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

Study Overview
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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.

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.

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

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis

Intervention / Treatment
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* Procedure: Navigated TKA with a minimally invasive approach
* Procedure: Navigated TKA with a conventional approach


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Navigated total knee arthroplasty with a minimally invasive approach | Procedure: Navigated TKA with a minimally invasive approach<br>* Navigated total knee arthroplasty with a minimally invasive approach<br>* Other names: Navigated MIS TKA;|
| Active Comparator: 2<br>Navigated total knee arthroplasty with a conventional approach | Procedure: Navigated TKA with a conventional approach<br>* A navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed<br>* Other names: Navigated TKA with conventional approach;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake. |  | daily measurements for 20 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion (ROM) |  | daily measurements during hospital stay | 
| Knee Society Score (KSS) |  | preop, postop | 
| Oxford Knee Score (OKS) |  | preop, postop | 
| WOMAC-Score |  | preop, postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Procedures, Minimally Invasive, Range of Motion, Articular Arthroplasty, Replacement, Knee