-TKR

Has Data Monitoring Committee

Responsible Party

Dr. med. Frank Lampe, Schön Kliniken, Kliniken Eilbek

Study Sponsor ^ICMJE

Aesculap AG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Frank Lampe, MD

Schön Kliniken Klinikum Eilbek

Information Provided By

Aesculap AG

Verification Date

August 2012

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

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