NCT06627699

Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Maxx Orthopedics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.

Detailed description

In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring. To maintain equal site distribution per device, patient recruitment will include up to a total of twenty (20) registry sites and thirty (30) primary TKA candidates per site / surgeon for a total of 600 registry patients. A total of no more than 200 patients across all sites will be recruited per level of constraint (e.g.: 200 CR, 200:PS, 200:UC) for this registry with a 10-month accrual target from study initiation per site (\~3 patients consented / month).

Conditions

• Knee Osteoarthristis
• Total Knee Anthroplasty

Interventions

Type	Name	Description
DEVICE	Total Knee Arthroplasty	Post-Market Surveillance of the Freedom Total Knee System for Primary TKA

Timeline

• Start date: 2024-11-01
• Primary completion: 2027-11-01
• Completion: 2028-03-01
• First posted: 2024-10-04
• Last updated: 2024-10-04

Locations

2 sites across 1 country: United States