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This investigation is intended to provide clinical information about alignment using TruMatchâ„¢ and to compare the results to a conventional total knee replacement. TruMatchâ„¢ will be compared to a historical control study, which compares alignment results of computer aided surgery (CAS) and conventional surgical techniques.
The purpose of this investigation is to determine whether TruMatchâ„¢ alignment is non-inferior to alignment achieved with conventional instrumentation. This investigation will compare long leg alignment in total knee replacement achieved by the two types of procedures. Radiographic analysis will be performed by the same IRR as the historical control study.
The study is designed as a prospective, multi-center, non-randomized, clinical investigation to determine whether TruMatchâ„¢ alignment is non-inferior to alignment achieved in a recently completed study (historical control) with conventional instrumentation.
Each enrolled Subject will undergo a total knee replacement using the TruMatchâ„¢ surgical technique. This investigation will require the Subject to be followed once postoperatively to collect radiographs. Follow-up will occur typically 2 to 12 weeks after surgery and when the Subject can achieve full leg extension (=/-5 degrees) and can tolerate weight-bearing.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
TruMatchâ„¢ Personalized Solutions
Towson Orthopaedic Associates
Published on BioPortfolio: 2014-07-23T16:09:28-0400
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