Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus

Not Applicable

Suspended

• Conditions: Knee Injuries
• Interventions: Device: dCELL® Meniscus

• Registration Number: NCT02270905
• Lead Sponsor: Tissue Regenix Ltd

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-17
• Study First Posted: 2014-10-21
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-19
• Last Update Posted: 2018-11-20
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dCELL® Meniscus	dCELL® Meniscus	-

Primary Outcome Measures

Name	Time	Method
Pain relief as assessed by Visual Analog Scale (VAS)	24 months	Change in VAS Pain score from baseline

Secondary Outcome Measures

Name	Time	Method
Knee functional improvement as assessed by patient questionnaires	24 months	IKDC, Lysholm and KOOS score change over time

Trial Locations

Locations (4)

The Hillingdon Hospitals NHS FOUNDATION TRUST; 🇬🇧 Uxbridge, United Kingdom

Clifton Park Hospital; 🇬🇧 York, United Kingdom

The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS FOUNDATION TRUST; 🇬🇧 Oswestry, Shropshire, United Kingdom

"Ortotrauma" Spółka Z Ograniczoną; 🇵🇱 Bialystok, Poland