Articular Cartilage Injury Clinical Trial
Official title:
Initial Safety and Effectiveness Study of the Kensey Nash Corp. Cartilage Repair Device for Knee Cartilage Lesion Repair
The Kensey Nash Corp. Cartilage Repair Device is a bioresorbable scaffold designed to promote repair of knee cartilage and subchondral bone. Subjects with knee cartilage damage meeting eligibility criteria will be randomly assigned to receive treatment with the Cartilage Repair Device or a standard surgical technique called microfracture. The purpose of the study is to evaluate the initial safety and effectiveness of the Cartilage Repair Device compared to microfracture.
Damage to articular cartilage in the knee by acute or chronic injury causes pain and limits
knee function. If left untreated, damage to the articular cartilage can lead to painful
osteoarthritis. The human body has a limited ability to regenerate or adequately repair
damage to articular cartilage. There are several surgical techniques available to assist the
repair of articular cartilage and improve pain and function. Microfracture is the most
commonly used technique for cartilage repair. Microfracture involves the creation of
numerous small fractures in the bone with a pick. These small fractures cause the release of
multipotential stem cells from the bone marrow creating a clot on the surface. Over time,
this clot causes reparative fibrocartilage to form. However, fibrocartilage is less durable
and lacks the mechanical properties of normal articular cartilage. The majority of patients
treated with microfracture has good results within the first 2 years after microfracture.
However, beyond 2 years, functional deterioration is seen in over 50% of patients.
Therefore, there is a clinical need for a product that improves surgical outcomes in
patients with cartilage damage.
The Kensey Nash Corp. Cartilage Repair Device is a two layer, bioresorbable implant. The top
layer consists of collagen fibers like those found in normal cartilage. The collagen layer
is about as thick as the cartilage in human knees. The bottom layer of the Cartilage Repair
Device mainly consists of a calcium mineral naturally found in human bones. The mineral is
held within a biodegradable polymer material. The device has a highly porous structure that
allows the blood, stem cells and joint fluid to infiltrate the device during the healing
process. Over time, the top layer is designed to be replaced by cartilage and the bottom
layer is designed to be replaced by bone.
Both microfracture and the Cartilage Repair Device are expected to reduce knee pain and
increase knee function in a majority of patients during the first 2 years post-operative.
However, if the Cartilage Repair Device produces better and more durable cartilage than the
microfracture technique, those patients treated with the Cartilage Repair Device may have a
better long term outcome.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04463238 -
Guided Cartilage Regeneration Membrane
|
N/A |