Research
Episealer® Knee System IDE Clinical Study
Dealing with a knee injury is no walk in the park.
EPIC-Knee: Episealer® Knee System IDE Clinical Study is a prospective, randomised, controlled, multi-centre 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.
The study is performed at hospitals in the US and Europe and 180 total subjects are randomised at a 2:1 ratio to either the Episealer group (n=120) or the control group (n=60). All patients will be followed over a period of 2 years. The study is intended for patients in the age group 30-70 years with one single chondral or osteochondral lesion in the femoral knee joint.
More details about the EPIC-Knee study, as well as an overview of participating hospitals, can be found at ClinicalTrials.gov (ID: NCT04000659).
To see if you qualify, talk to Dr. Eifler today!
FDA TRIALS
MPA-CARTISTEM-2023-01, Phase 3 FDA Clinical Trial:
Randomized, Prospective, Double Blinded, Multi-Center, Phase 3 Pivotal Clinical Trial to Compare Efficacy and Safety of CARTISTEM and Surgical Comparator in Participants in Knee Osteoarthritis and Cartilage Lesions. TBD/January 2026.
FastTRACK, Hyalofast 15-01, Phase 3 FDA Clinical Trial:
A Prospective, Randomized, Active Treatment-controlled, Evaluator-blinded Multicenter Study to
Establish the Superiority of a Hyaluronan-based Scaffold (Hyalofast) with Autologous Bone Marrow Aspirate Concentrate (BMAC) in the Treatment of Articular Cartilage Defect Lesions in Comparison to Control (Microfracture).
August 2017 – May 2025. Completed.
EPIC-Knee Episealer Knee System IDE, Phase 3 FDA Clinical Trial:
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.
May 2020 – current.
RECRO, Phase 3B FDA Clinical Trial:
Randomized, Double-Blind, Placebo-Control, Multicenter, Evaluation of the Safety and Efficacy of N1539 Administered Preoperatively in Unilateral Total Knee Arthroplasty. 2018-2019. Completed.
CINGAL, Phase 3 FDA Clinical Trial:
A Prospective Randomized, Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee. Completed.
Quest IDE Study, Phase 3 FDA Clinical Trial:
High Frequency Nerve Block for Post-Amputation Pain, NCT 02221934. Completed.
