Status:
SUSPENDED
Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus
Lead Sponsor:
Tissue Regenix Ltd
Conditions:
Knee Injuries
Eligibility:
All Genders
18-50 years
Phase:
NA
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 ce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02270905
Start Date
October 1 2014
End Date
December 1 2018
Last Update
November 20 2018
Active Locations (4)
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1
"Ortotrauma" Spółka Z Ograniczoną
Bialystok, Poland
2
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS FOUNDATION TRUST
Oswestry, Shropshire, United Kingdom
3
The Hillingdon Hospitals NHS FOUNDATION TRUST
Uxbridge, United Kingdom
4
Clifton Park Hospital
York, United Kingdom