Articular Cartilage Defect Grade III or IV of the KneeNCT01799876
Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery
A study testing Autologous Cell and Standard microfracture arthroscopic surgery in people with Articular Cartilage Defect Grade III or IV of the Knee, run by Fondren Orthopedic Group L.L.P. at 1 site in United States.
Trial summary
The purpose of this study is to assess the potential benefit of enhancing knee surgery for cartilage injury using some of the patient's own cells, taken from fat tissue, that may be able to help cartilage to regenerate. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Articular Cartilage Defect Grade III or IV of the Knee
- What is being tested?
- Autologous Cell and Standard microfracture arthroscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Aug 2017
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects undergoing microfracture surgery for the repair of articular cartilage
- Osteochondral defect Grade III or IV
- Age 18 to 68 years
- Sufficient subcutaneous adipose tissue to yield 20-30 cc of lipoaspirate
- Written informed consent
- Ability to speak, read and write English or Spanish
Who cannot join
- Inability to speak, read and write English or Spanish
- Evidence of malignant disorder/neoplasm in past 24 months
- History of basal cell carcinoma
- History of smoking and not committed to give up
- Chronic skin conditions
- Connective, metabolic or skin disease
Show all 18Show fewer
- Evidence of active infection
- Pregnancy or lactating for female subjects
- Diabetes Type I or II
- Current steroid use
- Immunosuppressive medication
- Renal failure (creatine > 1.8 mg/dL)
- Hepatic failure (AST, ALT >2 times normal values; bilirubin >2.0 mg/dL)
- Inflammatory joint diseases of the knee that indicate additional, conflating therapies
- Joint infection within the past 6 months
- Meniscal resection of greater than 50% prior to, or at time of procedure
- Uncorrected joint instability
- Joint malalignment > 5 degrees
Trial locations and contacts
1 site in 1 country.
United States1 site
Fondren Orthopedic Group, L.L.P.
Houston, Texas, 77030
About this study
Official title: Autologous Cell Therapy Enhancement of Microfracture Surgery
The purpose of this study is to assess the potential benefit of enhancing knee surgery for cartilage injury using some of the patient's own cells, taken from fat tissue, that may be able to help cartilage to regenerate.
Read the detailed description
Participation in this study will allow the surgical team to remove a small amount of fat (20 to 30 ml, or between 1 and 2 tablespoons) from just below the skin in the belly region that will be processed to remove regenerative cells, which will then inserted into the knee to the damaged cartilage. These cells may encourage healing at the surgical site, although whether or how much they encourage healing is unknown. Determining whether such improved healing occurs is the purpose of this study.
Some patients will have the fat removed and cells inserted in their knee, and other patients will not have the fat removed or cells inserted. To which group patients are assigned is determined by a random process, similar to flipping a coin. The surgery is the same in all other ways for all patients.
Participation will require attending regularly scheduled postoperative visits, having 3 MRI tests, and answering a short survey. No additional visits other beyond those normally scheduled for postsurgical care are required.
- Being tested
- Autologous Cell, Standard microfracture arthroscopic surgery
- Keywords
- knee, cartilage, microfracture, cell therapy
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous CellProcedure or surgery
Standard microfracture arthroscopic surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Autologous Cell | Experimental | Regenerative cells obtained from autologous fat are administered in the knee at microfracture site. Receives: Procedure: Autologous Cell |
| Control | Sham comparator | Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested). Receives: Procedure: Standard microfracture arthroscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging (MRI) for osteochondral defect filling
Filling will be scored by quartile with 1 point for less than 25% filling of the defect and 4 points for greater than 75% filling. Evaluated by radiologist who is blinded to group assignment.
Measured: 12 months
Secondary outcomes (4)
Pain Scores on Numerical Rating Scale
Measured: up to 1 year
Knee Injury and Osteoarthritis Outcomes Survey (KOOS)
Survey
Measured: 12 months postop
Knee Range of Motion
Measured: up to 1 year
Number of Patients with Adverse Events as a Measure of Safety
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage Defect Grade III or IV of the KneeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondren Orthopedic Group L.L.P.
- Sponsor type
- University, hospital or other
- Collaborators
- InGeneron, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert L Burke, MD, Principal investigator, Fondren Orthopedic Group L.L.P.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799876
- Sponsor's protocol ID
- FOG-TOH125
- Status last verified
- Jan 2019
- First submitted
- 22 Feb 2013
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Cell Therapy Enhancement of Microfracture Surgery
- ClinicalTrials.gov ID
- NCT01799876
- Acronym / sponsor ID
- FOG-TOH125
- Keywords
- knee, cartilage, microfracture, cell therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fondren Orthopedic Group L.L.P.University, hospital or other
- Collaborators
- InGeneron, Inc.
- Study start
- Feb 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 27 Feb 2013 (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 purpose of this study is to assess the potential benefit of enhancing knee surgery for cartilage injury using some of the patient's own cells, taken from fat tissue, that may be able to help cartilage to regenerate.
Detailed description
Participation in this study will allow the surgical team to remove a small amount of fat (20 to 30 ml, or between 1 and 2 tablespoons) from just below the skin in the belly region that will be processed to remove regenerative cells, which will then inserted into the knee to the damaged cartilage. These cells may encourage healing at the surgical site, although whether or how much they encourage healing is unknown. Determining whether such improved healing occurs is the purpose of this study.
Some patients will have the fat removed and cells inserted in their knee, and other patients will not have the fat removed or cells inserted. To which group patients are assigned is determined by a random process, similar to flipping a coin. The surgery is the same in all other ways for all patients.
Participation will require attending regularly scheduled postoperative visits, having 3 MRI tests, and answering a short survey. No additional visits other beyond those normally scheduled for postsurgical care are required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Cell | Experimental | Procedure: Autologous CellRegenerative cells obtained from autologous fat are administered in the knee at microfracture site. |
| Control | Sham comparator | Procedure: Standard microfracture arthroscopic surgeryStandard arthroscopy with sham lipoplasty procedure (no fat cells harvested). |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects undergoing microfracture surgery for the repair of articular cartilage
- Osteochondral defect Grade III or IV
- Age 18 to 68 years
- Sufficient subcutaneous adipose tissue to yield 20-30 cc of lipoaspirate
- Written informed consent
Key exclusion criteria (18 listed)
- Inability to speak, read and write English or Spanish
- Evidence of malignant disorder/neoplasm in past 24 months
- History of basal cell carcinoma
- History of smoking and not committed to give up
- Chronic skin conditions
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 |
|---|---|---|
| Autologous Cell | Procedure or surgery | Autologous Cell |
| Standard microfracture arthroscopic surgery | Procedure or surgery | Control |
Primary outcome
Magnetic Resonance Imaging (MRI) for osteochondral defect filling
Time frame: 12 months
Filling will be scored by quartile with 1 point for less than 25% filling of the defect and 4 points for greater than 75% filling. Evaluated by radiologist who is blinded to group assignment.
4 secondary outcomes
Pain Scores on Numerical Rating Scale
Time frame: up to 1 year
Knee Injury and Osteoarthritis Outcomes Survey (KOOS)
Time frame: 12 months postop
Knee Range of Motion
Time frame: up to 1 year
Number of Patients with Adverse Events as a Measure of Safety
Time frame: up to 1 year
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 10 Jan 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.
Robert L Burke, MD principal investigator
Fondren Orthopedic Group L.L.P.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Cell and Standard microfracture arthroscopic surgery in people with Articular Cartilage Defect Grade III or IV of the Knee, run by Fondren Orthopedic Group L.L.P. 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 18 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 10 Jan 2019. 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. Some participants in this study may receive a placebo. 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?
Magnetic Resonance Imaging (MRI) for osteochondral defect filling (time frame: 12 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 10 Jan 2019.