Clinical trial NCT00839020: Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA)
Official title: Comparison of a Minimally Invasive and a Conventional Approach in Computer Assisted Total Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Keywords: Surgical Procedures, Minimally Invasive
Range of Motion
Articular Arthroplasty, Replacement, Knee
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2009-02-09
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake.
timeFrame: daily measurements for 20 postoperative days
Secondary outcomes:
measure: Range of Motion (ROM)
timeFrame: daily measurements during hospital stay
measure: Knee Society Score (KSS)
timeFrame: preop, postop
measure: Oxford Knee Score (OKS)
timeFrame: preop, postop
measure: WOMAC-Score
timeFrame: preop, postop
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Frank Lampe, MD
Study officials:
affiliation: Schön Kliniken Klinikum Eilbek
name: Frank Lampe, MD
role: PRINCIPAL_INVESTIGATOR
References: