Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery

Fondren Orthopedic Group L.L.P.48 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Articular Cartilage Defect Grade III or IV of the Knee

Interventions

Autologous CellPROCEDURE

Standard microfracture arthroscopic surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 68 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondren Orthopedic Group, L.L.P.

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Pain Scores on Numerical Rating Scale

Time frame: up to 1 year

Knee Injury and Osteoarthritis Outcomes Survey (KOOS)

Survey

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

Data from ClinicalTrials.gov

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