Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee

NCT02203071 | Completed Results DMC

• 1 other identifier: 1211220
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Defect of Articular Cartilage

Keywords

sports; injury; knee; pain; cartilage

Outcome Measures

Primary Outcomes (1)

• MRI Repair Tissue Comparison

  The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (MRI) compared to subjects who receive MSP without the use of BioCartilage. Quantitative (%fill) and qualitative (tissue quality) MRI assessments of repair tissue will be performed by a musculoskeletal (MSK) radiologist who is blinded to treatment group, and compared for differences between treatment groups.

  1 year post-operatively

Secondary Outcomes (1)

• Short Form-12 Health Survey (SF-12)

  Approximately 2 years

Other Outcomes (4)

• Marx Activity Rating Scale

  Approximately 2 years

• Knee Injury and Osteoarthritis Outcomes Score (KOOS)

  Approximately 2 years

• International Knee Documentation Committee (IKDC) Subjective Portion

  Approximately 2 years

Study Arms (2)

MSP with BioCartilage

Patients receiving marrow stimulating procedure with BioCartilage adjunct.

MSP without BioCartilage

Patients receiving marrow stimulating procedure without BioCartilage.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients recruited from Missouri Orthopaedic Institute's patient population.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

Missouri Orthopaedic Institute

Columbia, Missouri, 65212, United States

Location

Related Publications (1)

• 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.

  PMID: 33512974 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Research Project Analyst
• Organization: University of Missouri

jonesvicki@health.missouri.edu

573-882-7583

Study Officials

• James P Stannard, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: July 29, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 16, 2020
• Results First Posted: March 16, 2020

Record last verified: 2020-03

Locations

US (1)