Osteoarthritis, Knee Clinical Trial
Official title:
Balanced Knee System Clinical Protocol for IRB Approval
The protocol will define the clinical study for Ortho Development's Balanced Knee® System (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical study will compare the clinical outcomes of BKS to currently marketed devices.
The rationale is based on the potential effectiveness of the BKS to: - Return patient to normal activities or increase mobility by restoring knee function. - Provide stability to enhance rehabilitation without external support. - Eliminate or reduce knee pain. - Assess the clinical efficacy after total knee replacement. - Determine implant survivorship and viability. - Evaluate patient function and satisfaction. ;
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