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

November 24, 2022 updated by: Tissue Regenix Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Ul. Bankowa 2
      • Zory, Ul. Bankowa 2, Poland, 44-240
        • Klinika Chirurgii Endoskopowej Sp. z o.o.
    • Ul. Obornicka 262
      • Poznan, Ul. Obornicka 262, Poland, 60-406
        • Med-Polonia Sp. z o.o.
  • Spain
    • Avd. Reyes Catolicos, 21
      • Madrid, Avd. Reyes Catolicos, 21, Spain, 28342
        • Hospital Infanta Elena de Madrid-Valdemoro
    • Calle Profesor Martin Lagos
      • Madrid, Calle Profesor Martin Lagos, Spain, 28001
        • Hospital Clinico San Carlos
    • Carretera Corbera, Km1
      • Valencia, Carretera Corbera, Km1, Spain, 46600
        • Hospital Universitario La Ribera de Alzira
    • L'Hospilatet De Llobregat
      • Barcelona, L'Hospilatet De Llobregat, Spain, 08907
        • Hospital Universitari de Bellvitage
  • United Kingdom
    • North Yorkshire
      • York, North Yorkshire, United Kingdom, YO30 5RA
        • Clifton Park Hospital
    • Shropshire
      • Oswestry, Shropshire, United Kingdom, SY10 7AG
        • Robert Jones and Agnes Hunt Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dCELL® ACL Scaffold
Device: dCELL® ACL Scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arthrometric measurement of knee joint laxity
Time Frame: 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
Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Lachman Test
Time Frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Clinical assessment of knee stability
Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Pivot Shift Test
Time Frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Clinical assessment of knee stability
Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Number of Participants With Treatment-Related Adverse Events
Time Frame: 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
Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome measure questionnaire of knee functional improvement in terms of symptoms, sport activities and ability to function
Time Frame: 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
Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Evidence of integration of the investigational product by MRI
Time Frame: 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
Baseline, 3 months, 6 months, 12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tissue Regenix Ltd

Investigators

  • Principal Investigator: Simon Roberts, The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

August 11, 2021

Study Completion (Actual)

August 11, 2021

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 24, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRG-A01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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