Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus
An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus
1 other identifier
interventional
32
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 17, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 20, 2018
November 1, 2018
4.2 years
October 17, 2014
November 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain relief as assessed by Visual Analog Scale (VAS)
Change in VAS Pain score from baseline
24 months
Secondary Outcomes (1)
Knee functional improvement as assessed by patient questionnaires
24 months
Study Arms (1)
dCELL® Meniscus
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
"Ortotrauma" Spółka Z Ograniczoną
Bialystok, Poland
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS FOUNDATION TRUST
Oswestry, Shropshire, United Kingdom
The Hillingdon Hospitals NHS FOUNDATION TRUST
Uxbridge, United Kingdom
Clifton Park Hospital
York, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Houlihan-Burne
The Hillingdon Hospitals NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2014
First Posted
October 21, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
November 20, 2018
Record last verified: 2018-11