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
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
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)
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.