Trials / Completed
CompletedNCT02540811
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Tissue Regenix Ltd · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | dCELL® ACL Scaffold |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2021-08-11
- Completion
- 2021-08-11
- First posted
- 2015-09-04
- Last updated
- 2022-11-30
Locations
8 sites across 3 countries: Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02540811. Inclusion in this directory is not an endorsement.