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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
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
 Procedure: Navigated TKA with a minimally invasive approach
Procedure: Navigated TKA with a conventional approach
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of a Minimally Invasive and a Conventional Approach in Computer Assisted Total Knee Arthroplasty.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: November 2007
Estimated Study Completion Date: January 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Navigated TKA with conventional approach

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839020

Locations
Germany
Frank Lampe, MD
Hamburg, Germany
Sponsors and Collaborators
Aesculap AG
Investigators
Principal Investigator: Frank Lampe, MD Schön Kliniken Klinikum Eilbek
  More Information

No publications provided

Responsible Party: Dr. med. Frank Lampe, Schön Kliniken, Kliniken Eilbek
ClinicalTrials.gov Identifier: NCT00839020     History of Changes
Other Study ID Numbers: MIOS-TKR
Study First Received: February 6, 2009
Last Updated: August 6, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Aesculap AG:
Surgical Procedures, Minimally Invasive
Range of Motion
Articular Arthroplasty, Replacement, Knee

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013