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PASTA Bridge - A New Technique in PASTA
   Repairs: A Biomechanical & Clinical
               Evaluation
                Alan M. Hirahara, M.D., FRCS(C)
                               Private Practice
                             Sacramento, CA USA




     Medical Director             Team Physician       Consultant
Sacramento State Athletics     Sacramento River Cats   Oakland A’s
                                    MiLB - AAA
BIOMECHANICAL EVALUATION
Objective of Study
• To evaluate the biomechanical strength & clinical
  effectiveness of a new PASTA repair technique – PASTA
  Bridge


• To introduce a novel technique in PASTA repair that is
  significantly easier, carries less risk, does not require
  arthroscopic knot tying, and is as effective as current trans-
  tendon techniques
Introduction
• In the literature, PASTA lesions can cause significant
  pain for patients


• Debridement alone of tears < 50% thickness can result in
  good/excellent outcomes but can progress on to full
  thickness tears (6.5-34.6%)


• Current repair techniques can lead to excellent results
  but are technically challenging
                                               Romeo et al. Arthroscopy 2011; 27(4): 568-80.
Study Design - Biomechanical

• Case-control study


• Six matched pairs of fresh frozed cadaver
  shoulders
  – 3 male / 3 female

  – Average age = 49 ± 12 years
Study Design
• For each sample, a partial tear of supraspinatus tendon was
  replicated by using a sharp blade to transect 50% of the medial
  side of supraspinatus from tuberosity 1 cm wide
• From each matched pair, one humerus selected to receive a PASTA
  repair using one 4.5mm titanium Corkscrew FT
• Contralateral repair done using a PASTA Bridge repair
• Half of the samples of each repair were performed on the right
  humeri to avoid a mechanical bias
• All repairs performed by an orthopaedic surgeon
Study Design

• Biomechanical testing conducted using an INSTON 8871 Axial Table Top
   Servohydraulic Testing System, with a 5kN load cell attached to cross-
   head
• System calibrated using FastTrack software, and load & position controls
   run through WaveMaker software
• Each sample positioned on a fixed angle fixture & secured to testing
   surface so direction of pull performed 45° to humeral shaft
• Custom fixture with inter-digitated brass clamps attached to cross-head,
   and dry ice was used to freeze the tendon to the clamp
Study Design

• For each sample, we determined
  – Ultimate load, yield load, and stiffness
  – Cyclic displacement and strain of each sample at both
    the articular margin and at the repair site
  – Paired t-tests (α = 0.05) to determine if differences in
    ultimate load or strain between the two repairs were
    significant
Pasta Bridge Technique
PASTA Bridge: Construct Strength
        Comparison Study
                                         SutureTak and SwiveLock PASTA Repair
                        Ultimate   Yield Stiffness Displacement (mm) Strain (mm/mm)
Donor # Side Gender Age                                                                        Mode of Failure
                        Load (N) Load (N) (N/mm) Repair Margin           Repair Margin
10-09064 R       M   62   1637     1637      144       0.12     0.12      1.015  1.009       humeral head broke
10-08024 L       M   27   1499     1308      136       0.52     0.21      1.056  1.014    tendon tore mid-substance
10-11021 R       F   53    811      811       65       0.29     0.63      1.041  1.043       tendon tore at repair
10-09062 R       F   52    899      899       61       0.63     0.44      1.177  1.048       humeral head broke
11-01032 L       M   46    402      402       74       0.78     0.36      1.133  1.027   muscle body tore from tendon
10-10068 L       F   53    810      660       81       0.48     0.21      1.062  1.016   muscle body tore from tendon
      Average        49   1010      953       94       0.47     0.33      1.081  1.026
 Standard Deviation 12     468      449       37       0.24     0.19      0.061  0.016
                                          Titanium Corkscrew PASTA Repair
                        Ultimate   Yield Stiffness Displacement (mm) Strain (mm/mm)
Donor # Side Gender Age                                                                        Mode of Failure
                        Load (N) Load (N) (N/mm) Repair Margin         Repair  Margin
10-09064 L       M   62   1398     1395      112      0.24     0.22     1.026   1.013    muscle body tore from tendon
10-08024 R       M   27   1642     1642      122      0.14     0.36     1.024   1.022        tendon tore at repair
10-11021 L       F   53    922      922       58      0.37     0.53     1.091   1.033        humeral head broke
10-09062 L       F   52    969      969      132      0.34     0.54     1.052   1.041        tendon tore at repair
11-01032 R       M   46   1003     1003       88      0.58     0.27     1.094   1.021    muscle body tore from tendon
10-10068 R       F   53    575      575       82      0.27     0.49     1.050   1.034        tendon tore at repair
      Average        49   1085     1084       99      0.32     0.40     1.056   1.027
 Standard Deviation 12     378      378       28      0.15     0.14     0.030   0.010
PASTA Bridge – Methods of Failure
Results

• No significant difference in the two groups in
  all parameters

• Mode of failure was always biological, not
  mechanical
Discussion
• Despite using smaller anchors, we have created a
  sturdy, reliable, easy, percutaneous repair
  technique that is just as strong as conventional
  larger suture anchor repairs
• Minimal risk of damaging shoulder during
  surgery
• Proven biomechanical strength
CLINICAL EVALUATION
Study Design - Clinical

• Case-control study


• Collection period: 8/09 – 12/11


• Pain scores, ASES scores taken every month for 6
  months
   – ROM measured pre-op and monthly for 3 months post
   – Date of discharge and date of return to work were noted
Study Design
• All patients requiring a PASTA repair
• Inclusions:
    – PASTA lesion > 25% thickness
• Exclusions:
    – any post-operative trauma
    – non-compliance with physical therapy protocol
• Failure to heal:
    – Evaluated any symptoms 4-6 months post-op with repeat MRA or
      surgery
Patient Data
Study Group                  Control Group


• 35 patients                • 26 patients

• 15 male / 20 female        • 12 male / 14 female

• Age range: 22 – 80 years   • Age range: 17 – 72 years

• Age average: 52.07 years   • Age average: 47.75 years
Results
                     Pain Scores                                          ASES Scores
                            p = NS                                               p = NS

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
      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 = 35
Range of Motion
          160.0


          140.0


          120.0


          100.0
                                                                              Control Flexion
Degrees




           80.0                                                               Study Flexion
                                                                              Control ER
          60.0
                                                                              Study ER
           40.0


           20.0


            0.0
                  Initial Visit     1 Month       2 Month       3 Month


                             No Significant Difference Between the 2 Groups
Results – Return to Work

                              124.0
       140.0
                                               99.8
       120.0

       100.0

        80.0
Days




       60.0

       40.0

        20.0

         0.0



                         Control Group    Study Group

               No Significant Difference Between the 2 Groups
Results – Days to Discharge
                                p = 0.02


                    241.7
        250.0


        200.0
                                      139.7
        150.0
 Days




        100.0


         50.0


          0.0



                Control Group   Study Group
Results - Failures
                         p = 0.078




 4

3.5

 3
         4/26
2.5

 2

1.5

 1
                            1/35
0.5

 0

         Control Group      Study Group
Results
• No significant difference in
   – VAS pain scores
   – ASES scores
   – Return to work
   – Failures - 15.4% to 2.9%

• Significant difference in
   – Days to discharge
Discussion
• The PASTABridge is just as effective as trans-tendon repairs but
    – Easy, percutaneous technique
    – Does not require any arthroscopic knot tying
    – Minimal risk of damaging shoulder during surgery
    – Proven biomechanical strength


• Will require a randomized controlled trial and larger sample size to
   better evaluate the results
Extension Bridge
Conclusion

• The PASTA Bridge is a viable, simple
  technique to repair PASTA lesions that carries
  minimal risk, compared with current trans-
  tendon techniques
THANK YOU

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PASTA Bridge - A New Technique in PASTA Repairs: A Biomechanical & Clinical Evaluation

  • 1. PASTA Bridge - A New Technique in PASTA Repairs: A Biomechanical & Clinical Evaluation Alan M. Hirahara, M.D., FRCS(C) Private Practice Sacramento, CA USA Medical Director Team Physician Consultant Sacramento State Athletics Sacramento River Cats Oakland A’s MiLB - AAA
  • 3. Objective of Study • To evaluate the biomechanical strength & clinical effectiveness of a new PASTA repair technique – PASTA Bridge • To introduce a novel technique in PASTA repair that is significantly easier, carries less risk, does not require arthroscopic knot tying, and is as effective as current trans- tendon techniques
  • 4. Introduction • In the literature, PASTA lesions can cause significant pain for patients • Debridement alone of tears < 50% thickness can result in good/excellent outcomes but can progress on to full thickness tears (6.5-34.6%) • Current repair techniques can lead to excellent results but are technically challenging Romeo et al. Arthroscopy 2011; 27(4): 568-80.
  • 5. Study Design - Biomechanical • Case-control study • Six matched pairs of fresh frozed cadaver shoulders – 3 male / 3 female – Average age = 49 ± 12 years
  • 6. Study Design • For each sample, a partial tear of supraspinatus tendon was replicated by using a sharp blade to transect 50% of the medial side of supraspinatus from tuberosity 1 cm wide • From each matched pair, one humerus selected to receive a PASTA repair using one 4.5mm titanium Corkscrew FT • Contralateral repair done using a PASTA Bridge repair • Half of the samples of each repair were performed on the right humeri to avoid a mechanical bias • All repairs performed by an orthopaedic surgeon
  • 7. Study Design • Biomechanical testing conducted using an INSTON 8871 Axial Table Top Servohydraulic Testing System, with a 5kN load cell attached to cross- head • System calibrated using FastTrack software, and load & position controls run through WaveMaker software • Each sample positioned on a fixed angle fixture & secured to testing surface so direction of pull performed 45° to humeral shaft • Custom fixture with inter-digitated brass clamps attached to cross-head, and dry ice was used to freeze the tendon to the clamp
  • 8. Study Design • For each sample, we determined – Ultimate load, yield load, and stiffness – Cyclic displacement and strain of each sample at both the articular margin and at the repair site – Paired t-tests (α = 0.05) to determine if differences in ultimate load or strain between the two repairs were significant
  • 10. PASTA Bridge: Construct Strength Comparison Study SutureTak and SwiveLock PASTA Repair Ultimate Yield Stiffness Displacement (mm) Strain (mm/mm) Donor # Side Gender Age Mode of Failure Load (N) Load (N) (N/mm) Repair Margin Repair Margin 10-09064 R M 62 1637 1637 144 0.12 0.12 1.015 1.009 humeral head broke 10-08024 L M 27 1499 1308 136 0.52 0.21 1.056 1.014 tendon tore mid-substance 10-11021 R F 53 811 811 65 0.29 0.63 1.041 1.043 tendon tore at repair 10-09062 R F 52 899 899 61 0.63 0.44 1.177 1.048 humeral head broke 11-01032 L M 46 402 402 74 0.78 0.36 1.133 1.027 muscle body tore from tendon 10-10068 L F 53 810 660 81 0.48 0.21 1.062 1.016 muscle body tore from tendon Average 49 1010 953 94 0.47 0.33 1.081 1.026 Standard Deviation 12 468 449 37 0.24 0.19 0.061 0.016 Titanium Corkscrew PASTA Repair Ultimate Yield Stiffness Displacement (mm) Strain (mm/mm) Donor # Side Gender Age Mode of Failure Load (N) Load (N) (N/mm) Repair Margin Repair Margin 10-09064 L M 62 1398 1395 112 0.24 0.22 1.026 1.013 muscle body tore from tendon 10-08024 R M 27 1642 1642 122 0.14 0.36 1.024 1.022 tendon tore at repair 10-11021 L F 53 922 922 58 0.37 0.53 1.091 1.033 humeral head broke 10-09062 L F 52 969 969 132 0.34 0.54 1.052 1.041 tendon tore at repair 11-01032 R M 46 1003 1003 88 0.58 0.27 1.094 1.021 muscle body tore from tendon 10-10068 R F 53 575 575 82 0.27 0.49 1.050 1.034 tendon tore at repair Average 49 1085 1084 99 0.32 0.40 1.056 1.027 Standard Deviation 12 378 378 28 0.15 0.14 0.030 0.010
  • 11. PASTA Bridge – Methods of Failure
  • 12. Results • No significant difference in the two groups in all parameters • Mode of failure was always biological, not mechanical
  • 13. Discussion • Despite using smaller anchors, we have created a sturdy, reliable, easy, percutaneous repair technique that is just as strong as conventional larger suture anchor repairs • Minimal risk of damaging shoulder during surgery • Proven biomechanical strength
  • 15. Study Design - Clinical • Case-control study • Collection period: 8/09 – 12/11 • Pain scores, ASES scores taken every month for 6 months – ROM measured pre-op and monthly for 3 months post – Date of discharge and date of return to work were noted
  • 16. Study Design • All patients requiring a PASTA repair • Inclusions: – PASTA lesion > 25% thickness • Exclusions: – any post-operative trauma – non-compliance with physical therapy protocol • Failure to heal: – Evaluated any symptoms 4-6 months post-op with repeat MRA or surgery
  • 17. Patient Data Study Group Control Group • 35 patients • 26 patients • 15 male / 20 female • 12 male / 14 female • Age range: 22 – 80 years • Age range: 17 – 72 years • Age average: 52.07 years • Age average: 47.75 years
  • 18. Results Pain Scores ASES Scores p = NS p = NS 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 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 = 35
  • 19. Range of Motion 160.0 140.0 120.0 100.0 Control Flexion Degrees 80.0 Study Flexion Control ER 60.0 Study ER 40.0 20.0 0.0 Initial Visit 1 Month 2 Month 3 Month No Significant Difference Between the 2 Groups
  • 20. Results – Return to Work 124.0 140.0 99.8 120.0 100.0 80.0 Days 60.0 40.0 20.0 0.0 Control Group Study Group No Significant Difference Between the 2 Groups
  • 21. Results – Days to Discharge p = 0.02 241.7 250.0 200.0 139.7 150.0 Days 100.0 50.0 0.0 Control Group Study Group
  • 22. Results - Failures p = 0.078 4 3.5 3 4/26 2.5 2 1.5 1 1/35 0.5 0 Control Group Study Group
  • 23. Results • No significant difference in – VAS pain scores – ASES scores – Return to work – Failures - 15.4% to 2.9% • Significant difference in – Days to discharge
  • 24. Discussion • The PASTABridge is just as effective as trans-tendon repairs but – Easy, percutaneous technique – Does not require any arthroscopic knot tying – Minimal risk of damaging shoulder during surgery – Proven biomechanical strength • Will require a randomized controlled trial and larger sample size to better evaluate the results
  • 26. Conclusion • The PASTA Bridge is a viable, simple technique to repair PASTA lesions that carries minimal risk, compared with current trans- tendon techniques