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

Aesculap

Status and phase: Terminated; Phase 4

Conditions: Osteoarthritis; Post-traumatic Arthritis; Rheumatoid Arthritis

Treatments: Procedure: Navigated TKA with a conventional approach; Procedure: Navigated TKA with a minimally invasive approach

Study type: Interventional

Funder types: Industry

Identifiers

NCT00839020

MIOS-TKR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

1

Active Comparator group

Description:

Navigated total knee arthroplasty with a minimally invasive approach

Treatment:

Procedure: Navigated TKA with a minimally invasive approach

2

Active Comparator group

Description:

Navigated total knee arthroplasty with a conventional approach

Treatment:

Procedure: Navigated TKA with a conventional approach