NCT04537013

Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee

A ProSpective, MulticEnter, Concurrently Controlled Clinical Study of Chondro-Gide® ArticUlar Cartilage CoveR for the Treatment of Large Chondral Lesions in the KnEe (SECURE)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Geistlich Pharma AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.

Detailed description

The study evaluates the investigational treatment for treating large chondral lesions of the knee to the control treatment of microfracture alone for treating small lesions.Eligible patients with a large lesion will be treated with microfracture plus the Chondro-Gide® ACC and compared to patients with small lesions that are treated with microfracture alone. Outcome measures to be assessed include patient reported outcomes and freedom from certain adverse events.

Conditions

• Knee Injuries
• Cartilage Injury
• Cartilage Disease
• Knee Discomfort

Interventions

Type	Name	Description
PROCEDURE	Microfracture	Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells.
DEVICE	Microfracture plus placement of Chondro-Gide® ACC	Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells, followed by affixing Chondro-Gide® with fibrin glue.

Timeline

• Start date: 2020-08-26
• Primary completion: 2025-09-25
• Completion: 2025-09-29
• First posted: 2020-09-03
• Last updated: 2026-02-13

Locations

15 sites across 3 countries: United States, Canada, Germany

Regulatory

• FDA-regulated device study