Management of Articular Cartilage Injuries by MikeJenny

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									         Management of
   Articular Cartilage Injuries


            James J. York, MD
        Chesapeake Orthopaedic &
            Sports Medicine
                 jjyork01@att.net

                                        C-00029.A 08/2006




Cartilage Injury Occurs in Many Forms

  Trauma
    Sports or work related
  Chronic instability
    Long term effects: ACL and other
  Meniscal deficiency
  Mal-
  Mal-aligned joint - deformity
    Varus / Valgus
  Osteochondritis Dissecans [OCD]
            pre-
  Genetic pre-disposition / early
  arthritis


                                        C-00029.A 08/2006




  What Is Partial Cartilage Loss?

     A piece of the joint surface cartilage is
     lost from trauma or local degeneration
     May result from a lifetime of overuse or
     injury
      May result from one single injury




                                        C-00029.A 08/2006




                                                            1
Cartilage Loss: Gross Description

                            tread”
  Focal Loss of the normal “tread” on the joint
  Normal cartilage:
    Like slippery vinyl or slippery leather
  Degenerated or damaged cartilage:
    Like soft spongy plastic earlier on
    Eventually behaves (feels and looks) like cooked
    crabmeat
    Finally cartilage wears away leaving bare bone


                                                           C-00029.A 08/2006




 Changes & Symptoms With Cartilage Damage


 Lining of joint (synovium) becomes thick and
 inflamed
    Feel: pain; Swelling; Warmth
 Synovium produces less viscous lubrication
    Feel: stiffness
 Joint surfaces become irregular, soft
    Feel: clicking and stiffness




                                                           C-00029.A 08/2006




Significant Public Health Issue

 Occurs frequently
 Cause significant
 disability in relatively
 young patients
    Limits
       Employment
       Sport participation
       Activities of daily living
                  end-
 Can progress to end-
 stage osteoarthritis           25 y.o. HVAC technician with knee pain.
                                                   Courtesy of James York, MD




                                                           C-00029.A 08/2006




                                                                                2
Cartilage Damage Not Uncommon

Literature confirms:
  Approximately 60% of all
  knee arthroscopies reveal
  articular cartilage damage1
  Significant defects in ~
  20% of all knees1
Articular cartilage:                  Arthroscopic Assessment
                                                        Courtesy of James York, MD
  Poor intrinsic capacity for
  repair:                       1 Curl, et al. Cartilage Injuries: A Review of 31,516 Knee

                                Arthroscopies, The Journal of Arthroscopy and Related Surgery –
  Avascular, cells              Aug. 1997
                                1 Hjelle,
                                       et al. Articular Cartilage Defects in 1,000 Knee Arthoscopies
  (chondrocytes) cannot         The Journal of Arthroscopy and Related Surgery Sept. 2002


  migrate to area of repair                                           C-00029.A 08/2006




A Longstanding Clinical Challenge

  Hunter, 1743:
    “From Hippocrates to the present age … when
                                        recovered.”
    cartilage is destroyed, it is never recovered.”
  Paget, 1851:
    “ … no instances in which a lost portion of cartilage
    has been restored … “.
  Campbell’
  Campbell’s Orthopedics, Sisk, 1992:
    “ … ability to heal defects involving only the
                                     limited.”
    articular cartilage is extremely limited.”


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Hyaline Cartilage Structure




                                                                      C-00029.A 08/2006




                                                                                                       3
 Hyaline Cartilage Structure

       stuff”
  The “stuff” of cartilage:
     Type II Collagen – provides tensile strength
     Proteoglycans
        huge complex macromolecules
        Contain large positive and negative charged particles
           Repel each other and trap and channel water molecules
     Water: 65% - 80%




                                                        C-00029.A 08/2006




Hyaline Cartilage :                         Proteoglycans




                                                        C-00029.A 08/2006




Hyaline Cartilage: Composition and
Function

                                Type II Collagen
                                Fibers
                                Chondrocyte


                                Proteoglycans



• Chondrocytes (5 %)
   - Create and maintain collagen and other matrix proteins
   - Only chondrocytes are genetically predisposed to this function
• Proteoglycans (5-10 %)
   - Bind water molecules and provide shear strength
• Type II Collagen
   - Provide tensile strength                           C-00029.A 08/2006




                                                                            4
 Cartilage Biomechanics

   Resists high loads
     Behaves like a solid and like a fluid:
        (viscoelastic)
  Indents and then slowly restores shape
  Cycles of joint loading and release assist in
  nutrient transport throughout the cartilage




                                                      C-00029.A 08/2006




 Cartilage Injury Response

   Unique tissue:
     No vascular, nerve or lymphatic supply
      Superficial lacerations: do not heal
         No inflammatory response to tissue damage
            (unless underlying subchondral bone affected)
         Chondrocytes cannot migrate to and repopulate
        damaged area




                                                      C-00029.A 08/2006




 Cartilage Injury Response

Injury that penetrates subchondral bone
 Bleeding -> Fibrin clot -> Inflammatory response
 Fibrocartilage: lacks unique structure and
 properties of hyaline cartilage
    Random collagen fibrils
    Softer; Easier to damage and deform
    Poor connection with adjacent hyaline cartilage




                                                      C-00029.A 08/2006




                                                                          5
   Hyaline Cartilage vs. Fibrocartilage
Hyaline cartilage consists of:
  Proteoglycan aggregate, Collagen
  Types: II, IX, XI
  Organized collagen fiber
  orientation




Fibrocartilage consists of:
  Proteoglycan, Collagen Type I
  Unorganized collagen fiber
  orientation

                                                 C-00029.A 08/2006




  Injury Classification

    Grade:
  1 – Softening / superficial cracks
  2 – To transitional zone ( < 50% thickness)
  3 – Deep Zone ( > 50% thickness)
  4 – Exposed subchondral bone




                                                 C-00029.A 08/2006




  Goals of Cartilage Repair

     Restore articular
     cartilage surface
     Relieve symptoms &
     improve function
             bio-
     Match bio-mechanical
     properties of normal
     hyaline cartilage
     Prevent or slow
     progression of focal   Get our patients “back in the game”
     chondral injury to end
     stage arthritis

                                                 C-00029.A 08/2006




                                                                     6
Treatment Options




                               Courtesy of Brian Cole, MD   C-00029.A 08/2006




Treatment Options: Large vs. Small:

          < 2cm2 (d. < 1.6 cm) > 2cm2 (d. > 1.6 cm)




                                                            C-00029.A 08/2006




Treatment Options : Younger Patient With
Focal Joint Damage

                Focal”
  Behaves Like “Focal”
  Arthritis
  Previous solutions:
                          up”
    Debridement “clean up”–
    not very effective
                    arthroplasty”
    “Microfracture arthroplasty”
    – short term partial relief
    Knee replacement –
    problematic in the younger
    patient




                                                            C-00029.A 08/2006




                                                                                7
Treatment Options: Debridement

Strengths:
  Arthroscopic
                   sub-
  Does not violate sub-
  chondral bone
  Temporary pain relief
Limitations:
  Lack of tissue fill /
  restoration
  Low prospects for long term
  result




                                                    C-00029.A 08/2006




Treatment Options: MicroFracture

Strengths:
   Arthroscopic
   Relatively simple
   procedure
Limitations:
            fibro-
   Creates fibro-cartilage /
   poor wear characteristics
   More effective on smaller
   defects
               non- weight-
   6-8 weeks non-weight-
   bearing & motion exercise
   to optimize results

                                  Courtesy of James York, MD
                                                    C-00029.A 08/2006




Treatment Options: OsteoChondral
Autografting
Autografting
Strengths:
   May be performed
   arthroscopically
   Fills defect with native
   cartilage
Limitations:
   Limited to small defects
   Donor site morbidity
   No lateral integration
   Congruity of joint difficult
      re-
   to re-produce with
   multiple plugs
                                         Courtesy of Brian Cole, MD
                                                    C-00029.A 08/2006




                                                                        8
                                  Allografts
 Treatment Options: Osteochondral Allografts

    Strengths:
        Bone fixation
        Hyaline cartilage
    Limitations:
        Limited supply
        Rare Disease
        transmission
        ?? Viability of
        chondrocytes                                Courtesy of Brian Cole, MD

        Non-
        Non-union
                                                                  C-00029.A 08/2006




 Treatment Options: Autologous Chondrocyte
 Implantation (ACI)

  Strengths:
                    hyaline-
     Can produce hyaline-like
     cartilage
     Can fill defects regardless
     of size with functional repair
     tissue.
     Moderate to large defects
     that have failed previous
     intervention
     “Biologic Joint
     Replacement”
     Replacement”
                                              Courtesy of James York, MD
  Limitations:
     More invasive
     Expense
     Longer recovery – return to
     sports
                                                                  C-00029.A 08/2006




Small Chondral Lesions

                                 1
             Lesion < 2 cm2
             (1.6 cm Diameter)


  Primary Treatment              Secondary
                                 Treatment


  Low-          High-            Low / High
 Demand        Demand             Demand
                                                             Courtesy of Jack Farr, MD



• Debride       Debride           ACI             1
                                                    Cole & Farr, Operative Techniques in
• MicroFx       MicroFx           Auto OC         Orthopaedics, April 2001
               Auto              Graft            1
                                                    Mandelbaum et al. Articular Cartilage
               OC Graft                           Lesions of the Knee, American Journal of
                                                  Sports Medicine, Dec. 1998

                                                                  C-00029.A 08/2006




                                                                                             9
Large Chondral Lesions
                                     1
             Lesion > 2 cm2
               (1.6 cm Diameter)


   Primary Treatment               Secondary
                                   Treatment


 Low-        High-                 Low / High
Demand      Demand                  Demand
                                                      Courtesy of Scott Gillogly, MD


Debride        ACI                  ACI         1
                                                 Cole & Farr, Operative Techniques in
MicroFx       Auto                  Allograft   Orthopaedics, April 2001
Auto          OC Graft                          1
                                                  Mandelbaum et al. Articular Cartilage
OC Graft                                        Lesions of the Knee, American Journal of
                                                Sports Medicine, Dec. 1998




                                                                  C-00029.A 08/2006




Carticel® History
   1987: First patients treated in Sweden
                                                                 et
   1994: Pilot study results (23 patients) published (Brittberg, et
   al. NEJM)
   1995: Carticel® (autologous cultured chondrocytes)
   launched, first patient treated in US
   1997: Genzyme receives biologic license (BLA) from FDA
   2000: 1st major publication with long-term outcomes
                                    long-
   (Peterson, et al. CORR)
   2004: 10,000th Carticel implant
   2005: CPT Code: 27412 / 10th Year Anniversary
                     Study-      post-
   2006: The STAR Study-a major post-approval commitment
   was submitted to the FDA

                                                                  C-00029.A 08/2006




Identifying a Carticel® Patient
Patient Factors:
 Younger patients –
 < age 45 - 50 (avg. ~ 35
  y.o.)
  Significant impairment:
      Compromised activities of
      daily living
      Refractory to treatment
  Weight - obesity
  Physical demands:
      Willing & capable of
      rehabilitation program
  No arthritis!
                                                                  C-00029.A 08/2006




                                                                                           10
 Identifying a Carticel® Patient

Joint Factors:
   Moderate to large (> 2cm2 d.= 1.6)
   symptomatic cartilage defects on
   the distal femur (MFC / LFC /
   Trochlea)
       Average defect size > 4 cm2
   Either chondral or osteochondral

   Relatively healthy joint
       No arthritis
   Co-
   Co-morbidities must be corrected
   prior or concurrent to implantation
      Meniscal tear, instability or                Courtesy of Scott Gillogly, MD
      malalignment

                                                                  C-00029.A 08/2006




              Pre-
 Implantation Pre-requisites

    Ligament stability (e.g. fix ACL tear)
    Mechanical alignment (e.g. “bowlegged”)
                                bowlegged”
    Functional meniscus
    Motion and muscle strength
    Defect:
        Isolated vs. multiple
        Size & location
        Degree of containment
    Bone status - OCD
                                                                  C-00029.A 08/2006




              Pre-
 Implantation Pre-requisites: Mechanical Axis

                   Xray”
   “Long Standing Xray”
   Here: Mechanical Axis is
   very medial to center of
   knee
          Legged”
   “Bow Legged” from
   cartilage damage




                            Courtesy of James York, MD
                                                                  C-00029.A 08/2006




                                                                                      11
             Pre-
Implantation Pre-requisites: Restore
Mechanical Axis
 “High Tibial Osteotomy”




       Courtesy of James York, MD
                                              C-00029.A 08/2006




   Joint Replacement Surgery


      For more extensive cartilage damage in
      relatively older people
       Usually over age 45 – 50
      Diffuse cartilage damage -- OA




                                              C-00029.A 08/2006




   ACI (Cartilage Transplant) Results

               80% good / excellent results
                    Much better function and much
                   less pain
               20% fair / poor results
                    Some pain and stiffness
                Low complications:
                     Excessive scarring – 2%;
                     Cartilage overgrowth – 2%;
                     Failure – 3%

                                              C-00029.A 08/2006




                                                                  12
ACI: two stages -

 1. Biopsy Procurement by
    scope
 2. Open Implantation 6 wk
    later


 •   Harvest from a non-
     weight bearing area




                                                          C-00029.A 08/2006




     ACI: Cartilage Biopsy – stage 1 done via
     arthroscopy




                             Courtesy of James York, MD
                                                          C-00029.A 08/2006




Stage 2: ACI, Defect Preparation
Excise all damaged or
unhealthy cartilage from
perimeter of the defect
Leave sharp, vertical walls of
healthy cartilage with smooth
edges
Bone bed should be intact and
free of scar and bleeding




                                                          C-00029.A 08/2006




                                                                              13
ACI: Defect Preparation




                               Courtesy of James York, MD
                                                            C-00029.A 08/2006




  ACI: Periosteum (Bone Membrane)
             Procurement

  Thin membrane covers all bone
  Carefully harvest a piece
  (similar to harvesting skin for
  grafting)




                                                            C-00029.A 08/2006




       ACI: Periosteum Fixation
Membrane is sewn over the
cartilage defect
Like sewing egg membrane to
chocolate
Space sutures 3-4mm apart to
achieve a water tight seal
Leave a superior opening for
cell injection




                                                            C-00029.A 08/2006




                                                                                14
           ACI: Periosteum Fixation




                               Courtesy of James York, MD
                                           C-00029.A 08/2006




               ACI: Watertight Testing
Inject sterile saline into
defect
Inspect for leakage
Use fibrin glue to assist in
achieving water tightness
Aspirate all remaining
saline from under the
periosteum




                                           C-00029.A 08/2006




          ACI: Implant Cartilage Cells

Resuspend cells in vial
with catheter
Insert catheter
Ensure even distribution
of cells
Close superior opening
with additional sutures
and fibrin glue



                                           C-00029.A 08/2006




                                                               15
        Patient’
Vial of Patient’s own Cultured Chondrocytes




                                                     C-00029.A 08/2006




Defects Repaired




                             Courtesy of James York, MD

                                                     C-00029.A 08/2006




 Long lasting cartilage repair




               Post Transplant - 36 months

                                                     C-00029.A 08/2006




                                                                         16
             Cartilage Healing Phases and
            Rehabilitation: repair consistency
 Cell Growth                 Cell Matrix                       Maturation
   Phase                     Remodeling




   Months 0-3                     Months 4-9                     Months 9-12
Fragile membrane                 Soft to more                     Approaches

  To “Gelatin”                        Firm                      Normal “dense

  consistency                 “Window Putty”                        Vinyl”
                                                                  consistency
                                                                       C-00029.A 08/2006




                 Cartilage Healing Phases and
                         Rehabilitation
 Cell Growth                 Cell Matrix                       Maturation
   Phase                     Remodeling




   Months 0-3                     Months 4-9                     Months 9-12
Non-weight bearing             Strengthening                     High Impact
    0- 2 weeks                                                  Sports / Heavy
                                 Low Impact
                                                                Occupational
Progressive weight              Sports / Light
                                                                  Activities
bearing 1-2 months              Occupational
                                  Activities
                                                                       C-00029.A 08/2006




     Suggested Reading

      Peterson et al. Autologous Chondrocyte Transplantation -
                                   Durability,
      Biomechanics and Long Term Durability, AJSM, Vol. 30, No. 1
         Case study series - established clinical & scientific basis
         61 patients, avg. F/U 7.4
         Subjective and objective assessments, including:
             Macro assessment
             Histology
             Mechanical indentation
      Browne et al. Clinical Outcome of Autologous Chondrocyte
                                    Subjects,
      Implantation at 5 Years in US Subjects, CORR No. 436 – 2005
         Multi-
         Multi-center series - Cartilage Repair Registry
         1st 100 consecutive patients treated w/ defect on the distal femur w/ min. F/U
         5-year
         Avg. size defect = 4.9 cm2
         Most patients failed prior treatment
         38% Workers Comp.

                                                                       C-00029.A 08/2006




                                                                                           17
Suggested Reading

  Mithofer et al. Articular Cartilage Repair with Autologous
                                        Players,
  Chondrocyte Implantation in Soccer Players, AJSM Vol. 33 No.
  11 – 2005
     Multi-                     high-
     Multi-center analysis of high-demand athletes treated with ACI
     45 Soccer players, avg. F/U ~ 41 months
     Activity and ability to return to activity
     Assessed factors influencing return to sport
  Fu et al. Autologous Chondrocyte Implantation vs. Debridement
                                                          Knee,
  for Treatment of Full Thickness Chondral Defects of the Knee,
  AJSM Vol 33 No. 11 – 2005
     Multi-
     Multi-center retrospective analysis – Cartilage Repair Registry
                                                                     (42)
     Comparing similar cohorts of patients treated with Debridement (42)
     and ACI (54)
     3-Year F/U

                                                             C-00029.A 08/2006




Indications

Carticel®
Carticel® is for autologous use and is indicated for the repair of
                                                                   lateral
symptomatic cartilage defects of the femoral condyle (medial, lateral or
trochlea), caused by acute or repetitive trauma, in patients who have had
an inadequate response to a prior arthroscopic or other surgical repair
                                                           cartilage
procedure. Carticel is not indicated for the treatment of cartilage damage
                                                          recommended
associated with generalized osteoarthritis, and it is not recommended for
patients with total meniscectomy unless surgically reconstructed prior to
or concurrent with Carticel implantation.




                                                             C-00029.A 08/2006




                 Thank You!



                                                             C-00029.A 08/2006




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