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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00839020
• Other study ID #: MIOS-TKR
• Status: Terminated
• Phase: Phase 4
• First received: February 6, 2009
• Last updated: July 25, 2016
• Start date: November 2007
• Est. completion date: January 2013

Study information

• Verified date: July 2016
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: January 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatoid Arthritis

Intervention

Procedure:
• Navigated TKA with a minimally invasive approach
Navigated total knee arthroplasty with a minimally invasive approach
• Navigated TKA with a conventional approach
A navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed

Locations

Country	Name	City	State
Germany	Frank Lampe, MD	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake.		daily measurements for 20 postoperative days	No
Secondary	Range of Motion (ROM)		daily measurements during hospital stay	No
Secondary	Knee Society Score (KSS)		preop, postop	No
Secondary	Oxford Knee Score (OKS)		preop, postop	No
Secondary	WOMAC-Score		preop, postop	No