Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus
Primary Purpose
Knee Injuries
Status
Suspended
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
dCELL® Meniscus
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injuries focused on measuring meniscus, meniscectomy, decellularised, xenograft
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with chronic pain following failed previous meniscus repair or partial meniscectomy
- Must be a stable, well aligned knee with ligament laxity of Grade II or less
- Osteoarthritis <grade 3 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
- Patients with a current ligament injury requiring immediate surgery or have had ligament surgery in the previous three months
- Patients using anticoagulants
- Patients on current immuno-suppressive or radiation therapy or having received such therapies 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
- "Ortotrauma" Spółka Z Ograniczoną
- The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS FOUNDATION TRUST
- The Hillingdon Hospitals NHS FOUNDATION TRUST
- Clifton Park Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dCELL® Meniscus
Arm Description
Outcomes
Primary Outcome Measures
Pain relief as assessed by Visual Analog Scale (VAS)
Change in VAS Pain score from baseline
Secondary Outcome Measures
Knee functional improvement as assessed by patient questionnaires
IKDC, Lysholm and KOOS score change over time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02270905
Brief Title
Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus
Official Title
An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Suspended
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
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® Meniscus will be evaluated in 60 patients after partial replacement of the native medial or lateral meniscus with the investigational product.
Detailed Description
The dCELL® Meniscus is a novel decellularised porcine xenograft which is processed using a patented variation of Tissue Regenix's platform dCELL® technology to render it biocompatible and free from cellular material, leaving behind an acellular biological scaffold that is safe for human implantation whilst preserving the biomechanical properties. It is indicated as a biological implant to replace parts of the native meniscus in the knee for patients who present with chronic pain following failed previous meniscus repair or partial meniscectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
meniscus, meniscectomy, decellularised, xenograft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dCELL® Meniscus
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
dCELL® Meniscus
Intervention Description
decellularised porcine xenograft
Primary Outcome Measure Information:
Title
Pain relief as assessed by Visual Analog Scale (VAS)
Description
Change in VAS Pain score from baseline
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Knee functional improvement as assessed by patient questionnaires
Description
IKDC, Lysholm and KOOS score change over time
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with chronic pain following failed previous meniscus repair or partial meniscectomy
Must be a stable, well aligned knee with ligament laxity of Grade II or less
Osteoarthritis <grade 3 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
Patients with a current ligament injury requiring immediate surgery or have had ligament surgery in the previous three months
Patients using anticoagulants
Patients on current immuno-suppressive or radiation therapy or having received such therapies 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
David Houlihan-Burne
Organizational Affiliation
The Hillingdon Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Ortotrauma" Spółka Z Ograniczoną
City
Bialystok
Country
Poland
Facility Name
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS FOUNDATION TRUST
City
Oswestry
State/Province
Shropshire
Country
United Kingdom
Facility Name
The Hillingdon Hospitals NHS FOUNDATION TRUST
City
Uxbridge
Country
United Kingdom
Facility Name
Clifton Park Hospital
City
York
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus
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