NCT04000659

Episealer® Knee System IDE Clinical Study

A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Episealer® Knee System Compared to Microfracture for the Treatment of Focal Femoral Knee Chondral or Osteochondral Lesions

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Episurf Medical Inc. · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is a randomized, prospective, multicenter, controlled clinical trial of the Episealer Knee System. The Episealer Knee System is intended for subjects with up to two focal femoral knee chondral or osteochondral lesion that is causing pain and/or disability and requires surgical treatment.

Detailed description

The primary objective of this study is to evaluate the safety and clinical effectiveness of the Episealer Knee System (Episealer Trochlea Solo, Episealer Femoral Twin, and Episealer Condyle Solo) compared to microfracture (with or without debridement) in a group of subjects that require repair of up to 2 focal femoral chondral or osteochondral lesions in the knee. Clinical success will be analyzed via subject reported outcomes to measure function and pain improvements as compared to baseline, incidence of secondary surgical interventions for the treated knee, absence of subsidence or migration through radiographic assessment, and assessment of weight-bearing status.

Conditions

• Degenerative Lesion of Articular Cartilage of Knee

Interventions

Type	Name	Description
DEVICE	Episealer Knee System	The Episealer Knee System is comprised of individualized endoprosthetic resurfacing implants and implantation tools (Episealer Toolkit). The implants are designed to replace the articulating surface which has been damaged due to femoral knee chondral and osteochondral defects.
PROCEDURE	Microfracture	Microfracture is a minimally invasive surgical technique developed to repair defects in articular cartilage and reduce pain in the knee joint. Microfracture techniques are described in the orthopedic literature and are performed arthroscopically.

Timeline

• Start date: 2020-06-18
• Primary completion: 2026-06-01
• Completion: 2028-06-01
• First posted: 2019-06-27
• Last updated: 2024-07-30

Locations

13 sites across 4 countries: United States, Canada, Germany, United Kingdom

Regulatory

• FDA-regulated device study