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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 7, 2021
Sponsor:
Information provided by (Responsible Party):
Tissue Regenix Ltd

Tracking Information
First Submitted Date  ICMJE August 26, 2015
First Posted Date  ICMJE September 4, 2015
Last Update Posted Date October 7, 2021
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2015)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2015)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament
Official Title  ICMJE A Prospective, Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® ACL Scaffold) for Reconstruction of the Anterior Cruciate Ligament
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Injuries
Intervention  ICMJE Device: dCELL® ACL Scaffold
Study Arms  ICMJE Experimental: dCELL® ACL Scaffold
Intervention: Device: dCELL® ACL Scaffold
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 3, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02540811
Other Study ID Numbers  ICMJE TRG-A01-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tissue Regenix Ltd
Study Sponsor  ICMJE Tissue Regenix Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Simon Roberts The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
PRS Account Tissue Regenix Ltd
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP