Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Articular Cartilage Defect Grade III or IV of the Knee |
Procedure: Autologous Cell Procedure: Standard microfracture arthroscopic surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Autologous Cell Therapy Enhancement of Microfracture Surgery |
- Magnetic Resonance Imaging (MRI) for osteochondral defect filling [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Pain Scores on Numerical Rating Scale [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
- Knee Injury and Osteoarthritis Outcomes Survey (KOOS) [ Time Frame: 12 months postop ] [ Designated as safety issue: No ]Survey
- Knee Range of Motion [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
- Number of Patients with Adverse Events as a Measure of Safety [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Autologous Cell
Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.
|
Procedure: Autologous Cell |
|
Sham Comparator: Control
Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested).
|
Procedure: Standard microfracture arthroscopic surgery |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 68 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Robert L Burke, MD | 713-436-3488 | mc104@fondren.com |
| Contact: Mai-Ling Camacho | 713-436-3488 | mc104@fondren.com |
| United States, Texas | |
| Fondren Orthopedic Group, L.L.P. | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Robert L Burke, MD | |
| Principal Investigator: | Robert L Burke, MD | Fondren Orthopedic Group L.L.P. |
More Information
No publications provided
| Responsible Party: | Fondren Orthopedic Group L.L.P. |
| ClinicalTrials.gov Identifier: | NCT01799876 History of Changes |
| Other Study ID Numbers: | FOG-TOH125 |
| Study First Received: | February 22, 2013 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Fondren Orthopedic Group L.L.P.:
|
knee cartilage microfracture cell therapy |
ClinicalTrials.gov processed this record on May 16, 2013