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Patches for Rotator
   Cuff surgery
        Fraser Taylor
    Wrightington Hospital
Whats the Problem?
•   Rotator cuff tear is a common
    problem

•   Failure rates of repair vary
    from 10-90% !!

•   Traditional solutions have
    focused on improving
    mechanical factors

•   Interest now in biological
    solutions
Sutures                  PRP

Anchors                Patches            Stem cells

                                 Growth factors
   single vs double?



             Mechanical vs Biological
What do they do

• Aim to provide Mechanical Augmentation
• or
• Tendon replacement / interposition
• and
• Improve rate and quality of Biologic Healing
Challenges for a Rotator
  Cuff Replacement Graft

• Scaffold must rapidly attach to the stump of
  the rotator cuff and surrounding tissues
• Attach Firmly to bone
• Attract and support appropriate cells

                                Alex Castagna
Cuff Patches




                        Extracellular Matrices,
Synthetics
                                ECMs
Cuff Patches




                        Extracellular Matrices,
Synthetics
                                ECMs
Teflon patch
Synthetic Patches
 SportMesh
                Poly(urethaneure
 Soft Tissue
                       a)
Reinforcement

  X-Repair       Poly-L-lactide

                 Polycarbonate
Biomerix RCR
                poly(urethaneure
    Patch
                       a)
Well designed animal study
Improved strength, stiffness, ultimate load of repair.
         Increased cross sectional area
         Biocompatable (canine model)

           No clinical results
No website developments since sept 2010
• Ten patients, supraspinatus tears
        • open RCR
        • augmented with a polycarbonate
            polyurethane patch
        • 10% retear at one year
        • No reactions, well tolerated
Rotator cuff repair augmentation using a novel polycarbonate polyurethane patch: preliminary results at
                                         12 months’ follow-up
                                  Ivan Encalada-Diaz et al JSES 2011
Cuff Patches




                        Extracellular Matrices,
Synthetics
                                ECMs
Cuff Patches




                        Extracellular Matrices,
Synthetics
                                ECMs
Cuff Patches




                        Extracellular Matrices,
Synthetics
                                ECMs




                     Xenograft       Allograft
Cuff Patches



Synthetics             Extracellular Matrices,
                               ECMs




                     Xenograft      Allograft
Small intestine
    Restore                        Porcine       De Puy
                  Submucosa
                 Small intestine
   Cuff Patch                      Porcine    Organogenesis
                  Submucosa
  Graftjacket       Dermis         Human     Wright Medical
  ArthroFlex        Dermis         Human         Arthrex
    Conexa          Dermis         Porcine       Tornier
  TissueMend     Dermis (fetal)    Bovine        Stryker
Zimmer Collagen    Dermis
                                   Porcine       Zimmer
     Repair     (Cross-linked)
                   Dermis
  Bio-Blanket                      Bovine      Kensey Nash
                (Cross-linked)
  OrthADAPT      Pericardium
                                   Equine    Pegasus Biologics
   Bioimplant   (Cross-linked)
Small intestine
    Restore                        Porcine       De Puy
                  Submucosa
                 Small intestine
   Cuff Patch                      Porcine    Organogenesis
                  Submucosa
  Graftjacket       Dermis         Human     Wright Medical
  ArthroFlex        Dermis         Human         Arthrex
    Conexa          Dermis         Porcine       Tornier
  TissueMend     Dermis (fetal)    Bovine        Stryker
Zimmer Collagen    Dermis
                                   Porcine       Zimmer
     Repair     (Cross-linked)
                   Dermis
  Bio-Blanket                      Bovine      Kensey Nash
                (Cross-linked)
  OrthADAPT      Pericardium
                                   Equine    Pegasus Biologics
   Bioimplant   (Cross-linked)
Small intestine
    Restore                        Porcine       De Puy
                  Submucosa
                 Small intestine
   Cuff Patch                      Porcine    Organogenesis
                  Submucosa
  Graftjacket       Dermis         Human     Wright Medical
  ArthroFlex        Dermis         Human         Arthrex
    Conexa          Dermis         Porcine       Tournier
  TissueMend     Dermis (fetal)    Bovine        Stryker
Zimmer Collagen    Dermis
                                   Porcine       Zimmer
     Repair     (Cross-linked)
                   Dermis
  Bio-Blanket                      Bovine      Kensey Nash
                (Cross-linked)
  OrthADAPT      Pericardium
                                   Equine    Pegasus Biologics
   Bioimplant   (Cross-linked)
Small intestine
    Restore                        Porcine
                  Submucosa
                 Small intestine
   Cuff Patch                      Porcine    Organogenesis
                  Submucosa
  Graftjacket       Dermis         Human
  ArthroFlex        Dermis         Human
    Conexa          Dermis         Porcine
  TissueMend     Dermis (fetal)    Bovine
Zimmer Collagen    Dermis
                                   Porcine
     Repair     (Cross-linked)
                   Dermis
  Bio-Blanket                      Bovine      Kensey Nash
                (Cross-linked)
  OrthADAPT      Pericardium
                                   Equine    Pegasus Biologics
   Bioimplant   (Cross-linked)
(non x linked, porcine
       submucosa)

 Promising results in Canine
          studies.

Minimal inflammatory problems
(non x linked, porcine, small intestine submucosa)

•    Metcalf 2002 Op Tech Orth

•    2 year follow up 12 patients Arthroscopic Augmentation
     of Massive Tear Repair

•    No local or systemic rejection or infection

•    Functional improvement Simple Shoulder Test

•    UCLA score improved 9.9 to 19.9 /35

•    1 Failure and complete resorption within 12 weeks
      Surgical technique for xenograft (SIS) augmentation of rotator-cuff repairs.
    M.H. Metcalf, F.H. Savoie III, B. Kellum .Oper Tech Orthop, 12 (2002), pp. 204–208
(non x linked, porcine, small intestine submucosa)

     •    Sclamberg JSES 2004

     •    6 month MRI Follow up Large/ Massive tears

     •    4 Augmentation cases

     •    7 Interpositional Cases

     •    10/11 Failed on MRI

     •    No difference in shoulder scores (5 patients worse!)
Six-month magnetic resonance imaging follow-up of large and massive rotator cuff repairs reinforced
                              with porcine small intestinal submucosa.
Sclamberg SG, Tibone JE, Itamura JM, Kasraeian S. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):538-41.
(non x linked, porcine, small intestine submucosa)

       •    Iannotti JBJS am 2006

       •    30 Pt Randomised Controlled Trial

       •    Augmentation of Repairable large and massive 2 tendon
            repairs

       •    7% more likely to heal if Non Augmented!!!

       •    Penn Scores better in Non Augmented

       •    3/15 Augmented Patients sterile Inflammatory Reaction
Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff
                                   tears. A randomized, controlled trial
  J.P. Iannotti, M.J. Codsi,Y.W. Kwon, K. Derwin, J. Ciccone, J.J. Brems JBJS Am, 88 (2006),. 1238–1244
(non x linked, porcine, small intestine submucosa)



•   No benefit

•   Concerns regarding Oedema, swelling, pain and
    increased temperature.

•   Negative Microbial tests


•   Currently not recommended (AAOS)
(non-crosslinked Human Dermis)


  GJA is a freeze-dried acellular
     human dermal matrix.
Patented processing
  technology preserves this
biochemical matrix and results
in an extracellular framework
   that is completely intact.

 This intact matrix, complete
   with preserved vascular
channels, functions to support
  rapid revascularization and
     cellular repopulation.
(non-crosslinked Human Dermis)

         •    Burkhead, et al. 2007

         •    17 massive tears , 1 year follow up

         •    Open repair and augmentation

         •    UCLA scores improved from 9 to 26 (35)

         •    3 radiological failures of 12 patients scanned

         •    No reversal of Fatty infiltration, Muscle atrophy

         •    No infections or reactions
           Use of Graft Jacket as an Augmentation for Massive Rotator Cuff Tears
Wayne Z. Burkhead Jr. Shadley C. Schiffern, Sumant G. Krishnan, Seminars in Arthroplasty 2007
(non-crosslinked Human Dermis)

   •    Bond, Arthroscopy 2008

   •    Arthroscopic Interposition massive tears

   •    14/16 previous repair attempted

   •    15/16 Patients Satisfied at 27 months

   •    UCLA scores improved from 18 to 30

   •    Constant Score improved from 54 to 84

   •    13 Patients full graft incorporation on MRI
Arthroscopic replacement of massive, irreparable rotator cuff tears using a GraftJacket
                    allograft: technique and preliminary results.
        Bond JL, Dopirak RM, Higgins J, Burns J, Snyder SJ. Arthroscopy. 2008
(non-crosslinked Human Dermis)

• Wong, Snyder JSES 2010
• 45 pts Arthroscopic treatment
• Follow up to 2 years
• UCLA scores improved 18 to 28
• WORC 75 ASES 84
• Claimed good results with no bridges burned
              Arthroscopic GraftJacket repair of rotator cuff tears.
   Wong I, Burns J, Snyder S. J Shoulder Elbow Surg. 2010 Mar;19(2 Suppl):104-9.
(non-crosslinked Human Dermis)

      •    Barber 2012
      •    Prospective Randomised Trial 42 patients
      •    Augmentation of Arthroscopic 2 tendon repairs vs
           standard repair
      •    Augmentation gave better Constant and ASES scores
      •    Healing rate on MR Arthrogram 85% vs 40%
      •    No adverse events
   A Prospective, Randomized Evaluation of Acellular Human Dermal Matrix Augmentation for
                                  Arthroscopic Rotator Cuff Repair.
FA Barber, JP. Burns, A Deutsch, MR. Labbé, RB. Litchfield,Arthroscopy:Vol 28, Issue 1, Jan 2012, 8-15
(non-crosslinked Human Dermis)

• All studies on massive tears.
• Augmentation and interposition.
• No complications
• Improved Outcomes
• No control groups
• ??one to watch??
(Non crosslinked Human dermis)


      • Arthroscopic Reinforcement of RCR
      • Large, massive, prev repaired tears
      • 14 patients 2.5 to 6cm tears
      • MRI repair intact in 86% at 17 months
      • Constant score 50 to 81
      • Safe and effective technique
Healing rates for challenging rotator cuff tears utilizing an acellular human dermal reinforcement graft.
                                  Agrawal V. Int J Shoulder Surg. 2012
(Cross linked Porcine dermis)

         • Badhe JSES 2008 ( Derby)
         • 4.5 year follow up on 10 pts
         • Augmented repair
         • MRI and USS - 2 failures
         • Improved pain, strength, ROM
         • Constant improved 41 to 62
An assessment of porcine dermal xenograft as an augmentation graft in the treatment of extensive
                                      rotator cuff tears.
        Badhe SP, Lawrence TM, Smith FD, Lunn PG. J Shoulder Elbow Surg. 2008 Jan-Feb;
(Cross linked Porcine dermis)


       • Soler. Acta Orthop Belg 2007
       • Bridging device, interposition graft
       • 4 Patients
       • All failed between 3 to 6 months
Early complications from the use of porcine dermal collagen implants (Permacol) as bridging
         constructs in the repair of massive rotator cuff tears. A report of 4 cases.
          Soler JA, Gidwani S, Curtis MJ. Acta Orthop Belg. 2007 Aug;73(4):432-6.
Text
 Text
Scotts Parabola
Synthetic Patches
Extra Cellular Matrices
Summary

• Definite Paucity of Clinical studies
• Animal studies available
• Has been “one to watch” for last 15 years
Thank you

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Rotator cuff patches literature review 2012 - fraser taylor

  • 1. Patches for Rotator Cuff surgery Fraser Taylor Wrightington Hospital
  • 2. Whats the Problem? • Rotator cuff tear is a common problem • Failure rates of repair vary from 10-90% !! • Traditional solutions have focused on improving mechanical factors • Interest now in biological solutions
  • 3. Sutures PRP Anchors Patches Stem cells Growth factors single vs double? Mechanical vs Biological
  • 4. What do they do • Aim to provide Mechanical Augmentation • or • Tendon replacement / interposition • and • Improve rate and quality of Biologic Healing
  • 5. Challenges for a Rotator Cuff Replacement Graft • Scaffold must rapidly attach to the stump of the rotator cuff and surrounding tissues • Attach Firmly to bone • Attract and support appropriate cells Alex Castagna
  • 6. Cuff Patches Extracellular Matrices, Synthetics ECMs
  • 7. Cuff Patches Extracellular Matrices, Synthetics ECMs
  • 9. Synthetic Patches SportMesh Poly(urethaneure Soft Tissue a) Reinforcement X-Repair Poly-L-lactide Polycarbonate Biomerix RCR poly(urethaneure Patch a)
  • 10.
  • 11.
  • 12.
  • 13.
  • 14. Well designed animal study Improved strength, stiffness, ultimate load of repair. Increased cross sectional area Biocompatable (canine model) No clinical results No website developments since sept 2010
  • 15.
  • 16.
  • 17. • Ten patients, supraspinatus tears • open RCR • augmented with a polycarbonate polyurethane patch • 10% retear at one year • No reactions, well tolerated Rotator cuff repair augmentation using a novel polycarbonate polyurethane patch: preliminary results at 12 months’ follow-up Ivan Encalada-Diaz et al JSES 2011
  • 18. Cuff Patches Extracellular Matrices, Synthetics ECMs
  • 19. Cuff Patches Extracellular Matrices, Synthetics ECMs
  • 20. Cuff Patches Extracellular Matrices, Synthetics ECMs Xenograft Allograft
  • 21. Cuff Patches Synthetics Extracellular Matrices, ECMs Xenograft Allograft
  • 22. Small intestine Restore Porcine De Puy Submucosa Small intestine Cuff Patch Porcine Organogenesis Submucosa Graftjacket Dermis Human Wright Medical ArthroFlex Dermis Human Arthrex Conexa Dermis Porcine Tornier TissueMend Dermis (fetal) Bovine Stryker Zimmer Collagen Dermis Porcine Zimmer Repair (Cross-linked) Dermis Bio-Blanket Bovine Kensey Nash (Cross-linked) OrthADAPT Pericardium Equine Pegasus Biologics Bioimplant (Cross-linked)
  • 23. Small intestine Restore Porcine De Puy Submucosa Small intestine Cuff Patch Porcine Organogenesis Submucosa Graftjacket Dermis Human Wright Medical ArthroFlex Dermis Human Arthrex Conexa Dermis Porcine Tornier TissueMend Dermis (fetal) Bovine Stryker Zimmer Collagen Dermis Porcine Zimmer Repair (Cross-linked) Dermis Bio-Blanket Bovine Kensey Nash (Cross-linked) OrthADAPT Pericardium Equine Pegasus Biologics Bioimplant (Cross-linked)
  • 24. Small intestine Restore Porcine De Puy Submucosa Small intestine Cuff Patch Porcine Organogenesis Submucosa Graftjacket Dermis Human Wright Medical ArthroFlex Dermis Human Arthrex Conexa Dermis Porcine Tournier TissueMend Dermis (fetal) Bovine Stryker Zimmer Collagen Dermis Porcine Zimmer Repair (Cross-linked) Dermis Bio-Blanket Bovine Kensey Nash (Cross-linked) OrthADAPT Pericardium Equine Pegasus Biologics Bioimplant (Cross-linked)
  • 25. Small intestine Restore Porcine Submucosa Small intestine Cuff Patch Porcine Organogenesis Submucosa Graftjacket Dermis Human ArthroFlex Dermis Human Conexa Dermis Porcine TissueMend Dermis (fetal) Bovine Zimmer Collagen Dermis Porcine Repair (Cross-linked) Dermis Bio-Blanket Bovine Kensey Nash (Cross-linked) OrthADAPT Pericardium Equine Pegasus Biologics Bioimplant (Cross-linked)
  • 26. (non x linked, porcine submucosa) Promising results in Canine studies. Minimal inflammatory problems
  • 27. (non x linked, porcine, small intestine submucosa) • Metcalf 2002 Op Tech Orth • 2 year follow up 12 patients Arthroscopic Augmentation of Massive Tear Repair • No local or systemic rejection or infection • Functional improvement Simple Shoulder Test • UCLA score improved 9.9 to 19.9 /35 • 1 Failure and complete resorption within 12 weeks Surgical technique for xenograft (SIS) augmentation of rotator-cuff repairs. M.H. Metcalf, F.H. Savoie III, B. Kellum .Oper Tech Orthop, 12 (2002), pp. 204–208
  • 28. (non x linked, porcine, small intestine submucosa) • Sclamberg JSES 2004 • 6 month MRI Follow up Large/ Massive tears • 4 Augmentation cases • 7 Interpositional Cases • 10/11 Failed on MRI • No difference in shoulder scores (5 patients worse!) Six-month magnetic resonance imaging follow-up of large and massive rotator cuff repairs reinforced with porcine small intestinal submucosa. Sclamberg SG, Tibone JE, Itamura JM, Kasraeian S. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):538-41.
  • 29. (non x linked, porcine, small intestine submucosa) • Iannotti JBJS am 2006 • 30 Pt Randomised Controlled Trial • Augmentation of Repairable large and massive 2 tendon repairs • 7% more likely to heal if Non Augmented!!! • Penn Scores better in Non Augmented • 3/15 Augmented Patients sterile Inflammatory Reaction Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff tears. A randomized, controlled trial J.P. Iannotti, M.J. Codsi,Y.W. Kwon, K. Derwin, J. Ciccone, J.J. Brems JBJS Am, 88 (2006),. 1238–1244
  • 30. (non x linked, porcine, small intestine submucosa) • No benefit • Concerns regarding Oedema, swelling, pain and increased temperature. • Negative Microbial tests • Currently not recommended (AAOS)
  • 31. (non-crosslinked Human Dermis) GJA is a freeze-dried acellular human dermal matrix.
  • 32. Patented processing technology preserves this biochemical matrix and results in an extracellular framework that is completely intact. This intact matrix, complete with preserved vascular channels, functions to support rapid revascularization and cellular repopulation.
  • 33. (non-crosslinked Human Dermis) • Burkhead, et al. 2007 • 17 massive tears , 1 year follow up • Open repair and augmentation • UCLA scores improved from 9 to 26 (35) • 3 radiological failures of 12 patients scanned • No reversal of Fatty infiltration, Muscle atrophy • No infections or reactions Use of Graft Jacket as an Augmentation for Massive Rotator Cuff Tears Wayne Z. Burkhead Jr. Shadley C. Schiffern, Sumant G. Krishnan, Seminars in Arthroplasty 2007
  • 34. (non-crosslinked Human Dermis) • Bond, Arthroscopy 2008 • Arthroscopic Interposition massive tears • 14/16 previous repair attempted • 15/16 Patients Satisfied at 27 months • UCLA scores improved from 18 to 30 • Constant Score improved from 54 to 84 • 13 Patients full graft incorporation on MRI Arthroscopic replacement of massive, irreparable rotator cuff tears using a GraftJacket allograft: technique and preliminary results. Bond JL, Dopirak RM, Higgins J, Burns J, Snyder SJ. Arthroscopy. 2008
  • 35. (non-crosslinked Human Dermis) • Wong, Snyder JSES 2010 • 45 pts Arthroscopic treatment • Follow up to 2 years • UCLA scores improved 18 to 28 • WORC 75 ASES 84 • Claimed good results with no bridges burned Arthroscopic GraftJacket repair of rotator cuff tears. Wong I, Burns J, Snyder S. J Shoulder Elbow Surg. 2010 Mar;19(2 Suppl):104-9.
  • 36. (non-crosslinked Human Dermis) • Barber 2012 • Prospective Randomised Trial 42 patients • Augmentation of Arthroscopic 2 tendon repairs vs standard repair • Augmentation gave better Constant and ASES scores • Healing rate on MR Arthrogram 85% vs 40% • No adverse events A Prospective, Randomized Evaluation of Acellular Human Dermal Matrix Augmentation for Arthroscopic Rotator Cuff Repair. FA Barber, JP. Burns, A Deutsch, MR. Labbé, RB. Litchfield,Arthroscopy:Vol 28, Issue 1, Jan 2012, 8-15
  • 37. (non-crosslinked Human Dermis) • All studies on massive tears. • Augmentation and interposition. • No complications • Improved Outcomes • No control groups • ??one to watch??
  • 38. (Non crosslinked Human dermis) • Arthroscopic Reinforcement of RCR • Large, massive, prev repaired tears • 14 patients 2.5 to 6cm tears • MRI repair intact in 86% at 17 months • Constant score 50 to 81 • Safe and effective technique Healing rates for challenging rotator cuff tears utilizing an acellular human dermal reinforcement graft. Agrawal V. Int J Shoulder Surg. 2012
  • 39. (Cross linked Porcine dermis) • Badhe JSES 2008 ( Derby) • 4.5 year follow up on 10 pts • Augmented repair • MRI and USS - 2 failures • Improved pain, strength, ROM • Constant improved 41 to 62 An assessment of porcine dermal xenograft as an augmentation graft in the treatment of extensive rotator cuff tears. Badhe SP, Lawrence TM, Smith FD, Lunn PG. J Shoulder Elbow Surg. 2008 Jan-Feb;
  • 40. (Cross linked Porcine dermis) • Soler. Acta Orthop Belg 2007 • Bridging device, interposition graft • 4 Patients • All failed between 3 to 6 months Early complications from the use of porcine dermal collagen implants (Permacol) as bridging constructs in the repair of massive rotator cuff tears. A report of 4 cases. Soler JA, Gidwani S, Curtis MJ. Acta Orthop Belg. 2007 Aug;73(4):432-6.
  • 45. Summary • Definite Paucity of Clinical studies • Animal studies available • Has been “one to watch” for last 15 years

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