Clincosm LogoSign in Get a demo

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

Sponsor
Tissue Regenix Ltd (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02540811
Collaborator
(none)
40
Enrollment
8
Locations
1
Arm
75
Duration (Months)
5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: dCELL® ACL Scaffold
 N/A

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 Design

Study Type:
Interventional
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 :
Sep 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: dCELL® ACL Scaffold

Device: dCELL® ACL Scaffold

Outcome Measures

Primary Outcome Measures

  1. Arthrometric measurement of knee joint laxity [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 [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 [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 [24 months]

    Changes to the articular cartilage or joint space at follow up time points compared to pre-surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Tissue Regenix Ltd

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tissue Regenix Ltd
ClinicalTrials.gov Identifier:
NCT02540811
Other Study ID Numbers:
  • TRG-A01-01
First Posted:
Sep 4, 2015
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Additional relevant MeSH terms:
Knee Injuries

Study Results

No Results Posted as of Oct 7, 2021