Articular Cartilage InjuryPhase 2EAGLE PilotNCT01183637
Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions Pilot Trial
A Phase 2 study testing Kensey Nash Corp. Cartilage Repair Device and Microfracture in people with Articular Cartilage Injury, run by Kensey Nash Corporation at 2 sites in United States.
Trial summary
The Kensey Nash Corp. Cartilage Repair Device is a bioresorbable scaffold designed to promote repair of knee cartilage and subchondral bone. Subjects with knee cartilage damage meeting eligibility criteria will be randomly assigned to receive treatment with the Cartilage Repair Device or a standard surgical technique… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Articular Cartilage Injury
- What is being tested?
- Kensey Nash Corp. Cartilage Repair Device and Microfracture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to May 2014
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years old and skeletally mature
- KOOS Pain subscale score is less than 65 (i.e. moderate pain)
- KOOS Activities of Daily Living score is less than 70 (i.e. moderate functional limitations)
- ICRS grade 3 or 4 cartilage lesion on the medial femoral condyle, lateral femoral condyle or trochlea measuring less than or equal to 15mm in diameter
- Stable meniscus with greater than 50% remaining bilaterally
- Mental capacity and willingness to comply with the post-operative rehabilitation plan and follow-up evaluations
- Written informed consent
Who cannot join
- Body mass index greater than 35
- Contraindication for MRI
- Previous microfracture, autograft implantation, allograft implantation or autologous chondrocyte implantation procedure on the damaged cartilage surface
- Knee ligament surgery within the past 6 months
- Clinically significant knee malalignment
- Osteoarthritis in the knee
Show all 13Show fewer
- Multiple cartilage lesions
- Inflammatory arthropathy (i.e. rheumatoid arthritis, systemic lupus or active gout)
- Active infection in either lower limb
- Hyaluronic acid or cortisone injections within the past 3 months
- History of substance abuse
- Current participation in a study of an investigational product for a similar purpose
- Active litigation for the knee injury
Trial locations and contacts
2 sites in 1 country.
United States2 sites
U.S. Center for Sports Medicine
Kirkwood, Missouri, 63122
Peninsula Orthopedic Associates
Salisbury, Maryland, 21804
About this study
Official title: Initial Safety and Effectiveness Study of the Kensey Nash Corp. Cartilage Repair Device for Knee Cartilage Lesion Repair
The Kensey Nash Corp. Cartilage Repair Device is a bioresorbable scaffold designed to promote repair of knee cartilage and subchondral bone. Subjects with knee cartilage damage meeting eligibility criteria will be randomly assigned to receive treatment with the Cartilage Repair Device or a standard surgical technique called microfracture. The purpose of the study is to evaluate the initial safety and effectiveness of the Cartilage Repair Device compared to microfracture.
Read the detailed description
Damage to articular cartilage in the knee by acute or chronic injury causes pain and limits knee function. If left untreated, damage to the articular cartilage can lead to painful osteoarthritis. The human body has a limited ability to regenerate or adequately repair damage to articular cartilage. There are several surgical techniques available to assist the repair of articular cartilage and improve pain and function. Microfracture is the most commonly used technique for cartilage repair. Microfracture involves the creation of numerous small fractures in the bone with a pick. These small fractures cause the release of multipotential stem cells from the bone marrow creating a clot on the surface. Over time, this clot causes reparative fibrocartilage to form. However, fibrocartilage is less durable and lacks the mechanical properties of normal articular cartilage. The majority of patients treated with microfracture has good results within the first 2 years after microfracture. However, beyond 2 years, functional deterioration is seen in over 50% of patients. Therefore, there is a clinical need for a product that improves surgical outcomes in patients with cartilage damage.
The Kensey Nash Corp. Cartilage Repair Device is a two layer, bioresorbable implant. The top layer consists of collagen fibers like those found in normal cartilage. The collagen layer is about as thick as the cartilage in human knees. The bottom layer of the Cartilage Repair Device mainly consists of a calcium mineral naturally found in human bones. The mineral is held within a biodegradable polymer material. The device has a highly porous structure that allows the blood, stem cells and joint fluid to infiltrate the device during the healing process. Over time, the top layer is designed to be replaced by cartilage and the bottom layer is designed to be replaced by bone.
Both microfracture and the Cartilage Repair Device are expected to reduce knee pain and increase knee function in a majority of patients during the first 2 years post-operative. However, if the Cartilage Repair Device produces better and more durable cartilage than the microfracture technique, those patients treated with the Cartilage Repair Device may have a better long term outcome.
- Conditions
- Articular Cartilage Injury
- Being tested
- Kensey Nash Corp. Cartilage Repair Device, Microfracture
- Keywords
- Cartilage, Knee, Osteochondral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kensey Nash Corp. Cartilage Repair DeviceDevice
To perform the Cartilage Repair Device implantation procedure, the surgeon first removes the damaged cartilage. Then, the surgeon creates a cylindrical hole in the bone below the area of damaged cartilage. The Cartilage Repair Device is then implanted into the hole so that the surface is level with the surrounding native cartilage. The Cartilage Repair Device will then absorb blood and bone marrow from the bone to begin the healing process.
MicrofractureProcedure or surgery
To perform the microfracture technique, the surgeon will first remove the damaged cartilage. Then, the surgeon will make a number of small fractures in the bone below the area of damaged cartilage. The fractures cause the bone to bleed and a clot to form over the exposed bone. Over time, the clot forms a layer of fibrocartilage over the bone.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients assigned to the treatment arm will receive treatment with the Kensey Nash Corp. Cartilage Repair Device. Receives: Device: Kensey Nash Corp. Cartilage Repair Device |
| Control | Active comparator | Patients assigned to the Control Arm will receive treatment with the standard surgical technique known as microfracture. Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Success
Improvement in pain, function, and cartilage defect appearance without any treatment related serious adverse events.
Measured: 24 months
Secondary outcomes (3)
Knee Injury and Osteoarthritic Outcome Score ("KOOS")
Clinically significant improvement in the KOOS Pain, Activities of Daily Living, Symptoms, Sports \& Recreation and Quality of Life subscale scores
Measured: 24 months
Cartilage defect appearance on MRI
Cartilage defect filling, repair cartilage integration with surrounding native cartilage and presence of bony overgrowth will be assessed.
Measured: 24 months
Lyshom Score
Clinical significant improvement in the Lysolm Knee Scale score
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 posted17 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2013
- Study completionMay 2014
Why it stopped: Study enrollment rate was far slower than anticipated. Study was stopped for business purposes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kensey Nash Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard C Lehman, M.D., Principal investigator, U.S. Center for Sports Medicine, Kirkwood, MOPhillip A Davidson, M.D., Principal investigator, Heiden - Davidson Orthopedics, Park City, UT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183637
- Sponsor's protocol ID
- EAGLE Pilot
- Acronym
- EAGLE Pilot
- Status last verified
- May 2015
- First submitted
- 28 Jul 2010
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Safety and Effectiveness Study of the Kensey Nash Corp. Cartilage Repair Device for Knee Cartilage Lesion Repair
- ClinicalTrials.gov ID
- NCT01183637
- Acronym / sponsor ID
- EAGLE Pilot / EAGLE Pilot
- Conditions
- Articular Cartilage Injury
- Keywords
- Cartilage, Knee, Osteochondral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study enrollment rate was far slower than anticipated. Study was stopped for business purposes.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Kensey Nash CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Aug 2010 (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.
The Kensey Nash Corp. Cartilage Repair Device is a bioresorbable scaffold designed to promote repair of knee cartilage and subchondral bone. Subjects with knee cartilage damage meeting eligibility criteria will be randomly assigned to receive treatment with the Cartilage Repair Device or a standard surgical technique called microfracture. The purpose of the study is to evaluate the initial safety and effectiveness of the Cartilage Repair Device compared to microfracture.
Detailed description
Damage to articular cartilage in the knee by acute or chronic injury causes pain and limits knee function. If left untreated, damage to the articular cartilage can lead to painful osteoarthritis. The human body has a limited ability to regenerate or adequately repair damage to articular cartilage. There are several surgical techniques available to assist the repair of articular cartilage and improve pain and function. Microfracture is the most commonly used technique for cartilage repair. Microfracture involves the creation of numerous small fractures in the bone with a pick. These small fractures cause the release of multipotential stem cells from the bone marrow creating a clot on the surface. Over time, this clot causes reparative fibrocartilage to form. However, fibrocartilage is less durable and lacks the mechanical properties of normal articular cartilage. The majority of patients treated with microfracture has good results within the first 2 years after microfracture. However, beyond 2 years, functional deterioration is seen in over 50% of patients. Therefore, there is a clinical need for a product that improves surgical outcomes in patients with cartilage damage.
The Kensey Nash Corp. Cartilage Repair Device is a two layer, bioresorbable implant. The top layer consists of collagen fibers like those found in normal cartilage. The collagen layer is about as thick as the cartilage in human knees. The bottom layer of the Cartilage Repair Device mainly consists of a calcium mineral naturally found in human bones. The mineral is held within a biodegradable polymer material. The device has a highly porous structure that allows the blood, stem cells and joint fluid to infiltrate the device during the healing process. Over time, the top layer is designed to be replaced by cartilage and the bottom layer is designed to be replaced by bone.
Both microfracture and the Cartilage Repair Device are expected to reduce knee pain and increase knee function in a majority of patients during the first 2 years post-operative. However, if the Cartilage Repair Device produces better and more durable cartilage than the microfracture technique, those patients treated with the Cartilage Repair Device may have a better long term outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Kensey Nash Corp. Cartilage Repair DevicePatients assigned to the treatment arm will receive treatment with the Kensey Nash Corp. Cartilage Repair Device. |
| Control | Active comparator | Procedure: MicrofracturePatients assigned to the Control Arm will receive treatment with the standard surgical technique known as microfracture. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 21 years old and skeletally mature
- KOOS Pain subscale score is less than 65 (i.e. moderate pain)
- KOOS Activities of Daily Living score is less than 70 (i.e. moderate functional limitations)
- ICRS grade 3 or 4 cartilage lesion on the medial femoral condyle, lateral femoral condyle or trochlea measuring less than or equal to 15mm in diameter
- Stable meniscus with greater than 50% remaining bilaterally
Key exclusion criteria (13 listed)
- Body mass index greater than 35
- Contraindication for MRI
- Previous microfracture, autograft implantation, allograft implantation or autologous chondrocyte implantation procedure on the damaged cartilage surface
- Knee ligament surgery within the past 6 months
- Clinically significant knee malalignment
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 |
|---|---|---|
| Kensey Nash Corp. Cartilage Repair DeviceTo perform the Cartilage Repair Device implantation procedure, the surgeon first removes the damaged cartilage. Then, the surgeon creates a cylindrical hole in the bone below the area of damaged cartilage. The Cartilage Repair Device is then implanted into the hole so that the surface is level with the surrounding native cartilage. The Cartilage Repair Device will then absorb blood and bone marrow from the bone to begin the healing process. | Device | Treatment |
| MicrofractureTo perform the microfracture technique, the surgeon will first remove the damaged cartilage. Then, the surgeon will make a number of small fractures in the bone below the area of damaged cartilage. The fractures cause the bone to bleed and a clot to form over the exposed bone. Over time, the clot forms a layer of fibrocartilage over the bone. | Procedure or surgery | Control |
Primary outcome
Patient Success
Time frame: 24 months
Improvement in pain, function, and cartilage defect appearance without any treatment related serious adverse events.
3 secondary outcomes
Knee Injury and Osteoarthritic Outcome Score ("KOOS")
Time frame: 24 months
Cartilage defect appearance on MRI
Time frame: 24 months
Lyshom Score
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Study enrollment rate was far slower than anticipated. Study was stopped for business purposes.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
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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.
Richard C Lehman, M.D. principal investigator
U.S. Center for Sports Medicine, Kirkwood, MO
Phillip A Davidson, M.D. principal investigator
Heiden - Davidson Orthopedics, Park City, UT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kensey Nash Corp. Cartilage Repair Device and Microfracture in people with Articular Cartilage Injury, run by Kensey Nash Corporation at 2 sites in United States.
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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study enrollment rate was far slower than anticipated. Study was stopped for business purposes.). Results are not available in the source record.
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?
Patient Success (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 25 May 2015.