Acute Knee Cartilage InjuryEAGLENCT02309957
EAGLE European Post Market Study
An observational study of Acute Knee Cartilage Injury and Tear of Articular Cartilage of Knee, Current, run by Kensey Nash Corporation at 6 sites in 4 countries.
Trial summary
Prospective, multi-center, non-randomized, historical controlled, post-market study of patients requiring surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Knee Cartilage Injury, Tear of Articular Cartilage of Knee, Current
- What is being tested?
- BioMatrix CRD
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 6 sitesin 4 countries
- Study dates
- May 2011to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Observational study of patients receiving BioMatrix CRD for surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany3 sites
University of Schleswig-Holstein, Campus Lübeck
Lübeck
Technische Universität München
München
Klinikum der Universität Regensburg
Regensburg
United Kingdom1 site
Robert Jones & Agnes Hunt Orthopaedic Hospital
Oswestry
About this study
Official title: Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions ("EAGLE") European Post Market Study
Prospective, multi-center, non-randomized, historical controlled, post-market study of patients requiring surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee.
Read the detailed description
BioMatrix CRD is a CE marked device that is intended to repair focal articular cartilage lesions or osteochondral defects in the knee. BioMatrix CRD™ is a sterile, biphasic, bioresorbable scaffold designed to aid in the repair of cartilage and subchondral bone. The device serves as a scaffold for cellular and extracellular matrix ingrowth supporting the regeneration of cartilage and subchondral bone.
The purpose of this post-market study is to confirm the safety and performance of the BioMatrix CRD for its intended use. Fifty (50) patients will be enrolled at up to 10 hospitals in Europe. Patients will be followed for 2 years post-operative to examine the rate of adverse events associated with the device, track improvement in knee pain and knee function over time, and assess the quality of repair tissue.
- Being tested
- BioMatrix CRD
- Keywords
- Knee Cartilage Repair, Osteochondral Defects, BioMatrix CRD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioMatrix CRDDevice
| Study group | Role | What they receive |
|---|---|---|
| BioMatrix CRD | All patients will receive BioMatrix CRD to repair an articular cartilage lesion or osteochondral defect. Receives: Device: BioMatrix CRD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Implant Failure
Rate of implant failure resulting in device removal and/or further surgical intervention due to a device related complication
Measured: 24 months
Secondary outcomes (3)
Knee Related Adverse Events
Measured: 24 months
Quality of repair tissue as assessed by magnetic resonance imaging
Measured: at 24 months
Improvement in knee pain and function as reported by patients on the Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startMay 2011
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Knee Cartilage InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kensey Nash Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Justus Gille, PD Dr med, Principal investigator, University Hopsital Schleswig Holstein Campus Lübeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309957
- Sponsor's protocol ID
- EAGLE EU Post Market Study
- Acronym
- EAGLE
- Status last verified
- Aug 2019
- First submitted
- 2 Dec 2014
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions ("EAGLE") European Post Market Study
- ClinicalTrials.gov ID
- NCT02309957
- Acronym / sponsor ID
- EAGLE / EAGLE EU Post Market Study
- Keywords
- Knee Cartilage Repair, Osteochondral Defects, BioMatrix CRD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Kensey Nash CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, non-randomized, historical controlled, post-market study of patients requiring surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee.
Detailed description
BioMatrix CRD is a CE marked device that is intended to repair focal articular cartilage lesions or osteochondral defects in the knee. BioMatrix CRD™ is a sterile, biphasic, bioresorbable scaffold designed to aid in the repair of cartilage and subchondral bone. The device serves as a scaffold for cellular and extracellular matrix ingrowth supporting the regeneration of cartilage and subchondral bone.
The purpose of this post-market study is to confirm the safety and performance of the BioMatrix CRD for its intended use. Fifty (50) patients will be enrolled at up to 10 hospitals in Europe. Patients will be followed for 2 years post-operative to examine the rate of adverse events associated with the device, track improvement in knee pain and knee function over time, and assess the quality of repair tissue.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioMatrix CRD | – | Device: BioMatrix CRDAll patients will receive BioMatrix CRD to repair an articular cartilage lesion or osteochondral defect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Observational study of patients receiving BioMatrix CRD for surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioMatrix CRD | Device | BioMatrix CRD |
Primary outcome
Rate of Implant Failure
Time frame: 24 months
Rate of implant failure resulting in device removal and/or further surgical intervention due to a device related complication
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justus Gille, PD Dr med principal investigator
University Hopsital Schleswig Holstein Campus Lübeck
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Knee Cartilage Injury and Tear of Articular Cartilage of Knee, Current, run by Kensey Nash Corporation at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Italy, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Implant Failure (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.