Status:
TERMINATED
Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA)
Lead Sponsor:
Aesculap AG
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
Phase:
PHASE4
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 c...
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 approac...
Eligibility Criteria
Inclusion
- Indication for elective TKA
- agreement to participate in this study
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00839020
Start Date
November 1 2007
End Date
January 1 2013
Last Update
July 26 2016
Active Locations (1)
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1
Frank Lampe, MD
Hamburg, Germany