Clinical trial NCT02203071: Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee
Official title: Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Defect of Articular Cartilage
Keywords: sports
injury
knee
pain
cartilage
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2014-07-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited from Missouri Orthopaedic Institute's patient population.

Brief summary: Subjects will be selected among the investigators' patient population who are already scheduled to receive a marrow stimulating procedure (MSP), with or without the addition of BioCartilage.

During the surgical operation for MSP, a portion of the patient's blood is taken out and used to form a patch to cover a cartilage defect of the knee. Currently it is considered standard of care to either form the patch using only a portion of the patient's blood, or form the patch using a portion of the patient's blood combined with an FDA-approved augmentation such as BioCartilage.

This study will collect outcomes data and MRI for patients that are undergoing MSP with and without BioCartilage augmentation, then compare the data between those who received BioCartilage and those who did not.

The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (measured using quality of life indicators, functional outcomes, and MRI) compared to subjects who receive MSP without the use of BioCartilage.

Detailed 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 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).

Eligibility criteria: Inclusion Criteria:

I. Inclusion in the study will be considered when all of the following conditions are met:

* 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).
* 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)
* Infection or inflammatory arthropathy (such as rheumatoid arthritis) is absent in the operative knee

Exclusion Criteria:

II. Exclusion from the study will be determined by any one of the following conditions being met:

* 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

Primary outcomes:
measure: MRI Repair Tissue Comparison
timeFrame: 1 year post-operatively
Secondary outcomes:
measure: Short Form-12 Health Survey (SF-12)
timeFrame: Approximately 2 years
Other outcomes:
measure: Marx Activity Rating Scale
timeFrame: Approximately 2 years
measure: Knee Injury and Osteoarthritis Outcomes Score (KOOS)
timeFrame: Approximately 2 years
measure: International Knee Documentation Committee (IKDC) Subjective Portion
timeFrame: Approximately 2 years
measure: Number of Participants Who Were Able To Return To Return to Work or Sports Activity
timeFrame: Approximately 2 years
Locations:
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: James P Stannard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah SS, Lee S, Mithoefer K. Next-Generation Marrow Stimulation Technology for Cartilage Repair: Basic Science to Clinical Application. JBJS Rev. 2021 Jan 19;9(1):e20.00090. doi: 10.2106/JBJS.RVW.20.00090.