M17 Z96
Conditions
Interventions
Group 1: Legion Revision System (Smith & Nephew Inc, Memphis, TN)
Group 2: RT-Plus system (Smith & Nephew Inc, Memphis, TN)
Sponsors
KH MOL GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Indications are: - Rheumatoid arthritis - Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result - Failed osteotomies, unicompartmental replacement, or total knee replacement In addition, the patient has to fulfil the following criteria to be eligible for the study: - The patient is scheduled for elective primary or revision knee arthroplasty - The patient is 18 years or older. There are no upper age limits for the study, as long as the patient is healthy enough to undergo surgery - The patient is willing to provide informed consent
Exclusion criteria
Exclusion criteria: - The patient participates in another concurrent study - Major psychiatric disease - Patients who do not comprehend the German language (read and speak) - Pregnancy, lactation, or childbearing potential without using adequate contraception - Acute or chronic infections, local or systemic (or corresponding previous incidents) - Severe muscle, nerve, or vascular diseases that endanger the extremity in question - Lacking bone substance or possessing inadequate bone quality that endangers a stable seating of the prosthesis - Extreme insufficiency of the knee extensor mechanism - Adipositas permagna - Local tumours - Known hypersensitivity to the material
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative functional outcome as measured by the Knee Injury and Osteoarthritis Outcome Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative joint awareness during various activities of daily living as measured by the Forgotten Joint Score-12, the Knee Society Score, along with the incidence and location of radiolucent lines using the Knee Society Total Knee Arthroplasty Radiographic Evaluation System. | — |
Countries
Germany
Contacts
Public ContactHagen Hommel
KH MOL GmbH
Outcome results
None listed