Defect of Articular CartilageNCT02203071
Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee
An observational study of Defect of Articular Cartilage, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Subjects will be selected among the investigators' patient population who are already scheduled to receive a marrow stimulating procedure (MSP), with or without the addition of BioCartilage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Defect of Articular Cartilage
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Sep 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients recruited from Missouri Orthopaedic Institute's patient population.
Who may be able to join
- Inclusion in the study will be considered when all of the following conditions are met:
- The subject is a candidate for the use of a MSP with microfracture and PRP, with or without augmentation with BioCartilage, for treatment of a focal defect of the knee (trochlea or femoral condyle).
- The subject is 18-years of age or greater
- The subject is able and willing to consent to participate in the study
- The subject is expected to be able to safely undergo MRI at the 1-year follow-up visit (no contraindications present, such as metal implants)
- Infection or inflammatory arthropathy (such as rheumatoid arthritis) is absent in the operative knee
Who cannot join
- Exclusion from the study will be determined by any one of the following conditions being met:
- The subject is undergoing bilateral knee surgery
- The subject is unwilling, or unable to consent due to psychiatric condition or legal incompetence
- The subject is either pregnant, or a prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
Missouri Orthopaedic Institute
Columbia, Missouri, 65212
About this study
Subjects will be selected among the investigators' patient population who are already scheduled to receive a marrow stimulating procedure (MSP), with or without the addition of BioCartilage.
During the surgical operation for MSP, a portion of the patient's blood is taken out and used to form a patch to cover a cartilage defect of the knee. Currently it is considered standard of care to either form the patch using only a portion of the patient's blood, or form the patch using a portion of the patient's blood combined with an FDA-approved augmentation such as BioCartilage.
Read more
This study will collect outcomes data and MRI for patients that are undergoing MSP with and without BioCartilage augmentation, then compare the data between those who received BioCartilage and those who did not.
The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (measured using quality of life indicators, functional outcomes, and MRI) compared to subjects who receive MSP without the use of BioCartilage.
Read the detailed description
Recent developments in the treatment of articular cartilage defects have resulted in several techniques that involve the stimulation of native cellular components for the purpose of differentiation and proliferation in the cartilage defect. Techniques of interest for this study are the use of microfracture combined with platelet rich plasma (PRP), and a recently developed augmentation of the microfracture procedure-BioCartilage.
The microfracture procedure is performed with PowerPick. During the procedure, a patient with focal cartilage defect undergoes arthroscopic debridement of the defect before microfracture is used to create holes in the subchondral plate in order to provide access to mesenchymal stem cells (MSCs). To complete this marrow stimulating procedure (MSP), the microfractured region is filled with PRP harvested intraoperatively from the patient. A fibrin glue is then used to cover the defect and hold the PRP repair in place.
This basic MSP has been shown to regenerate cartilage tissue and improve joint function. Microfracture treatments using PRP are "shown to have good to excellent short-term outcomes in appropriately indicated patients" (Abrams, Mall, Fortier, Roller, \& Cole, 2013), however successful long-term outcomes have not been demonstrated in the literature.
BioCartilage, a novel therapy developed by Arthrex Inc, is implemented as an augmentation of the basic approach of using microfracture and PRP. All aspects of the procedure, as well as indications for the procedure, are the same as the basic MSP described above, except the PRP is combined with BioCartilage powder, which acts as a scaffolding for cellular growth. BioCartilage is an FDA approved augmentation of microfracture treatment with PRP, and the powder itself contains no living cells.
Animal models using BioCartilage have provided data that supports the assertion that the BioCartilage augmentation may improve outcomes for patients who receive it; however there is currently no published human clinical outcomes data available for using BioCartilage (Abrams et al., 2013).
- Conditions
- Defect of Articular Cartilage
- Keywords
- sports, injury, knee, pain, cartilage
- Medical subject headings
- Wounds and Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MSP with BioCartilage | Patients receiving marrow stimulating procedure with BioCartilage adjunct. | |
| MSP without BioCartilage | Patients receiving marrow stimulating procedure without BioCartilage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Repair Tissue Comparison
The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (MRI) compared to subjects who receive MSP without the use of BioCartilage. Quantitative (%fill) and qualitative (tissue quality) MRI assessments of repair tissue will be performed by a musculoskeletal (MSK) radiologist who is blinded to treatment group, and compared for differences between treatment groups.
Measured: 1 year post-operatively
Secondary outcomes (1)
Short Form-12 Health Survey (SF-12)
The 12-item Short Form Survey (SF-12) is a general health questionnaire. The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36). It is designed to have similar performance to the SF-36, while taking less time to complete. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Defect of Articular CartilageStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Principal investigator, James Stannard, University of Missouri-Columbia
- Investigators
- James P Stannard, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203071
- Sponsor's protocol ID
- 1211220
- Status last verified
- Mar 2020
- First submitted
- 19 Jun 2014
- Last updated
- 16 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shah SS, Lee S, Mithoefer K. Next-Generation Marrow Stimulation Technology for Cartilage Repair: Basic Science to Clinical Application. JBJS Rev. 2021 Jan 19;9(1):e20.00090. doi: 10.2106/JBJS.RVW.20.00090.
PubMed 33512974
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee
- ClinicalTrials.gov ID
- NCT02203071
- Acronym / sponsor ID
- 1211220
- Conditions
- Defect of Articular Cartilage
- Keywords
- sports, injury, knee, pain, cartilage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- Jun 2014 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Posted 16 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects will be selected among the investigators' patient population who are already scheduled to receive a marrow stimulating procedure (MSP), with or without the addition of BioCartilage.
During the surgical operation for MSP, a portion of the patient's blood is taken out and used to form a patch to cover a cartilage defect of the knee. Currently it is considered standard of care to either form the patch using only a portion of the patient's blood, or form the patch using a portion of the patient's blood combined with an FDA-approved augmentation such as BioCartilage.
This study will collect outcomes data and MRI for patients that are undergoing MSP with and without BioCartilage augmentation, then compare the data between those who received BioCartilage and those who did not.
The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (measured using quality of life indicators, functional outcomes, and MRI) compared to subjects who receive MSP without the use of BioCartilage.
Detailed description
Recent developments in the treatment of articular cartilage defects have resulted in several techniques that involve the stimulation of native cellular components for the purpose of differentiation and proliferation in the cartilage defect. Techniques of interest for this study are the use of microfracture combined with platelet rich plasma (PRP), and a recently developed augmentation of the microfracture procedure-BioCartilage.
The microfracture procedure is performed with PowerPick. During the procedure, a patient with focal cartilage defect undergoes arthroscopic debridement of the defect before microfracture is used to create holes in the subchondral plate in order to provide access to mesenchymal stem cells (MSCs). To complete this marrow stimulating procedure (MSP), the microfractured region is filled with PRP harvested intraoperatively from the patient. A fibrin glue is then used to cover the defect and hold the PRP repair in place.
This basic MSP has been shown to regenerate cartilage tissue and improve joint function. Microfracture treatments using PRP are "shown to have good to excellent short-term outcomes in appropriately indicated patients" (Abrams, Mall, Fortier, Roller, \& Cole, 2013), however successful long-term outcomes have not been demonstrated in the literature.
BioCartilage, a novel therapy developed by Arthrex Inc, is implemented as an augmentation of the basic approach of using microfracture and PRP. All aspects of the procedure, as well as indications for the procedure, are the same as the basic MSP described above, except the PRP is combined with BioCartilage powder, which acts as a scaffolding for cellular growth. BioCartilage is an FDA approved augmentation of microfracture treatment with PRP, and the powder itself contains no living cells.
Animal models using BioCartilage have provided data that supports the assertion that the BioCartilage augmentation may improve outcomes for patients who receive it; however there is currently no published human clinical outcomes data available for using BioCartilage (Abrams et al., 2013).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSP with BioCartilage | – | –Patients receiving marrow stimulating procedure with BioCartilage adjunct. |
| MSP without BioCartilage | – | –Patients receiving marrow stimulating procedure without BioCartilage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited from Missouri Orthopaedic Institute's patient population.
Key inclusion criteria (6 listed)
- Inclusion in the study will be considered when all of the following conditions are met:
- The subject is a candidate for the use of a MSP with microfracture and PRP, with or without augmentation with BioCartilage, for treatment of a focal defect of the knee (trochlea or femoral condyle).
- The subject is 18-years of age or greater
- The subject is able and willing to consent to participate in the study
- The subject is expected to be able to safely undergo MRI at the 1-year follow-up visit (no contraindications present, such as metal implants)
Key exclusion criteria (4 listed)
- Exclusion from the study will be determined by any one of the following conditions being met:
- The subject is undergoing bilateral knee surgery
- The subject is unwilling, or unable to consent due to psychiatric condition or legal incompetence
- The subject is either pregnant, or a prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MRI Repair Tissue Comparison
Time frame: 1 year post-operatively
The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (MRI) compared to subjects who receive MSP without the use of BioCartilage. Quantitative (%fill) and qualitative (tissue quality) MRI assessments of repair tissue will be performed by a musculoskeletal (MSK) radiologist who is blinded to treatment group, and compared for differences between treatment groups.
1 secondary outcome
Short Form-12 Health Survey (SF-12)
Time frame: Approximately 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33512974Shah SS, Lee S, Mithoefer K. Next-Generation Marrow Stimulation Technology for Cartilage Repair: Basic Science to Clinical Application. JBJS Rev. 2021 Jan 19;9(1):e20.00090. doi: 10.2106/JBJS.RVW.20.00090.
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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.
James P Stannard, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Defect of Articular Cartilage, run by University of Missouri-Columbia at 1 site 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 6 inclusion and 4 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 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
MRI Repair Tissue Comparison (time frame: 1 year post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02203071, which also lists 1 linked publication.
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 16 Mar 2020.