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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
500
A multi-compartmental total knee replacement providing a system of components for primary posterior cruciate ligament substituting procedures. The system consists of femoral, tibial, and patellar components that allow the surgeon to select the most appropriate component combination to meet specific patient needs.
Evaluate effectiveness of the BKS by assessing complications during surgery and the post-operative follow-up period
Time frame: 1-10 years
Assess the effectiveness of the BKS by analyzing radiographic evidence and clinical data.
Time frame: 1-10 years
Identify any surveillance issues regarding the device design and surgical approach used refinement of the surgical technique
Time frame: 1-10 years
Evaluate device performance through the use of the Knee Society Score, Short Form-36 Health Survey, and radiographic evaluation.
Time frame: 1-10 years
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