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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Navigated total knee arthroplasty with a minimally invasive approach

Group Type ACTIVE_COMPARATOR

Navigated TKA with a minimally invasive approach

Intervention Type PROCEDURE

Navigated total knee arthroplasty with a minimally invasive approach

2

Navigated total knee arthroplasty with a conventional approach

Group Type ACTIVE_COMPARATOR

Navigated TKA with a conventional approach

Intervention Type PROCEDURE

A navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed

Interventions

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Navigated TKA with a minimally invasive approach

Navigated total knee arthroplasty with a minimally invasive approach

Intervention Type PROCEDURE

Navigated TKA with a conventional approach

A navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed

Intervention Type PROCEDURE

Other Intervention Names

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Navigated MIS TKA Navigated TKA with conventional approach

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No