dCELL® ACL Scaffold
Research type
Research Study
Full title
A Prospective, Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® ACL Scaffold) for Reconstruction of the Anterior Cruciate Ligament.
IRAS ID
173028
Contact name
Neil Hunt
Contact email
Sponsor organisation
TRx Orthopaedics Ltd.
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Summary of Research
This is a prospective, non-comparative clinical investigation of a novel decellularised porcine xenograft (dCELL® ACL Scaffold). The dCELL® ACL Scaffold is a porcine derived, acellular biological scaffold developed using Tissue Regenix Group’s dCELL® platform technology. It is indicated for use in patients who require reconstruction of primary ruptured anterior cruciate ligament of the knee. A total of 40 subjects will be enrolled in up to 8 sites in the United Kingdom, Germany and Spain. Patients must be male or female patients between 18 and 60 years old, who have a partial or complete tear of the ACL and require reconstruction of the ACL. The primary objectives of this study are to assess the performance of dCELL® ACL Scaffold in its intended use in patients with a ruptured ACL, and the safety of the device by evaluating the nature and incidence of adverse events and the need for surgical re-intervention to the treated knee. Total duration of the study is 30 months, 6 months enrolment and a follow-up phase of 24 months.
Summary of Results
OrthoPure XT Study Results Summary:
This clinical investigation was performed to assess clinical safety and performance of the OrthoPure XT device, previously referenced as dCELL® ACL Scaffold, when used for primary anterior cruciate ligament reconstruction.
The study consisted of the 24-month follow-up period designed for pre-market data collection and the follow-up period from 24 up to 60 months designed for long-term data collection, both periods are completed.
A total of 40 patients were included and treated with the device in the study. Out of 40 patients, 33 patients completed the 24-month follow-up, and 19 patients completed the 60-month follow-up.
SAFETY: All safety events recorded in the study were reviewed. The pattern of those safety events was similar to the events observed after anterior cruciate ligament reconstruction with other treatment options used for this indication. A review of the safety data related to the device and safety data related to procedure showed that there was no unusual, or specific reaction caused by the OrthoPure XT device. The most commonly reported safety events were joint pain and fever.
PERFORMANCE: Based on the performance data for the full study population, stability of knee implanted with OrthoPure XT device was improved. Patients implanted with the device also showed significant improvement of knee functions compared with the knee condition before surgery.
SUMMARY: Overall, the 24-month clinical safety and performance data of the OrthoPure XT device met the study expectations. The results are in line with expectations following primary anterior cruciate ligament reconstruction using the current standard of care. Study outcomes demonstrated that the device is safe and performs as intended. The data analysis at 60-month follow-up has supported the conclusion that primary ACL reconstruction with the OrthoPure XT device is successful. No new or unexpected risks have been identified following long-term use of the device.
Further details of the study will be posted on the ClinicalTrials.gov website, study number: NCT02540811.
A future post-market clinical follow-up study with OrthoPure XT will focus on the treatment of patients with multi-ligament injured knees. The purpose of this study will be to monitor any remaining risks in the current phase (device on the market) and to collect additional data on safety and performance of the device when used during multi-ligament knee reconstruction.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0101
Date of REC Opinion
23 Apr 2015
REC opinion
Further Information Favourable Opinion