The primary purpose of this investigation is to evaluate the surgical performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a Multi-centre setting. The secondary objective of this investigation is to evaluate the long-term survivorship of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee.
Primary endpoint - to demonstrate the suitability of the developed instrumentation to safely and accurately implant the preservation Unicompartmental Knee using postoperative radiographic limb and component alignment data. Secondary endpoints - to demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiological assessment, Oxford Knee Score and survivorship analysis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
247
Minimally invasive orthopaedic implant for single compartment knee arthritis
Sportsmed SA, 32 Payneham, Stepney
Adelaide, South Australia, Australia
To demonstrate the suitability of the developed instrumentation to safely and accurately implant the Preservation Unicompartmental Knee using radiographic and intra-operative assessment
Intraoperative
Time frame: 0 days
To demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiographic assessment, Oxford Knee Score and survivorship analysis.
Time frame: 6 months, 1, 3, 5, 10 and 15 years
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