Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-05 @ 6:20 PM
Study NCT ID:
NCT02362867
Status:
COMPLETED
Last Update Posted:
2021-09-24
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balanced Knee System Clinical Protocol for IRB Approval
Sponsor:
Ortho Development Corporation
Organization:
Study Overview
Official Title:
Balanced Knee System Clinical Protocol for IRB Approval
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: