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SLAP & PASTA Lesions
                Alan M. Hirahara, M.D., FRCS(C)
       Board Certified in Orthopaedic Surgery & Orthopaedic Sports Medicine
                    Specializing in arthroscopic shoulder surgery




     Medical Director               Team Physician              Consultant
Sacramento State Athletics       Sacramento River Cats          Oakland A’s
                                      MiLB - AAA
SLAP LESIONS
SLAP Lesions
        • Superior (Top)

        • Labral

        • Anterior (Front)

        • Posterior (Back)




                   Maffet et al., Am J Sports Med, 1995; 23:93-98
MRI vs. MRA
MRI – 50% Sensitivity; MRA – 93% Sensitivity




                                   Rafii et al. Radiol Clin North Am 1998, 36: 609-633
Beware the Buford Complex
• 58 yo female with anterior shoulder pain since
   8/08, without trauma. Surgeon took her to
   surgery 2/2009 and performed “debridement
   of pRCT and Bankart repair.”
• Presented 6/2010 with significantly increased
   pain and limited Abd-ER
Beware the MGHL Band
SLAP Repair: PushLock
Enhancing SLAP repairs with
        Fibrin-PRP Clots
                             Alan M Hirahara, MD, FRCSC
                                   Kyle Yamashiro, PT
                                  Russ Dunning, MSPT



*Presented @ AANA, AOSSM, COA, WOA 2009
Study
• Case-Control study design
• 178 patients with SLAP repair with & without PRP
• Study group had statistically significant:
   –   Improved pain scores from 3 months & on
   –   Improved ASES scores from 1 month & on
   –   Improved time to discharge by 91 days
   –   Improved return to work by 59.4 days
   –   Improved failure rate from 10.3% (Control) to 0.7% (Study)


• Conclusion
   – PRP ensures the healing process is initiated properly where placed
Fixation Options
SLAP Repair: Suture Anchor
Knot Stacks
Knot Stacks
Knot Stacks




              Courtesy of Dr. Neal ElAttrache
Labral Deficiency

• 40 yo woman h/o superior
  labral resection

• c/o grinding with arm going
  above shoulder with severe,
  progressively worsening pain
Labral Sewing
Labral Reconstruction
   Labral Sewing
PASTA LESIONS
PASTA Lesions
Determining PASTA Size
         • Ellman et al – Normal cuff 10-12 mm thick
         • Nottage et al
                  – Exposed bone between cuff / articular margin = 1.7 mm
                  – If interval > 7 mm, then > 50% thickness tear
         • PASTA Depth Guide – Ian Lo




Ellman H, Clin Orthop 254:64-74, 1990.
Nottage W et al., AANA, Washington DC, 2002.
Determining PASTA Size
• “Shaver Method”
• Ultrasound
  – Smith et al. Clin Radiol. 2011 – Meta-analysis
     •   62 studies / 6066 shoulders
     •   Partial RCT Sensitivity 0.84 / Specificity 0.89
     •   Full RCT       Sensitivity 0.96 / Specificity 0.93
     •   Technician dependent
To Repair or Not To Repair?
          • > or < 50% - Classic indication(1-4)

          • Abrams: 25% - 50% - a questionable region? (5)




Ellman. Clin Orthop 254:64-74, 1990.
Gartsman et al. J Shoulder Elbow Surg 4:228-241. 1995.
Nottage et al. AANA, Washington DC, 2002.
Wright et al. J Shoulder Elbow Surg, 5:458-466, 1996.
Abrams. AAOS ICL, 2002.
Current Recommendation
• Romeo et al. Arthroscopy. 2011
   – Literature review – 16 studies
   – Excellent outcomes 28.7% - 93%
   – Debridement of pRCT < 50% -> Good/Excellent outcomes
      • Associated progression to fRCT = 6.5 – 34.6%

   – > 50% -> Excellent results
      • Using takedown, trans-tendon, or trans-osseous repairs
Repair Options
• Debridement
• “Complete the Tear”
• Trans-osseous suture arthroscopic repair (Tauber)
• Trans-tendon repair (Burkhart, Romeo, Snyder)
PASTA Repair: Trans-tendon
Traditional RC Techniques




        Anchor depth         Distal-lateral
        determines           fixation improves
        compression          compression


Suture anchor          Transosseous
Rationale for a New Technique
• Suture anchor technically challenging
• Couldn’t address broad Anterior-Posterior lesions
PASTA Bridge
• Combines a horizontal mattress & bridging style repair
• Does NOT require ANY arthroscopic knot tying
PASTA Bridge
• Combines a horizontal mattress & bridging style repair
• Does NOT require ANY arthroscopic knot tying
Pasta Bridge Technique
PASTA Bridge - A New Technique in
 PASTA Repairs: A Biomechanical
Evaluation of Construct Strength vs.
          Suture Anchors

                            Alan M Hirahara, MD, FRCSC




*Presented @ AANA, COA, WOA, WSTC-EFOST 2012
Study: Construct Strength
• 12 cadaveric shoulders (6 matched pairs)
• 50% thickness, 1 cm wide PASTA lesion created in each
  shoulder
• For each pair:
   – Titanium corkscrew anchor with single horizontal mattress
     repair
   – PASTA bridge repair – 2 – 2.4 BC ST & 1 – 4.5 VSL
• Load to Failure & Mode of Failure
PASTA Bridge: Construct Strength
      Comparison Study
                            SutureTak and SwiveLock PASTA Repair
                                    Ultimate Load
    Donor #        Gender    Age                                  Mode of Failure
                                         (N)
    10-09064          M       62        1637                    humeral head broke
    10-08024          M       27        1499                tendon tore mid-substance
    10-11021          F       53         811                   tendon tore at repair
    10-09062          F       52         899                    humeral head broke
    11-01032          M       46         402               muscle body tore from tendon
    10-10068          F       53         810               muscle body tore from tendon
            Average           49        1010
       Standard Deviation     12         468

                              Titanium Corkscrew PASTA Repair
                                    Ultimate Load
    Donor #        Gender    Age                                 Mode of Failure
                                         (N)
    10-09064          M      62         1398              muscle body tore from tendon
    10-08024          M      27         1642                  tendon tore at repair
    10-11021          F      53          922                  humeral head broke
    10-09062          F      52          969                  tendon tore at repair
    11-01032          M      46         1003              muscle body tore from tendon
    10-10068          F      53          575                  tendon tore at repair
            Average          49         1085
       Standard Deviation    12          378
PASTA Bridge – Methods of Failure
PASTA Bridge - A New
   Technique in PASTA Repairs:
       A Clinical Evaluation

                            Alan M Hirahara, MD, FRCSC




*Presented @ AANA, COA, WOA, WSTC-EFOST 2012
PASTA Bridge Clinical Study
          Preliminary Results
• Case-Control analysis of 76 patients
    – 50 study patients – PASTA Bridge repair
    – 26 control patients – Trans-tendon repair


• Inclusions: All PASTA repairs, > 25% thickness


• Exclusions: Any post-op trauma or non-compliance


• Failure to heal: Evaluated any symptoms 4-6 months post-op with repeat
   MRA or surgery
Results
                     Pain Scores                                          ASES Scores


8.0                                                  80.0

7.0                                                  70.0

6.0                                                  60.0

5.0                                                  50.0

4.0                                                  40.0

3.0                                                  30.0

2.0                                                  20.0

1.0                                                  10.0

0.0                                                   0.0
      Pre-op     1     2     3     4     5     6            Pre-op     1     2     3     4     5     6
               Month Month Month Month Month Month                   Month Month Month Month Month Month




                                         Control Group: n = 26
                                         Study Group: n = 50
Results - Failures
                 Failures

             4
 4
                               3
3.5

 3

2.5

 2

1.5

 1
          4/26              3/50
0.5

 0

         Control Group      Study Group
Conclusion
• No significant difference between groups
• Will require a randomized controlled trial


• Easy, percutaneous technique
• Minimal risk of damaging shoulder during surgery
• Proven biomechanical strength
Extension Bridge
Increased Concentration of White
 Blood Cells in PRP Weakens Rotator
 Cuff Tendons When Used for PASTA
                Repairs

                               Alan M Hirahara, MD, FRCSC




*Presented @ WOA 2011 & WSTC-EFOST 2012 / Accepted for Presentation @ AANA 2013
Study Design
• Case-Control study design


• 3 Groups
    – Group 1: 14 patients, PASTA repair without PRP
    – Group 2: 72 patients, PASTA repair with PRP with concentrated WBC’s
    – Group 3: 29 patients, PASTA repair with PRP with reduced WBC’s


• MRA or surgery was performed for people having persistent pain or
   complaints at four to six months post-operatively to evaluate healing
WBC’s: Harmful to Healing
          •        The inflammatory response can cause muscle damage
                     –      Neutrophils can delay regenerative healing capacity1
                     –      Neutrophils cause cytotoxic destruction of muscle2


          •        WBCs can suppress bone formation and bone healing
                     –      Neutropenic mice—higher bending moment at fracture callus site3
                     –      Immunosuppressed rats; implanted DBM had enhanced bone formation4


          •        Concentrated WBCs may be detrimental toward wound healing
                     –      Neutropenic mice had accelerated wound closure and healing5
                     –      PU.1 null mice (lack neutrophils and macrophages) repair wounds in a scar-free manner, similar to
                            embryonic healing6
                     –      Oral mucosa wounds heal fast without scarring—have reduced influx of neutrophils and macrophages7

1.   Toumi H et al. The inflammatory response: friend or enemy for muscle injury? Br J Sports Med 2003; 37(4): 284-6.
2.   Schneider BS et al. Neutrophil infiltration in exercise-injured skeletal muscle: how do we resolve the controversy? Sports Med 2007; 37(10): 837-56.
3.   Grogaard B et al. The polymorphonuclear leukocyte: has it a role in fracture healing? Arch Orthop Trauma Surg 1990; 109(5): 268-71.
4.   Voggenreiter G et al. Immunosuppression with FK506 increases bone induction in demineralized isogenic and xenogenic bone matrix in the rat. J Bone Miner Res 2000; 15(9): 1825-34.
5.   Dovi JV et al. Accelerated wound closure in neutrophil-depleted mice. J Leukoc Biol 2003; 73(4): 449-55.
6.   Martin P et al. Wound healing in the PU.1 null mouse—tissue repair is not dependent on inflammatory cells. Curr Biol 2003; 13(13): 1122-8.
7.   Szpaderka AM. Differential injury responses in oral mucosal and cutaneous wounds. J Dent Res 2003; 82(8): 621-6.
Study
• No significant difference in improvement of ASES &
  VAS scores
• Significant difference in Modes of Failure
   – Group 1: 2 (14%) fail by non-healing of primary lesion
   – Group 2: 10 (14%) fail by cut-through from sutures
      • 2 (3.5%) fail by non-healing of primary lesion
   – Group 3: 1 (3.5%) fail by different, new delamination tear
Study

• Conclusion
  – PRP aids healing of PASTA repairs

  – PRP with concentrated WBC’s may create a
    “Zone of Weakness”

  – Neutrophils most likely culprit
FlexiGraft DBM Sponge

• Partially demineralized cancellous sponges
  – Ground

  – Cubes

  – Strips

• Demineralized cortical fibers
Literature
• Re: Tendon-to-bone healing. “Increase in the strength of the
  interface … [is] proportional to the amount of osseous ingrowth.”
       • Rodeo, Arnoczky et al., JBJS(A) 1993;75: 1795–1803



• Improving the osteoconductive/inductive environment
  improves tendon-bone healing
       • Shen H, et al. Int Orthop. 2010;34;(6)917-24.
       • Hioki S, et al. Am J Sports Med. 2012;40;(8)1772-80.
       • Kadonishi Y, et al. JBJS(B). 2012;94;(2)205-9.
Literature

• DBM produced significantly more
  fibrocartilage & mineralized fibrocartilage
  at 12-week post-op, showing a more
  mature, organized tendon-bone interface
   – Sundar et al.
       • J Biomed Mater Res. 2009; 88B: 115-122
       • J Bone Joint Surg Br. 2009;91;(9)1257-62
Flexigraft – Clinical Effectiveness in
          Rotator Cuff Repairs

                               Alan M Hirahara, MD, FRCSC




*Presented @ North American Faculty Forum 2013
Study Design - PASTABridge
Study                               Control

• 7 patients                        • 35 patients
   – 6 male / 1 female                 – 15 male / 20 female

   – Age mean: 45.11 (27 – 67 yo)      – Age mean: 52.07 (22 – 80 yo)

• 2 revisions                       • 3 revisions
FlexiGraft – PASTA Bridge
PASTABridge
VAS             ASES



7.0             80.0

6.0             70.0

                60.0
5.0
                50.0
4.0
                40.0
3.0
                30.0
2.0
                20.0
1.0             10.0

0.0              0.0




         Study Group
         Control Group
Study Design - SutureBridge
Study                               Control

• 9 patients                        • 45 patients
   – 5 male / 4 female                 – 25 male / 20 female

   – Age mean: 61.61 (55 – 68 yo)      – Age mean: 56.64 (34 – 78 yo)

• 2 revisions                       • 9 revisions
FlexiGraft – SutureBridge
SutureBridge
VAS              ASES



9.0              80.0
8.0              70.0
7.0              60.0
6.0
                 50.0
5.0
                 40.0
4.0
                 30.0
3.0
2.0              20.0

1.0              10.0

0.0               0.0




          Study Group
          Control Group
Future Research
•   Investigator: James Cook, DVM, PhD, University of Missouri
•   Objective: To assess the effects of FlexiGraft for rotator cuff tendon-to-bone
    healing in a canine model of a chronic rotator cuff tear using MRI, biomechanical
    testing and histology.
•   Experimental design:
     – Chronic Infraspinatus canine model (n=10 dogs), bilateral shoulders (release tendon, wait 4
        weeks)
     – FlexiGraft+ACP vs. Direct Repair (n=10 shoulders per group)
     – SpeedFix Repair – SwiveLock and FiberTape
     – @ 12 weeks post-op
          •   MRI (n=10 dogs, 20 shoulders)
          •   Biomech testing (destructive, n=5 each group)
          •   Histo (n=5 each group)
Thank You!

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SLAP & PASTA Lesions 01-2013

  • 1. SLAP & PASTA Lesions Alan M. Hirahara, M.D., FRCS(C) Board Certified in Orthopaedic Surgery & Orthopaedic Sports Medicine Specializing in arthroscopic shoulder surgery Medical Director Team Physician Consultant Sacramento State Athletics Sacramento River Cats Oakland A’s MiLB - AAA
  • 3. SLAP Lesions • Superior (Top) • Labral • Anterior (Front) • Posterior (Back) Maffet et al., Am J Sports Med, 1995; 23:93-98
  • 4. MRI vs. MRA MRI – 50% Sensitivity; MRA – 93% Sensitivity Rafii et al. Radiol Clin North Am 1998, 36: 609-633
  • 5. Beware the Buford Complex • 58 yo female with anterior shoulder pain since 8/08, without trauma. Surgeon took her to surgery 2/2009 and performed “debridement of pRCT and Bankart repair.” • Presented 6/2010 with significantly increased pain and limited Abd-ER
  • 8. Enhancing SLAP repairs with Fibrin-PRP Clots Alan M Hirahara, MD, FRCSC Kyle Yamashiro, PT Russ Dunning, MSPT *Presented @ AANA, AOSSM, COA, WOA 2009
  • 9. Study • Case-Control study design • 178 patients with SLAP repair with & without PRP • Study group had statistically significant: – Improved pain scores from 3 months & on – Improved ASES scores from 1 month & on – Improved time to discharge by 91 days – Improved return to work by 59.4 days – Improved failure rate from 10.3% (Control) to 0.7% (Study) • Conclusion – PRP ensures the healing process is initiated properly where placed
  • 14. Knot Stacks Courtesy of Dr. Neal ElAttrache
  • 15. Labral Deficiency • 40 yo woman h/o superior labral resection • c/o grinding with arm going above shoulder with severe, progressively worsening pain
  • 17. Labral Reconstruction Labral Sewing
  • 20. Determining PASTA Size • Ellman et al – Normal cuff 10-12 mm thick • Nottage et al – Exposed bone between cuff / articular margin = 1.7 mm – If interval > 7 mm, then > 50% thickness tear • PASTA Depth Guide – Ian Lo Ellman H, Clin Orthop 254:64-74, 1990. Nottage W et al., AANA, Washington DC, 2002.
  • 21. Determining PASTA Size • “Shaver Method” • Ultrasound – Smith et al. Clin Radiol. 2011 – Meta-analysis • 62 studies / 6066 shoulders • Partial RCT Sensitivity 0.84 / Specificity 0.89 • Full RCT Sensitivity 0.96 / Specificity 0.93 • Technician dependent
  • 22. To Repair or Not To Repair? • > or < 50% - Classic indication(1-4) • Abrams: 25% - 50% - a questionable region? (5) Ellman. Clin Orthop 254:64-74, 1990. Gartsman et al. J Shoulder Elbow Surg 4:228-241. 1995. Nottage et al. AANA, Washington DC, 2002. Wright et al. J Shoulder Elbow Surg, 5:458-466, 1996. Abrams. AAOS ICL, 2002.
  • 23. Current Recommendation • Romeo et al. Arthroscopy. 2011 – Literature review – 16 studies – Excellent outcomes 28.7% - 93% – Debridement of pRCT < 50% -> Good/Excellent outcomes • Associated progression to fRCT = 6.5 – 34.6% – > 50% -> Excellent results • Using takedown, trans-tendon, or trans-osseous repairs
  • 24. Repair Options • Debridement • “Complete the Tear” • Trans-osseous suture arthroscopic repair (Tauber) • Trans-tendon repair (Burkhart, Romeo, Snyder)
  • 26. Traditional RC Techniques Anchor depth Distal-lateral determines fixation improves compression compression Suture anchor Transosseous
  • 27. Rationale for a New Technique • Suture anchor technically challenging • Couldn’t address broad Anterior-Posterior lesions
  • 28. PASTA Bridge • Combines a horizontal mattress & bridging style repair • Does NOT require ANY arthroscopic knot tying
  • 29. PASTA Bridge • Combines a horizontal mattress & bridging style repair • Does NOT require ANY arthroscopic knot tying
  • 31. PASTA Bridge - A New Technique in PASTA Repairs: A Biomechanical Evaluation of Construct Strength vs. Suture Anchors Alan M Hirahara, MD, FRCSC *Presented @ AANA, COA, WOA, WSTC-EFOST 2012
  • 32. Study: Construct Strength • 12 cadaveric shoulders (6 matched pairs) • 50% thickness, 1 cm wide PASTA lesion created in each shoulder • For each pair: – Titanium corkscrew anchor with single horizontal mattress repair – PASTA bridge repair – 2 – 2.4 BC ST & 1 – 4.5 VSL • Load to Failure & Mode of Failure
  • 33. PASTA Bridge: Construct Strength Comparison Study SutureTak and SwiveLock PASTA Repair Ultimate Load Donor # Gender Age Mode of Failure (N) 10-09064 M 62 1637 humeral head broke 10-08024 M 27 1499 tendon tore mid-substance 10-11021 F 53 811 tendon tore at repair 10-09062 F 52 899 humeral head broke 11-01032 M 46 402 muscle body tore from tendon 10-10068 F 53 810 muscle body tore from tendon Average 49 1010 Standard Deviation 12 468 Titanium Corkscrew PASTA Repair Ultimate Load Donor # Gender Age Mode of Failure (N) 10-09064 M 62 1398 muscle body tore from tendon 10-08024 M 27 1642 tendon tore at repair 10-11021 F 53 922 humeral head broke 10-09062 F 52 969 tendon tore at repair 11-01032 M 46 1003 muscle body tore from tendon 10-10068 F 53 575 tendon tore at repair Average 49 1085 Standard Deviation 12 378
  • 34. PASTA Bridge – Methods of Failure
  • 35. PASTA Bridge - A New Technique in PASTA Repairs: A Clinical Evaluation Alan M Hirahara, MD, FRCSC *Presented @ AANA, COA, WOA, WSTC-EFOST 2012
  • 36. PASTA Bridge Clinical Study Preliminary Results • Case-Control analysis of 76 patients – 50 study patients – PASTA Bridge repair – 26 control patients – Trans-tendon repair • Inclusions: All PASTA repairs, > 25% thickness • Exclusions: Any post-op trauma or non-compliance • Failure to heal: Evaluated any symptoms 4-6 months post-op with repeat MRA or surgery
  • 37. Results Pain Scores ASES Scores 8.0 80.0 7.0 70.0 6.0 60.0 5.0 50.0 4.0 40.0 3.0 30.0 2.0 20.0 1.0 10.0 0.0 0.0 Pre-op 1 2 3 4 5 6 Pre-op 1 2 3 4 5 6 Month Month Month Month Month Month Month Month Month Month Month Month  Control Group: n = 26  Study Group: n = 50
  • 38. Results - Failures Failures 4 4 3 3.5 3 2.5 2 1.5 1 4/26 3/50 0.5 0 Control Group Study Group
  • 39. Conclusion • No significant difference between groups • Will require a randomized controlled trial • Easy, percutaneous technique • Minimal risk of damaging shoulder during surgery • Proven biomechanical strength
  • 41. Increased Concentration of White Blood Cells in PRP Weakens Rotator Cuff Tendons When Used for PASTA Repairs Alan M Hirahara, MD, FRCSC *Presented @ WOA 2011 & WSTC-EFOST 2012 / Accepted for Presentation @ AANA 2013
  • 42. Study Design • Case-Control study design • 3 Groups – Group 1: 14 patients, PASTA repair without PRP – Group 2: 72 patients, PASTA repair with PRP with concentrated WBC’s – Group 3: 29 patients, PASTA repair with PRP with reduced WBC’s • MRA or surgery was performed for people having persistent pain or complaints at four to six months post-operatively to evaluate healing
  • 43. WBC’s: Harmful to Healing • The inflammatory response can cause muscle damage – Neutrophils can delay regenerative healing capacity1 – Neutrophils cause cytotoxic destruction of muscle2 • WBCs can suppress bone formation and bone healing – Neutropenic mice—higher bending moment at fracture callus site3 – Immunosuppressed rats; implanted DBM had enhanced bone formation4 • Concentrated WBCs may be detrimental toward wound healing – Neutropenic mice had accelerated wound closure and healing5 – PU.1 null mice (lack neutrophils and macrophages) repair wounds in a scar-free manner, similar to embryonic healing6 – Oral mucosa wounds heal fast without scarring—have reduced influx of neutrophils and macrophages7 1. Toumi H et al. The inflammatory response: friend or enemy for muscle injury? Br J Sports Med 2003; 37(4): 284-6. 2. Schneider BS et al. Neutrophil infiltration in exercise-injured skeletal muscle: how do we resolve the controversy? Sports Med 2007; 37(10): 837-56. 3. Grogaard B et al. The polymorphonuclear leukocyte: has it a role in fracture healing? Arch Orthop Trauma Surg 1990; 109(5): 268-71. 4. Voggenreiter G et al. Immunosuppression with FK506 increases bone induction in demineralized isogenic and xenogenic bone matrix in the rat. J Bone Miner Res 2000; 15(9): 1825-34. 5. Dovi JV et al. Accelerated wound closure in neutrophil-depleted mice. J Leukoc Biol 2003; 73(4): 449-55. 6. Martin P et al. Wound healing in the PU.1 null mouse—tissue repair is not dependent on inflammatory cells. Curr Biol 2003; 13(13): 1122-8. 7. Szpaderka AM. Differential injury responses in oral mucosal and cutaneous wounds. J Dent Res 2003; 82(8): 621-6.
  • 44. Study • No significant difference in improvement of ASES & VAS scores • Significant difference in Modes of Failure – Group 1: 2 (14%) fail by non-healing of primary lesion – Group 2: 10 (14%) fail by cut-through from sutures • 2 (3.5%) fail by non-healing of primary lesion – Group 3: 1 (3.5%) fail by different, new delamination tear
  • 45. Study • Conclusion – PRP aids healing of PASTA repairs – PRP with concentrated WBC’s may create a “Zone of Weakness” – Neutrophils most likely culprit
  • 46. FlexiGraft DBM Sponge • Partially demineralized cancellous sponges – Ground – Cubes – Strips • Demineralized cortical fibers
  • 47. Literature • Re: Tendon-to-bone healing. “Increase in the strength of the interface … [is] proportional to the amount of osseous ingrowth.” • Rodeo, Arnoczky et al., JBJS(A) 1993;75: 1795–1803 • Improving the osteoconductive/inductive environment improves tendon-bone healing • Shen H, et al. Int Orthop. 2010;34;(6)917-24. • Hioki S, et al. Am J Sports Med. 2012;40;(8)1772-80. • Kadonishi Y, et al. JBJS(B). 2012;94;(2)205-9.
  • 48. Literature • DBM produced significantly more fibrocartilage & mineralized fibrocartilage at 12-week post-op, showing a more mature, organized tendon-bone interface – Sundar et al. • J Biomed Mater Res. 2009; 88B: 115-122 • J Bone Joint Surg Br. 2009;91;(9)1257-62
  • 49. Flexigraft – Clinical Effectiveness in Rotator Cuff Repairs Alan M Hirahara, MD, FRCSC *Presented @ North American Faculty Forum 2013
  • 50. Study Design - PASTABridge Study Control • 7 patients • 35 patients – 6 male / 1 female – 15 male / 20 female – Age mean: 45.11 (27 – 67 yo) – Age mean: 52.07 (22 – 80 yo) • 2 revisions • 3 revisions
  • 52. PASTABridge VAS ASES 7.0 80.0 6.0 70.0 60.0 5.0 50.0 4.0 40.0 3.0 30.0 2.0 20.0 1.0 10.0 0.0 0.0  Study Group  Control Group
  • 53. Study Design - SutureBridge Study Control • 9 patients • 45 patients – 5 male / 4 female – 25 male / 20 female – Age mean: 61.61 (55 – 68 yo) – Age mean: 56.64 (34 – 78 yo) • 2 revisions • 9 revisions
  • 55. SutureBridge VAS ASES 9.0 80.0 8.0 70.0 7.0 60.0 6.0 50.0 5.0 40.0 4.0 30.0 3.0 2.0 20.0 1.0 10.0 0.0 0.0  Study Group  Control Group
  • 56. Future Research • Investigator: James Cook, DVM, PhD, University of Missouri • Objective: To assess the effects of FlexiGraft for rotator cuff tendon-to-bone healing in a canine model of a chronic rotator cuff tear using MRI, biomechanical testing and histology. • Experimental design: – Chronic Infraspinatus canine model (n=10 dogs), bilateral shoulders (release tendon, wait 4 weeks) – FlexiGraft+ACP vs. Direct Repair (n=10 shoulders per group) – SpeedFix Repair – SwiveLock and FiberTape – @ 12 weeks post-op • MRI (n=10 dogs, 20 shoulders) • Biomech testing (destructive, n=5 each group) • Histo (n=5 each group)