Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee
Condition: Knee Injuries
MeSH terms: Knee Injuries; Fractures, Stress
Study type: Observational

Summary: 
      This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured
      lesion (investigational) and microfracture alone (control) for up to 5 years from treatment
      in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post
      approval study for these Protocols, in support of a commercial application. The lesions
      treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of articular cartilage,
      grade 3 or 4 (either ICRS or Outerbridge classification) on the medial and lateral femoral
      condyles of the knee, and were classified as either acute or chronic.
    

Detailed description: 
      Cartilage repair currently remains a problematic orthopedic concern with no effective
      solution. The development of new surgical techniques or therapies is critical in meeting this
      medical need.

      Clinical data regarding the long-term durability of repair tissue resulting from cartilage
      repair techniques such as microfracture, autologous chondrocyte implantation or mosaicplasty
      is lacking. Only two studies, one comparative and one uncontrolled, have examined long-term
      repair outcomes (over 4 years). These studies reinforced the concept that further studies are
      needed to identify a technique or product that will lead to long-term clinical benefit
      through improved cartilage repair efficacy.

      BST-CarGel® is a medical device derived from chitosan applied to a microfractured lesion and
      has been shown to promote the quantity and quality of cartilage repair tissue in animals. The
      efficacy and safety of BST-CarGel® is currently being evaluated in humans as compared to the
      standard of care treatment, microfracture, in a 12 month international study in Canada,
      Europe and Korea under Protocols CG-CIP01-P and CG-CIP02-P. When these protocols were
      designed and carried out, the BST-CarGel® technology belonged to BioSyntech Canada Inc.
      Afterwards, the technology was acquired by Piramal Healthcare (Canada) Ltd. which is now the
      owner of the technology and the sponsor for this Extension Study CG-C1P04.

      This follow-up study will evaluate the long-term effects (5 yrs) of BST-CarGel® +
      microfracture and microfracture alone in subjects treated in the pivotal and sub-studies.

      All eligible subjects (maximum 80) who were treated under Protocols CG-CIP01-P and CG-CIP02-P
      and completed the required 12 month follow-up period will be asked to participate in this
      follow-up study.

      The stratification from Protocols CG-CIP01-P and CG-CIP02-P (investigational site and lesion
      type) will be retained for the purposes of the follow-up study, and all third parties such as
      the MRI central reading facility will remain blinded to the treatment received under
      Protocols CG-CIP01-P and CG-CIP02-P.

      Comparisons between the two treatment groups will be performed.

      The following assessments will be done annually at years 3 and/or 4 and 5 post -treatment
      under Protocols CG-CIP01-P and CG-CIP02-P in subjects treated with BST-CarGel + microfracture
      or microfracture alone:

        1. Analyses of tissue repair will be carried out based on the degree of lesion filling and
           quality of repair tissue using MRI

        2. The general health status of subjects will be captured in the case report form (CRF) and
           will include the subject's overall health status, treated knee status, adverse events
           (AEs) and concomitant medications.

        3. The assessment of the subject's knee pain, stiffness, functional ability and quality of
           life through self-assessment questionnaires (Western Ontario and McMaster Universities
           osteoarthritis index (WOMAC) and short-form-36 (SF-36v2)
    

Intervention name(s): Microfracture with BST-CarGel; Microfracture without BST-CarGel
Intervention type(s): Device; Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients that have been treated under either protocol CG-CIP01 or CG-CIP02
      
Keywords: Cartilage repair; Cartilage; Knee; Knee Pain; Microfracture; Arthroscopy; Bone Marrow Stimulation; Chondrogenesis; Scaffold; Chitosan; Articular Cartilage Repair