Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament

Knee Injuries Clinical Trial

Official title:

A Prospective, Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® ACL Scaffold) for Reconstruction of the Anterior Cruciate Ligament

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540811
• Other study ID #: TRG-A01-01
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: August 11, 2021

Study information

• Verified date: November 2022
• Source: Tissue Regenix Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 11, 2021
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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/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.

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Device:
• dCELL® ACL Scaffold

Locations

Country	Name	City	State
Poland	Med-Polonia Sp. z o.o.	Poznan	Ul. Obornicka 262
Poland	Klinika Chirurgii Endoskopowej Sp. z o.o.	Zory	Ul. Bankowa 2
Spain	Hospital Universitari de Bellvitage	Barcelona	L'Hospilatet De Llobregat
Spain	Hospital Clinico San Carlos	Madrid	Calle Profesor Martin Lagos
Spain	Hospital Infanta Elena de Madrid-Valdemoro	Madrid	Avd. Reyes Catolicos, 21
Spain	Hospital Universitario La Ribera de Alzira	Valencia	Carretera Corbera, Km1
United Kingdom	Robert Jones and Agnes Hunt Hospital NHS Foundation Trust	Oswestry	Shropshire
United Kingdom	Clifton Park Hospital	York	North Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Tissue Regenix Ltd

Countries where clinical trial is conducted

Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Primary	Lachman Test	Clinical assessment of knee stability	Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Primary	Pivot Shift Test	Clinical assessment of knee stability	Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Primary	Number of Participants With Treatment-Related Adverse Events	The frequency and seriousness of any adverse events or adverse device effects will be assessed	Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	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	Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	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	Baseline, 3 months, 6 months, 12 months, 24 months