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

Primary Purpose

Knee Injuries

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
dCELL® ACL Scaffold
Sponsored by
Tissue Regenix Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Klinika Chirurgii Endoskopowej Sp. z o.o.
  • Med-Polonia Sp. z o.o.
  • Hospital Infanta Elena de Madrid-Valdemoro
  • Hospital Clinico San Carlos
  • Hospital Universitario La Ribera de Alzira
  • Hospital Universitari de Bellvitage
  • Clifton Park Hospital
  • Robert Jones and Agnes Hunt Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dCELL® ACL Scaffold

Arm Description

Outcomes

Primary Outcome Measures

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
Lachman Test
Clinical assessment of knee stability
Pivot Shift Test
Clinical assessment of knee stability
Number of Participants With Treatment-Related Adverse Events
The frequency and seriousness of any adverse events or adverse device effects will be assessed

Secondary Outcome Measures

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
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

Full Information

First Posted
August 26, 2015
Last Updated
November 24, 2022
Sponsor
Tissue Regenix Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02540811
Brief Title
Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament
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 Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 11, 2021 (Actual)
Study Completion Date
August 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tissue Regenix Ltd

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dCELL® ACL Scaffold
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
dCELL® ACL Scaffold
Primary Outcome Measure Information:
Title
Arthrometric measurement of knee joint laxity
Description
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
Time Frame
Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Title
Lachman Test
Description
Clinical assessment of knee stability
Time Frame
Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Title
Pivot Shift Test
Description
Clinical assessment of knee stability
Time Frame
Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Title
Number of Participants With Treatment-Related Adverse Events
Description
The frequency and seriousness of any adverse events or adverse device effects will be assessed
Time Frame
Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary Outcome Measure Information:
Title
Outcome measure questionnaire of knee functional improvement in terms of symptoms, sport activities and ability to function
Description
Patient's subjective score of 1 to 100 points, with 100 implying the best results and 1 the worst results
Time Frame
Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Title
Evidence of integration of the investigational product by MRI
Description
Changes to the articular cartilage or joint space at follow up time points compared to pre-surgery
Time Frame
Baseline, 3 months, 6 months, 12 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Roberts
Organizational Affiliation
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinika Chirurgii Endoskopowej Sp. z o.o.
City
Zory
State/Province
Ul. Bankowa 2
ZIP/Postal Code
44-240
Country
Poland
Facility Name
Med-Polonia Sp. z o.o.
City
Poznan
State/Province
Ul. Obornicka 262
ZIP/Postal Code
60-406
Country
Poland
Facility Name
Hospital Infanta Elena de Madrid-Valdemoro
City
Madrid
State/Province
Avd. Reyes Catolicos, 21
ZIP/Postal Code
28342
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
State/Province
Calle Profesor Martin Lagos
ZIP/Postal Code
28001
Country
Spain
Facility Name
Hospital Universitario La Ribera de Alzira
City
Valencia
State/Province
Carretera Corbera, Km1
ZIP/Postal Code
46600
Country
Spain
Facility Name
Hospital Universitari de Bellvitage
City
Barcelona
State/Province
L'Hospilatet De Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Clifton Park Hospital
City
York
State/Province
North Yorkshire
ZIP/Postal Code
YO30 5RA
Country
United Kingdom
Facility Name
Robert Jones and Agnes Hunt Hospital NHS Foundation Trust
City
Oswestry
State/Province
Shropshire
ZIP/Postal Code
SY10 7AG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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