Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02203071
Study type Observational
Source University of Missouri-Columbia
Contact
Status Completed
Phase
Start date June 2014
Completion date September 2018

See also
  Status Clinical Trial Phase
Completed NCT01473199 - BioPoly RS Knee Registry Study for Cartilage Defect Replacement N/A
Active, not recruiting NCT01670617 - DeNovo NT Natural Tissue Graft Stratified Knee Study N/A
Active, not recruiting NCT01347892 - DeNovo NT Ankle LDC Study N/A
Completed NCT01626677 - Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect Phase 3
Active, not recruiting NCT02855073 - Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects Phase 2
Completed NCT01290991 - A Study to Evaluate the Safety of Augmentâ„¢ Bone Graft N/A
Terminated NCT01400607 - Neocartilage Implant to Treat Cartilage Lesions of the Knee Phase 3
Terminated NCT00881023 - Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration N/A
Terminated NCT02542566 - Protected Versus Early Weight Bearing Post Microfracture Surgery N/A
Completed NCT02696876 - Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair N/A
Active, not recruiting NCT02524509 - the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee Phase 4
Active, not recruiting NCT02537067 - Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle Phase 3
Recruiting NCT02519881 - the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle Phase 4
Active, not recruiting NCT02539030 - Comparison of Efficacy and Safety of Microfracture and Modified Microfracture Phase 4
Active, not recruiting NCT02659215 - HyaloFAST Trial for Repair of Articular Cartilage in the Knee N/A
Terminated NCT01410136 - Chondrofix Osteochondral Allograft Prospective Study N/A
Active, not recruiting NCT00885729 - Mesenchymal Stem Cells in a Clinical Trial to Heal Articular Cartilage Defects Phase 1
Terminated NCT01246635 - Smith & Nephew's European Trufit Study N/A