|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02309957 |
|
Date of registration:
|
02/12/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
EAGLE European Post Market Study
EAGLE |
|
Scientific title:
|
Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions ("EAGLE") European Post Market Study |
|
Date of first enrolment:
|
May 2011 |
|
Target sample size:
|
33 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02309957 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Germany
|
Italy
|
Netherlands
|
United Kingdom
| | | | |
|
Contacts
|
|
Name:
|
Justus Gille, PD Dr med |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Schleswig-Holstein, Campus Lübeck |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Pre-procedure KOOS Pain subscale score less than or equal to 70.
- ICRS grade 3 or 4 focal articular cartilage lesion on the medial femoral condyle,
lateral femoral condyle or trochlea, which measures less than or equal to15mm in
diameter.
- Cartilage lesion is amenable to treatment with a single BioMatrix CRD or an
osteochondral autograft.
Exclusion Criteria:
- Previous cartilage repair procedure (i.e., microfracture, OATS, ACI) at the intended
implantation site.
- Clinically significant (> 5 degrees) varus or valgus malalignment in either knee.
- Osteoarthritis in the injured knee.
- Inflammatory arthropathy
- Osteomyelitis or other active infection in either lower limb.
- Cortisone or hyaluronic acid knee injections in the past 3 months
- Body mass index greater than 35.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Acute Knee Cartilage Injury
|
|
Tear of Articular Cartilage of Knee, Current
|
|
Intervention(s)
|
|
Device: BioMatrix CRD
|
|
Primary Outcome(s)
|
|
Rate of Implant Failure
[Time Frame: 24 months]
|
|
Secondary Outcome(s)
|
|
Knee Related Adverse Events
[Time Frame: 24 months]
|
|
Quality of repair tissue as assessed by magnetic resonance imaging
[Time Frame: at 24 months]
|
|
Improvement in knee pain and function as reported by patients on the Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire
[Time Frame: 24 months]
|
|
Secondary ID(s)
|
|
EAGLE EU Post Market Study
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|