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 PRPAnchors 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
Well designed animal studyImproved strength, stiffness, ultimate load of repair. Increased cross sectional area Biocompatable (canine model) No clinical resultsNo 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 toleratedRotator cuff repair augmentation using a novel polycarbonate polyurethane patch: preliminary results at 12 months’ follow-up Ivan Encalada-Diaz et al JSES 2011
(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 ReactionPorcine 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 thisbiochemical matrix and resultsin an extracellular framework that is completely intact. This intact matrix, complete with preserved vascularchannels, 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 TearsWayne 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 MRIArthroscopic 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 techniqueHealing 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 62An 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 monthsEarly 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.