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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Knee Injuries

Intervention / Treatment
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* Device: dCELL® ACL Scaffold


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dCELL® ACL Scaffold<br> | Device: dCELL® ACL Scaffold<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthrometric measurement of knee joint laxity | Comparison of the magnitude of side-to-side differences in mm between the treated knee and the opposite normal knee using an arthrometric ligament testing device | Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months | 
| Lachman Test | Clinical assessment of knee stability | Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months | 
| Pivot Shift Test | Clinical assessment of knee stability | Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months | 
| Number of Participants With Treatment-Related Adverse Events | The frequency and seriousness of any adverse events or adverse device effects will be assessed | Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome measure questionnaire of knee functional improvement in terms of symptoms, sport activities and ability to function | Patient's subjective score of 1 to 100 points, with 100 implying the best results and 1 the worst results | Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months | 
| Evidence of integration of the investigational product by MRI | Changes to the articular cartilage or joint space at follow up time points compared to pre-surgery | Baseline, 3 months, 6 months, 12 months, 24 months |