Back to resultsUse of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery
Primary Purpose
Articular Cartilage Defect Grade III or IV of the Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Autologous Cell
Standard microfracture arthroscopic surgery
Sponsored by
About this trial
This is an interventional treatment trial for Articular Cartilage Defect Grade III or IV of the Knee focused on measuring knee, cartilage, microfracture, cell therapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Fondren Orthopedic Group, L.L.P.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Autologous Cell
Control
Arm Description
Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.
Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pain Scores on Numerical Rating Scale
Knee Injury and Osteoarthritis Outcomes Survey (KOOS)
Survey
Knee Range of Motion
Number of Patients with Adverse Events as a Measure of Safety
Full Information
NCT ID
NCT01799876
First Posted
February 22, 2013
Last Updated
January 9, 2019
Sponsor
Fondren Orthopedic Group L.L.P.
Collaborators
InGeneron, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01799876
Brief Title
Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery
Official Title
Autologous Cell Therapy Enhancement of Microfracture Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondren Orthopedic Group L.L.P.
Collaborators
InGeneron, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Cartilage Defect Grade III or IV of the Knee
Keywords
knee, cartilage, microfracture, cell therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous Cell
Arm Type
Experimental
Arm Description
Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested).
Intervention Type
Procedure
Intervention Name(s)
Autologous Cell
Intervention Type
Procedure
Intervention Name(s)
Standard microfracture arthroscopic surgery
Primary Outcome Measure Information:
Title
Magnetic Resonance Imaging (MRI) for osteochondral defect filling
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain Scores on Numerical Rating Scale
Time Frame
up to 1 year
Title
Knee Injury and Osteoarthritis Outcomes Survey (KOOS)
Description
Survey
Time Frame
12 months postop
Title
Knee Range of Motion
Time Frame
up to 1 year
Title
Number of Patients with Adverse Events as a Measure of Safety
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Burke, MD
Organizational Affiliation
Fondren Orthopedic Group L.L.P.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondren Orthopedic Group, L.L.P.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery
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