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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02270905 |
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Date of registration:
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17/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus
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Scientific title:
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An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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32 |
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Recruitment status: |
Suspended |
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URL:
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https://clinicaltrials.gov/show/NCT02270905 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Poland
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United Kingdom
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Contacts
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Name:
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David Houlihan-Burne |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hillingdon Hospitals NHS Foundation Trust |
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Key inclusion & exclusion criteria
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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
- 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
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Knee Injuries
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Intervention(s)
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Device: dCELL® Meniscus
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Primary Outcome(s)
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Pain relief as assessed by Visual Analog Scale (VAS)
[Time Frame: 24 months]
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Secondary Outcome(s)
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Knee functional improvement as assessed by patient questionnaires
[Time Frame: 24 months]
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Secondary ID(s)
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TRG-D02-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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