Defect of Articular CartilageCAISNCT00881023
Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration
A study testing Microfracture and Cartilage Autograft Implantation System in people with Defect of Articular Cartilage and Osteochondritis Dissecans, run by DePuy Mitek at 29 sites in 2 countries.
Trial summary
The Cartilage Autograft Implantation System (CAIS) is designed as a single surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Defect of Articular Cartilage, Osteochondritis Dissecans
- What is being tested?
- Microfracture and Cartilage Autograft Implantation System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 29 sitesin 2 countries
- Study dates
- Jul 2010to Dec 2014
- Phase
- Interventional
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A male or female 18 to 55 years of age,
- Has 1 or 2 focal chondral lesions, that require repair, per index knee presenting with moderate to severe knee pain. Each lesion is ≤6 mm in depth and has an area of ≥1 cm2 and ≤10 cm2. Arthroscopic confirmation indicates that the lesions are either a non-OCD lesion between grades I and III (D) or an OCD lesion between grades I and IV(A)
- Prior failed chondral treatment is allowed if the procedure occurred > 6 months for debridement and lavage or > 1 year for marrow stimulation techniques.
Who cannot join
- Have more than 2 chondral lesions on the index knee,
- Bipolar lesions on the index knee,
- Greater than 5 degrees of malalignment,
- Require bilateral surgery
- Have a diagnosis of clinical and/or radiographic disease of the index joint.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States27 sites
MWMC Bentonville Hospital
Bentonville, Arkansas, 72712
TRIA Orthopaedic Center
Bloomington, Minnesota, 55431
University of Virginia
Charlottesville, Virginia, 22908
Harvard Vanguard / New England Baptist Hospital
Chestnut Hill, Massachusetts, 02467
Rush University Medical Center
Chicago, Illinois, 60612
University of Missouri
Columbia, Missouri, 65211
Ohio State University
Columbus, Ohio, 43210
JDP Medical Research, LLC
Denver, Colorado, 80014
Rothman Institute
Egg Harbor, New Jersey, 08234
CORE Orthopaedic Medical Center
Encinitas, California, 92024
Shrock Orthopedic Research
Fort Lauderdale, Florida, 33316
Orthopaedic Research Foundation of the Carolinas
Greenville, South Carolina, 29615
Andrews Institute
Gulf Breeze, Florida, 32561
OrthoIndy
Indianapolis, Indiana, 46237
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0284
OrthoMemphis, PC
Memphis, Tennessee, 38120
University Orthopaedic Group LLC
New Brunswick, New Jersey, 08901
New York University School of Medicine
New York, New York, 10003
Basin Orthopedic Surgical Specialists
Odessa, Texas, 79761
University of Rochester Medical Center
Rochester, New York, 14618
Orlin & Cohen Orthopedic Group
Rockville Centre, New York, 11570
Santa Monica Orthopaedic Group
Santa Monica, California, 90404
Richmond Bone & Joint Clinic, P.A.
Sugar Land, Texas, 77478
Florida Orthopaedics Institute and Research Foundation
Tampa, Florida, 33637
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
Southern California Orthopaedic Group
Van Nuys, California, 91405
UMass Medical Center - Orthopedic Research
Worcester, Massachusetts, 01655
Canada2 sites
Fowler Kennedy Sports Medicine Clinic
New West Minister, Ontario, N6A 3K7
Royal Columbian Hospital
New West Minster, British Columbia, V3L 5P5
About this study
Official title: A Multicenter, Randomized, Pivotal Study to Evaluate the Safety and Efficacy of the Cartilage Autograft Implantation System (CAIS) for the Surgical Treatment of Articular Cartilage Lesions of the Knee
The Cartilage Autograft Implantation System (CAIS) is designed as a single surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region. CAIS is indicated for the repair of articular cartilage lesions and osteochondritis dissecans (OCD) of the knee through cartilage regeneration.
Read the detailed description
The Cartilage Autograft Implantation System (CAIS) is a kit of devices that utilizes morselized autologous hyaline cartilage harvested arthroscopically, affixed onto a synthetic, resorbable implant using a fibrin sealant and implanted in a single surgical procedure. The system is designed as a surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region.
- Being tested
- Microfracture, Cartilage Autograft Implantation System
- Medical subject headings
- Osteochondritis Dissecans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrofractureProcedure or surgery
The microfracture procedure is a standard method for treatment of cartilage damage in which the surgeon will clean the site of your cartilage damage and then will make several small holes in your bone to stimulate your bone marrow with the intention to repair the damaged area with new cartilage tissue
Cartilage Autograft Implantation SystemDevice
A surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Randomized to Microfracture Receives: Procedure: Microfracture |
| 2 | Experimental | Randomized to Device Receives: Device: Cartilage Autograft Implantation System |
| 3 | Experimental | Non-randomized with lesion greater than 6cmˆ2 Receives: Device: Cartilage Autograft Implantation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and efficacy of CAIS compared to microfracture at 24 months post-treatment, with the primary efficacy assessment based on an analysis of superiority of CAIS to microfracture for reduction in knee pain and improvement in function
Measured: 24 Months
Secondary outcomes (1)
To determine the safety of CAIS through 48 months
Measured: 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startJul 2010
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Study was terminated because of very low enrollment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Defect of Articular CartilageStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Mitek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brooks Story, PhD, Study director, DePuy Synthes Mitek Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881023
- Sponsor's protocol ID
- 08-CAIS-05
- Other IDs
- IDE # 11803
- Acronym
- CAIS
- Status last verified
- Aug 2016
- First submitted
- 10 Apr 2009
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: These data will not be used in support of an FDA submission, and the product will not be commercialized. As such, there is no plan to share the IPD.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Pivotal Study to Evaluate the Safety and Efficacy of the Cartilage Autograft Implantation System (CAIS) for the Surgical Treatment of Articular Cartilage Lesions of the Knee
- ClinicalTrials.gov ID
- NCT00881023
- Acronym / sponsor ID
- CAIS / 08-CAIS-05
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated because of very low enrollment rate.
- Enrolment
- 75 participants (actual)
- Lead sponsor
- DePuy MitekIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Apr 2009 (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 Cartilage Autograft Implantation System (CAIS) is designed as a single surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region. CAIS is indicated for the repair of articular cartilage lesions and osteochondritis dissecans (OCD) of the knee through cartilage regeneration.
Detailed description
The Cartilage Autograft Implantation System (CAIS) is a kit of devices that utilizes morselized autologous hyaline cartilage harvested arthroscopically, affixed onto a synthetic, resorbable implant using a fibrin sealant and implanted in a single surgical procedure. The system is designed as a surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: MicrofractureRandomized to Microfracture |
| 2 | Experimental | Device: Cartilage Autograft Implantation SystemRandomized to Device |
| 3 | Experimental | Device: Cartilage Autograft Implantation SystemNon-randomized with lesion greater than 6cmˆ2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A male or female 18 to 55 years of age,
- Has 1 or 2 focal chondral lesions, that require repair, per index knee presenting with moderate to severe knee pain. Each lesion is ≤6 mm in depth and has an area of ≥1 cm2 and ≤10 cm2. Arthroscopic confirmation indicates that the lesions are either a non-OCD lesion between grades I and III (D) or an OCD lesion between grades I and IV(A)
- Prior failed chondral treatment is allowed if the procedure occurred > 6 months for debridement and lavage or > 1 year for marrow stimulation techniques.
Key exclusion criteria (5 listed)
- Have more than 2 chondral lesions on the index knee,
- Bipolar lesions on the index knee,
- Greater than 5 degrees of malalignment,
- Require bilateral surgery
- Have a diagnosis of clinical and/or radiographic disease of the index joint.
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 |
|---|---|---|
| MicrofractureThe microfracture procedure is a standard method for treatment of cartilage damage in which the surgeon will clean the site of your cartilage damage and then will make several small holes in your bone to stimulate your bone marrow with the intention to repair the damaged area with new cartilage tissue | Procedure or surgery | 1 |
| Cartilage Autograft Implantation SystemA surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region | Device | 2, 3 |
Primary outcome
To determine the safety and efficacy of CAIS compared to microfracture at 24 months post-treatment, with the primary efficacy assessment based on an analysis of superiority of CAIS to microfracture for reduction in knee pain and improvement in function
Time frame: 24 Months
1 secondary outcome
To determine the safety of CAIS through 48 months
Time frame: 48 Months
Results and safety
The study was stopped early (reason given: Study was terminated because of very low enrollment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Individual participant dataSharing planned: No. These data will not be used in support of an FDA submission, and the product will not be commercialized. As such, there is no plan to share the IPD.
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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.
Brooks Story, PhD study director
DePuy Synthes Mitek Sports Medicine
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfracture and Cartilage Autograft Implantation System in people with Defect of Articular Cartilage and Osteochondritis Dissecans, run by DePuy Mitek at 29 sites in 2 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 5 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 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Canada. 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 was stopped early (reason given: Study was terminated because of very low enrollment rate.). 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?
To determine the safety and efficacy of CAIS compared to microfracture at 24 months post-treatment, with the primary efficacy assessment based on an analysis of superiority of CAIS to microfracture for reduction in knee pain and improvement in function (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 3 Aug 2016.