Post Market Clinical Follow Up of LEGION™ Primary TKS With VERILAST™ (NCT02380092) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post Market Clinical Follow Up of LEGION™ Primary TKS With VERILAST™
Austria, Germany163 participantsStarted 2015-09
Plain-language summary
LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™ bearing surface (OXINIUM™ femoral component with highly cross-linked polyethylene tibial insert).
All study subjects will receive a LEGION™ Primary Total Knee System with VERILAST™ bearing surface and the results will be analysed against historical data from patients who received a Genesis II knee replacement.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Subject requires primary TKA and has elected to use the LEGION™ Primary TKS with VERILAST™.
* Subject requires primary TKA due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis).
* Subject is of legal age to consent, agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the EC approved informed consent form.
* Routine radiographic assessment is possible.
* Subject plans to be available through ten (10) years postoperative follow-up.
* Subject is 18-75 years of age at the time of surgery.
Exclusion Criteria:
* Age \> 75 years at the time of surgery.
* Subjects with immunosuppressive disorders.
* Subject has severe pronation of the ipsilateral foot or any other relevant clinical condition contributing to abnormal ambulation (including but not limited to ankle fusion, ankle arthroplasty, previous hip fracture, ipsilateral hip arthritis resulting in flexion contracture).
* Subject has undergone a previous major surgery to the study knee (including osteotomy, fracture fix, medial or lateral ligament surgery).
* Subject has active infection or sepsis (treated or untreated).
* At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the Investigator:
* Ipsilateral or contralateral primary total hip arthroplasty or hip…