An interventional study of dCELL® ACL Scaffold in Knee Injuries, sponsored by Tissue Regenix Ltd. Completed at 8 sites in 3 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by Tissue Regenix Ltd · Not applicable, Interventional, and Treatment
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.
249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 160 interventional studies indexed under Knee Injuries.
Browse Knee Injuries studies →Tissue Regenix Ltd is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: dCELL® ACL Scaffold
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
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Lachman Test
Clinical assessment of knee stability
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Pivot Shift Test
Clinical assessment of knee stability
Time frame: 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
Time frame: Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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
Time frame: 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
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Tissue Regenix Ltd