A Prospective, Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® ACL Scaffold) for Reconstruction of the Anterior Cruciate Ligament
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Injuries
- Sponsor
- Tissue Regenix Ltd
- Enrollment
- 40
- Locations
- 8
- Primary Endpoint
- Arthrometric measurement of knee joint laxity
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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/m
- •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.
Outcomes
Primary Outcomes
Arthrometric measurement of knee joint laxity
Time Frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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
Lachman Test
Time Frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Clinical assessment of knee stability
Number of Participants With Treatment-Related Adverse Events
Time Frame: Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
The frequency and seriousness of any adverse events or adverse device effects will be assessed
Pivot Shift Test
Time Frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Clinical assessment of knee stability
Secondary Outcomes
- Evidence of integration of the investigational product by MRI(Baseline, 3 months, 6 months, 12 months, 24 months)
- Outcome measure questionnaire of knee functional improvement in terms of symptoms, sport activities and ability to function(Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)