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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02540811
Recruitment Status : Active, not recruiting
First Posted : September 4, 2015
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Knee Injuries Device: dCELL® ACL Scaffold Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® ACL Scaffold) for Reconstruction of the Anterior Cruciate Ligament
Study Start Date : September 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dCELL® ACL Scaffold Device: dCELL® ACL Scaffold



Primary Outcome Measures :
  1. Arthrometric measurement of knee joint laxity [ Time Frame: 24 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

  2. Number of Participants With Treatment-Related Adverse Events [ Time Frame: 24 months ]
    The frequency and seriousness of any adverse events or adverse device effects will be assessed


Secondary Outcome Measures :
  1. Outcome measure questionnaire of knee functional improvement in terms of symptoms, sport activities and ability to function [ Time Frame: 24 months ]
    Patient's subjective score of 1 to 100 points, with 100 implying the best results and 1 the worst results

  2. Evidence of integration of the investigational product by MRI [ Time Frame: 24 months ]
    Changes to the articular cartilage or joint space at follow up time points compared to pre-surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540811


Locations
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Poland
Klinika Chirurgii Endoskopowej Sp. z o.o.
Zory, Ul. Bankowa 2, Poland, 44-240
Med-Polonia Sp. z o.o.
Poznan, Ul. Obornicka 262, Poland, 60-406
Spain
Hospital Infanta Elena de Madrid-Valdemoro
Madrid, Avd. Reyes Catolicos, 21, Spain, 28342
Hospital Clinico San Carlos
Madrid, Calle Profesor Martin Lagos, Spain, 28001
Hospital Universitario La Ribera de Alzira
Valencia, Carretera Corbera, Km1, Spain, 46600
Hospital Universitari de Bellvitage
Barcelona, L'Hospilatet De Llobregat, Spain, 08907
United Kingdom
Clifton Park Hospital
York, North Yorkshire, United Kingdom, YO30 5RA
Robert Jones and Agnes Hunt Hospital NHS Foundation Trust
Oswestry, Shropshire, United Kingdom, SY10 7AG
Sponsors and Collaborators
Tissue Regenix Ltd
Investigators
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Principal Investigator: Simon Roberts The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
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Responsible Party: Tissue Regenix Ltd
ClinicalTrials.gov Identifier: NCT02540811    
Other Study ID Numbers: TRG-A01-01
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries