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

Primary Purpose

Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Navigated TKA with a minimally invasive approach
Navigated TKA with a conventional approach
Sponsored by
Aesculap AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Surgical Procedures, Minimally Invasive, Range of Motion, Articular Arthroplasty, Replacement, Knee

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Frank Lampe, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Navigated total knee arthroplasty with a minimally invasive approach

Navigated total knee arthroplasty with a conventional approach

Outcomes

Primary Outcome Measures

Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake.

Secondary Outcome Measures

Range of Motion (ROM)
Knee Society Score (KSS)
Oxford Knee Score (OKS)
WOMAC-Score

Full Information

First Posted
February 6, 2009
Last Updated
July 25, 2016
Sponsor
Aesculap AG
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1. Study Identification

Unique Protocol Identification Number
NCT00839020
Brief Title
Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA)
Official Title
Comparison of a Minimally Invasive and a Conventional Approach in Computer Assisted Total Knee Arthroplasty.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Number of patients willing to participate in the study too low
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aesculap AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
Keywords
Surgical Procedures, Minimally Invasive, Range of Motion, Articular Arthroplasty, Replacement, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Navigated total knee arthroplasty with a minimally invasive approach
Arm Title
2
Arm Type
Active Comparator
Arm Description
Navigated total knee arthroplasty with a conventional approach
Intervention Type
Procedure
Intervention Name(s)
Navigated TKA with a minimally invasive approach
Other Intervention Name(s)
Navigated MIS TKA
Intervention Description
Navigated total knee arthroplasty with a minimally invasive approach
Intervention Type
Procedure
Intervention Name(s)
Navigated TKA with a conventional approach
Other Intervention Name(s)
Navigated TKA with conventional approach
Intervention Description
A navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed
Primary Outcome Measure Information:
Title
Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake.
Time Frame
daily measurements for 20 postoperative days
Secondary Outcome Measure Information:
Title
Range of Motion (ROM)
Time Frame
daily measurements during hospital stay
Title
Knee Society Score (KSS)
Time Frame
preop, postop
Title
Oxford Knee Score (OKS)
Time Frame
preop, postop
Title
WOMAC-Score
Time Frame
preop, postop

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Lampe, MD
Organizational Affiliation
Schön Kliniken Klinikum Eilbek
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frank Lampe, MD
City
Hamburg
Country
Germany

12. IPD Sharing Statement

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

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