0
Scientific Articles   |    
Novel Scaffold-Based BST-CarGel Treatment Results in Superior Cartilage Repair Compared with Microfracture in a Randomized Controlled Trial
William D. Stanish, MD1; Robert McCormack, MD2; Francisco Forriol, MD3; Nicholas Mohtadi, MD4; Stéphane Pelet, MD, PhD5; Jacques Desnoyers, MD6; Alberto Restrepo, MD7; Matthew S. Shive, PhD7
1 Department of Surgery, Dalhousie University, 5595 Fenwick Street, Suite 311, Halifax, NS B3H 4M2, Canada. E-mail address: wstanish@ns.sympatico.ca
2 Department of Orthopaedic Surgery, University of British Columbia, 65 Richmond Street, Suite 102, New Westminster, BC V3L 5P5, Canada. E-mail address: drbobmccormack@me.com
3 School of Medicine, CEU San Pablo University, Campus Monteprincipe, 28668 Boadilla del Monte, Madrid, Spain. E-mail address: fforriol@me.com
4 University of Calgary Sport Medicine Centre, 2500 University Drive N.W., Calgary, Alberta T2N 1N4, Canada. E-mail address: mohtadi@ucalgary.ca
5 Département d’orthopédie, Hôpital de l’Enfant-Jésus, Centre de Recherche du CHU de Québec, 1401 18ème Rue, local B-2416, Québec, QC G1J 1Z4, Canada. E-mail address: stephane.pelet.ortho@gmail.com
6 Hôpital Charles LeMoyne, 3120 Taschereau Boulevard, Greenfield Park, QC J4V 2H1, Canada. E-mail address: genoumenisque@hotmail.com
7 Piramal Life Sciences, Bio-Orthopaedic Division, 475 Armand-Frappier Boulevard, Laval, QC H7V 4B3, Canada. E-mail address for A. Restrepo: Alberto.Restrepo@piramal.com. E-mail address for M.S. Shive: shive@videotron.ca
View Disclosures and Other Information
  • Disclosure statement for author(s): PDF

Investigation performed at twenty-six clinical sites in Canada, Spain, and South Korea

A commentary by Michael Khazzam, MD, is linked to the online version of this article at jbjs.org.



Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2013 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2013 Sep 18;95(18):1640-1650. doi: 10.2106/JBJS.L.01345
5 Recommendations (Recommend) | 3 Comments | Saved by 3 Users Save Case

Abstract

Background: 

Microfracture, the standard of care, is recognized to be an incomplete solution for cartilage damage. BST-CarGel, a chitosan-based medical device, is mixed with autologous whole blood and is applied to a microfractured cartilage lesion in which it physically stabilizes the clot and guides and enhances marrow-derived repair. An international, multicenter, randomized controlled trial was conducted to evaluate BST-CarGel treatment compared with microfracture alone in the repair of cartilage lesions in the knee.

Methods: 

Eighty patients between the ages of eighteen and fifty-five years with a single, symptomatic focal lesion on the femoral condyles were randomized to BST-CarGel and microfracture treatment (n = 41) or microfracture treatment alone (n = 39). The primary end points of repair tissue quantity and quality at twelve months were assessed by quantitative three-dimensional magnetic resonance imaging measuring the degree of lesion filling and T2 relaxation time with use of standardized one and twelve-month posttreatment scans. The secondary end point at twelve months was clinical benefit determined with the Western Ontario and McMaster Universities Osteoarthritis Index. The tertiary end point was quality of life determined by the Short Form-36. Safety was assessed through the recording of adverse events.

Results: 

Patient baseline characteristics were similar in the two groups, although baseline lesion areas were slightly larger on quantitative magnetic resonance imaging for the BST-CarGel group compared with the microfracture group. Blinded quantitative magnetic resonance imaging analysis demonstrated that, at twelve months, when compared with microfracture treatment alone, BST-CarGel treatment met both primary end points by achieving statistical superiority for greater lesion filling (p = 0.011) and more hyaline cartilage-like T2 values (p = 0.033). The lesion filling values were 92.8% ± 2.0% for the BST-CarGel treatment group and 85.2% ± 2.1% for the microfracture treatment group, and the mean T2 values were 70.5 ± 4.5 ms for the BST-CarGel treatment group and 85.0 ± 4.9 ms for the microfracture treatment group. Western Ontario and McMaster Universities Osteoarthritis Index subscales for pain, stiffness, and function yielded equivalent improvement for both groups at twelve months, which were significant (p < 0.0001) from baseline. Treatment safety profiles were considered comparable.

Conclusions: 

At twelve months, BST-CarGel treatment resulted in greater lesion filling and superior repair tissue quality compared with microfracture treatment alone. Clinical benefit was equivalent between groups at twelve months, and safety was similar.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Figures in this Article
    Sign In to Your Personal ProfileSign In To Access Full Content
    Not a Subscriber?
    Get online access for 30 days for $35
    New to JBJS?
    Sign up for a full subscription to both the print and online editions
    Register for a FREE limited account to get full access to all CME activities, to comment on public articles, or to sign up for alerts.
    Register for a FREE limited account to get full access to all CME activities
    Have a subscription to the print edition?
    Current subscribers to The Journal of Bone & Joint Surgery in either the print or quarterly DVD formats receive free online access to JBJS.org.
    Forgot your password?
    Enter your username and email address. We'll send you a reminder to the email address on record.

     
    Forgot your username or need assistance? Please contact customer service at subs@jbjs.org. If your access is provided
    by your institution, please contact you librarian or administrator for username and password information. Institutional
    administrators, to reset your institution's master username or password, please contact subs@jbjs.org

    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
    CME Activities Associated with This Article
    Submit a Comment
    Please read the other comments before you post yours. Contributors must reveal any conflict of interest.
    Comments are moderated and will appear on the site at the discretion of JBJS editorial staff.

    * = Required Field
    (if multiple authors, separate names by comma)
    Example: John Doe





    Related Content
    The Journal of Bone & Joint Surgery
    JBJS Case Connector
    Topic Collections
    Related Audio and Videos
    PubMed Articles
    Clinical Trials
    Readers of This Also Read...
    JBJS Jobs
    11/15/2013
    LA - Ochsner Health System
    04/02/2014
    WV - Charleston Area Medical Center
    12/04/2013
    NY - Icahn School of Medicine at Mount Sinai
    05/03/2012
    CA - UCLA/OH Department of Orthopaedic Surgery