Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament
- Conditions
- Knee Injuries
- Interventions
- Device: dCELL® ACL Scaffold
- Registration Number
- NCT02540811
- Lead Sponsor
- Tissue Regenix Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dCELL® ACL Scaffold dCELL® ACL Scaffold -
- Primary Outcome Measures
Name Time Method Arthrometric measurement of knee joint laxity 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 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 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 Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months Clinical assessment of knee stability
- Secondary Outcome Measures
Name Time Method Evidence of integration of the investigational product by MRI Baseline, 3 months, 6 months, 12 months, 24 months Changes to the articular cartilage or joint space at follow up time points compared to pre-surgery
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 Patient's subjective score of 1 to 100 points, with 100 implying the best results and 1 the worst results
Trial Locations
- Locations (8)
Robert Jones and Agnes Hunt Hospital NHS Foundation Trust
🇬🇧Oswestry, Shropshire, United Kingdom
Clifton Park Hospital
🇬🇧York, North Yorkshire, United Kingdom
Hospital Infanta Elena de Madrid-Valdemoro
🇪🇸Madrid, Avd. Reyes Catolicos, 21, Spain
Hospital Universitari de Bellvitage
🇪🇸Barcelona, L'Hospilatet De Llobregat, Spain
Hospital Universitario La Ribera de Alzira
🇪🇸Valencia, Carretera Corbera, Km1, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Calle Profesor Martin Lagos, Spain
Klinika Chirurgii Endoskopowej Sp. z o.o.
🇵🇱Zory, Ul. Bankowa 2, Poland
Med-Polonia Sp. z o.o.
🇵🇱Poznan, Ul. Obornicka 262, Poland