NCT03873545

Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Condyle and Patella

A Prospective, Multi-Center Study Evaluating ProChondrix® CR for the Repair of Focal Articular Cartilage Defects in the Knee

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: AlloSource · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to evaluate the use of ProChondrix Cryopreserved Osteochondral Allograft to obtain evidence of effectiveness, defined as an improvement in physical function and pain, when used on a symptomatic cartilage defect on the femoral condyle or patella in a mechanically stable knee.

Detailed description

This clinical study will use a multi-center, prospective design, to evaluate ProChondrix CR in approximately 80 patients who are scheduled to undergo treatment of a cartilage defect on the femoral condyle or patella.Patient follow-up will include a period of 60 months after surgery. During this follow-up period, each patient will be evaluated seven (7) times at: 3, 6, 12, 24, 36, 48 and 60 months after surgical intervention.

Conditions

• Cartilage Injury
• Cartilage Damage

Interventions

Type	Name	Description
PROCEDURE	Cryopreserved Osteochondral Allograft	This tissue is a laser-etched, cryopreserved fresh osteochondral allograft that was developed as a single-stage alternative for articular cartilage restoration.

Timeline

• Start date: 2019-03-18
• Primary completion: 2028-11-01
• Completion: 2028-12-30
• First posted: 2019-03-13
• Last updated: 2025-11-25

Locations

3 sites across 1 country: United States