Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament

A Prospective, Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® ACL Scaffold) for Reconstruction of the Anterior Cruciate Ligament

The safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have been implanted with the investigational product following a ruptured anterior cruciate ligament (ACL) of the knee.

The dCELL® ACL Scaffold is a novel device manufactured from porcine tissue using a patented variation of Tissue Regenix's platform technology to render the tissue biocompatible and free from cellular material, providing a biological scaffold that is safe for human implantation whilst preserving the biomechanical properties.

The device is used to reconstruct traumatic ACL tears to help restore normal knee function and therefore prevent further wear of the cartilage and future damage.

Inclusion Criteria:

• Patients with partial or complete tear of the ACL and require reconstruction of the ACL.
• Medial Collateral Ligament (MCL) injury grade 2 or less.
• Osteoarthritis grade 2 or less on the Kellgren Lawrence scale.
• Patients who have given written informed consent; and are willing and able to comply with entire study procedures including rehabilitation protocol.

Exclusion Criteria:

• Body Mass Index (BMI) greater than 35 kg/m2.
• Treatment with any investigational drug or device within two months prior to screening.
• Patients presenting with abnormal degenerative osteoarthritis of the joint.
• Previous ACL reconstruction on the target knee.
• Current ACL injury on contralateral knee.
• Patients using anticoagulants within 2 weeks prior to surgery.
• Patients on current immuno-suppressive or radiation therapy within six months of screening.
• Patients with diabetes or cardiovascular disease which precludes elective surgery.
• Patients with documented renal disease or metabolic bone disease.