Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Surgical Procedures, Minimally Invasive, Range of Motion, Articular Arthroplasty, Replacement, Knee
Brief 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.
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.
Interventions
PROCEDURENavigated TKA with a minimally invasive approach
Navigated total knee arthroplasty with a minimally invasive approach
PROCEDURENavigated TKA with a conventional approach
A navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed
Sponsors
Aesculap AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake. | daily measurements for 20 postoperative days |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed