Balanced Knee System Clinical Protocol for IRB Approval

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Osteoarthritis
Osteoarthritis, Knee
Post-traumatic Osteoarthritis of Knee Nos
Rheumatoid Arthritis of Knee
Valgus Deformity

Clinical Trial Details

NCT number	NCT02362867
Study type	Interventional
Source	Ortho Development Corporation
Contact
Status	Completed
Phase	N/A
Start date	January 2003
Completion date	June 2, 2019

View Details

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