Table 1.

Commercially available scaffolds for rotator cuff repair.

Brand name	Composition	Company	Study type/Level of evidence	Sample size	Repair technique	Follow-up period	Clinical outcome	Ref.
Naturally derived
GraftJacket™	Human dermis	Wright Medical, Arlington, TN, USA	Cohort/3	47	Interposition	9.1 years	Improved clinical outcomes (Oxford shoulder score) and high patient satisfaction that was maintained at 9.1 years.	Modi et al., 2022 [189]
AlloPatch®	Human dermis	MTF Sports Medicine, Edison, NJ, USA	Retrospective case series/4	14	Augmentation	1 year	Majority of rotator cuffs (85.7% were intact) with improved clinical outcomes (Constant score, Flexilevel Scale of Shoulder Function, pain score, scapular plane abduction, and strength).	Agrawal, 2012 [190]
ArthroFLEX®	Human dermis	Arthrex, LifeNet Health, Virginia Beach, VA, USA	Controlled laboratory study (Cadaver)/3	25	Interposition or Augmentation	—	Both augmentation and interposition repair increased ultimate load in cadaver shoulders.	Beitzel et al., 2022 [191]
TissueMend®	Fetal bovine dermis	Stryker Orthopedics, Mahwah, NJ, USA	Technical note/6	NA	Augmentation	NA	NA	Seldes et al., 2006 [192]
Bio-Blanket®	Bovine dermis	Kensey Nash Corporation, Exton, PA, USA	Review/7	NA	Augmentation	NA	NA	Coons and Barber, 2006 [193]
Zimmer or Permacol™	Porcine dermis	Medtronics, Mansfield, MA, USA	Case series/4	10	Augmentation	4 weeks	Disruption of extracellular matrix underlying both patches was observed. 1 patient had adverse tissue immune response.	Rashid et al., 2020 [88]
Conexa™	Porcine dermis	Tornier, Edina, MN, USA	Case series/4	4	Interposition	10.5 months	Favourable remodeling of graft with vessel infiltration without evidence of inflammation, foreign body reaction, or tissue rejection.	Christian et al., 2021 [194]
Biotape®	Porcine dermis	Wright Medical, Arlington, TN, USA	Review/7	NA	Augmentation	NA	NA	Karuppaiah et al., 2019 [195]
				24	NA	About 2 weeks	Comparable proliferation and tendon gene expression as other commercial grafts.	Smith et al., 2016 [196]
Restore™	Porcine small intestine submucosa	DePuy Orthopedics, Warsaw, IN, USA	Controlled trial/3	31	Augmentation	2 years	Poor clinical outcomes including lower strength and more impingement in external rotation with slower resolution of pain and more difficulty in daily living activities.	Walton et al., 2007 [197]
CuffPatch®	Porcine small intestine submucosa	Arthrotek, Warsaw, IN, USA	Controlled laboratory study (Rat)/3	126	Interposition	112 days	Presence of foreign-body giant cells, chronic inflammation and accumulation of dense, poorly organize fibrous tissue.	Valentin et al., 2006 [198]
Tutopatch®	Bovine pericardium	Tuto-gen Medical GmbH, Neunkirchen am Brand, Germany	Retrospective case series/4	152	Augmentation	3 years	Similar clinical outcome (UCLA score), retear rate, pain, strength, and elevation as control (open repair) group.	Ciampi et al., 2014 [93]
OrthADAPT®	Equine pericardium	Pegasus Biologic Inc., Irvine, CA, USA	Controlled laboratory study (Rat)/3	41	NA	3 months	Increased maximum load compared to suture only repair at 3 months.	Tornero-Esteban et al., 2015 [199]
Synthetic (Non-degradable)
Leeds-Keio®	Polyester ethylene terephthalate	Xiros plc, Neoligaments, Leeds, UK	Randomized controlled trial/1	39	Augmentation	2 years	Improved clinical outcomes (Hospital for Special Surgery score), decreased pain, increased range of motion, and increased strength.	Tanaka ​et al., 2006 [200]
Poly-tape®	Polyester ethylene terephthalate	Yufu Itonaga Co., Ltd, Tokyo, Japan	Controlled laboratory study (in vitro)/3	24	NA	About 2 weeks	Comparable proliferation and tendon gene expression as other commercial grafts.	Smith et al., 2016 [196]
Mersilene® mesh	Polyester ethylene terephthalate	Ethicon, Inc., Somerville, NJ	Case series/4	41	Interposition	43 months	Improved clinical outcomes (Constant score), reduced pain and improved daily living activities.	Audenaert et al., 2006 [201]
Lars® ligament	Terephthalic polyethylene polyester	Ligament Augmentation and Reconstruction System, Dijon, France	Controlled laboratory study (in vitro)/3	24	NA	About 2 weeks	Comparable proliferation and tendon gene expression as other commercial grafts.	Smith et al., 2016 [196]
Gore-Tex® patch	Polytetrafluoroethylene	Gore and Associates, Flagstaff, AZ, USA	Case series/4	28	NA	44 months	Improved clinical outcome (JOA score), reduced pain, and increased abduction strength.	Hirooka et al., 2002 [202]
Marlex®	High-density polyethylene	C.R.Bard, Mullayhill, NJ, USA	Case series/4	9	Capsular reconstruction	3–48 months	Improved clinical outcome with respect to joint instability although there were two surgical complications.	Gortzak et al., 2010 [203]
Repol Angimesh®	Polypropylene	ANGIOLOGICA BM Srl, Pavia, Italy	Retrospective case series/4	152	Augmentation	3 years	Improved clinical outcome (UCLA score) as well as, lower retear rate, lower pain, increased strength, and increased elevation as control (open repair) group.	Ciampi et al., 2014 [93]
Synthetic (Degradable)
X-Repair	Poly-L-lactic-acid	Synthasome Inc., San Diego, CA, USA	Case series/4	18	Augmentation	42 months	Improved clinical outcomes (ASES score) with 78% intact repair at 42 months.	Proctor, 2014 [204]
Artelon® or SportMesh™	Polyurethane urea polymer	Artimplant AB, Sweden	Case study/6	3	Augmentation	6 months-2.5 years	Improved clinical outcomes (WORC and Oxford score) with integrity of rotator cuff retained at 15-months postoperatively for one patient. Remaining two patients showed improved Constant score (17% and 79%) at six months.	Zhaeentan et al., 2011 [205]
Integraft™	Carbon fibre	Hexcel Medical, Dublin, CA	Review/7	NA	Augmentation	NA	NA	Karuppaiah et al., 2019 [195]
BioFiber™	Poly(4-hydroxybutyrate)	Tornier, Edina, MN, USA	Controlled laboratory study (in vitro)/3	24	NA	About 2 weeks	Comparable proliferation and tendon gene expression as other commercial grafts.	Smith et al., 2016 [196]

∗NA, not available