Recruitment

Recruitment Status
Completed
Estimated Enrollment
60

Inclusion Criterias

Infection or inflammatory arthropathy (such as rheumatoid arthritis) is absent in the operative knee
The subject is 18-years of age or greater
The subject is able and willing to consent to participate in the study
...
Infection or inflammatory arthropathy (such as rheumatoid arthritis) is absent in the operative knee
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)
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).

Exclusion Criterias

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
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

Summary

Conditions
Defect of Articular Cartilage
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 microf...

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).

Inclusion Criterias

Infection or inflammatory arthropathy (such as rheumatoid arthritis) is absent in the operative knee
The subject is 18-years of age or greater
The subject is able and willing to consent to participate in the study
...
Infection or inflammatory arthropathy (such as rheumatoid arthritis) is absent in the operative knee
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)
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).

Exclusion Criterias

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
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

Locations

Columbia, Missouri, 65212
Columbia, Missouri, 65212

Tracking Information

NCT #
NCT02203071
Collaborators
Arthrex, Inc.
Investigators
  • Principal Investigator: James P Stannard, MD University of Missouri-Columbia
  • James P Stannard, MD University of Missouri-Columbia