NCT06670651

LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: LinkBio Corp. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis (OA) of the Knee
• Fracture
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	total knee arthroplasty device	total knee arthroplasty device with ultracongruent bearing surface

Timeline

• Start date: 2025-03-21
• Primary completion: 2031-12-01
• Completion: 2031-12-01
• First posted: 2024-11-01
• Last updated: 2025-06-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study