Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT06670651
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-10
First Post:
2024-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)
Sponsor:
LinkBio Corp.
Organization:
Study Overview
Official Title:
LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-04
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:
To collect information about implant performance and patient clinical outcomes in patients undergoing primary total knee arthroplasty with the LinkSymphoKnee total knee replacement system with ultra-congruent tibial bearing surface.
Detailed Description:
The study will collect outcomes data on up to 600 patients from up to 3 sites using a legally marketed device according to its labeled intended use.
The study will collect:
1. KOOS-JR
2. Knee Society Score (KSS), 2011
3. PROMIS Global Health
4. PROMIS Physical Function
5. PROMIS Pain Interference
6. Surgery Satisfaction
7. Forgotten Joint Score
8. Radiographic findings
9. Revisions.
Radiographic evaluations will be done through postoperative year 2. Other outcomes will be evaluated up to postoperative year 5.
The study will collect:
1. KOOS-JR
2. Knee Society Score (KSS), 2011
3. PROMIS Global Health
4. PROMIS Physical Function
5. PROMIS Pain Interference
6. Surgery Satisfaction
7. Forgotten Joint Score
8. Radiographic findings
9. Revisions.
Radiographic evaluations will be done through postoperative year 2. Other outcomes will be evaluated up to postoperative year 5.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: