Rotator cuff repair: challenges and solutions

Figures & data

Figure 1 Modes of rotator cuff failure.

Notes: (A) Intact repair on MRI. Note the position of the musculotendinous (MT) junction at the midpoint of the humeral head. (B) Failure with defect on MRI. Note the defect at the greater tuberosity and the significantly retracted position of the MT junction. (C) Failure with continuity on MRI. Note the continuous tissue extending to the greater tuberosity despite significant retraction of the MT junction. White arrows in A–C show position of the MT junction. (D) Illustration of failure with defect. (E) Illustration of failure with continuity. Illustrations by David Schumick, BS, CMI. Reprinted with the permission of the Cleveland Clinic Center for Medical Art and Photography © 2015. All Rights Reserved.
Abbreviation: MRI, magnetic resonance imaging.

Table 1 Studies of commercially available scaffolds in augmentation of rotator cuff repairs

Device	Reference (year)	Study design (level of evidence)	Tear size	Sample size	Method of application	Follow-up	Structural failure^*	Functional outcomes^†	Conclusion
Graftjacket^® (human dermis)	Burkhead et al (2007)^Citation53	IV (retrospective case series)	Massive	17	Open	14 months	3/12	UCLA: 9.06→26.12	No adverse events reported. Scores, strength, ROM improved; 14/17 patients satisfied with outcome. Recurrent tears were smaller than on pre-operative MRI.
	Barber et al (2012)^Citation57	II (prospective randomized controlled trial)	Two-tendon (>3cm)	NA: 20 A: 22	Arthroscopic	12-38 months	N A: 9/15 A: 3/20	UCLA: NA 28.3, A 28.2 Constant: NA 85.3, A 91.9 ASES: NA 85.3, A 98.9	No adverse events reported. Augmented group had significantly better Constant and ASES scores, and significantly better healing rate by MR arthrogram, compared to nonaugmented group.
X-Repair^® (poly-L-lactide)	Proctor (2014)^Citation61	IV (retrospective case series)	Large or massive	18	Arthroscopic	35-47 months	4/18	ASES: 26→70	No adverse events reported. Mean ASES score for intact repairs =82.
	Lenart et al (2014)^Citation88	IV (retrospective case series)	Massive	13	Open	14-20 months	8/13	Penn: 50.9→70.6 ASES: 32.8→74.2	No adverse events reported. Significant improvement in functional outcomes despite high rate of structural failure.
Allopatch HD^™ (human dermis)	Agrawal (2012)^Citation89	IV (retrospective case series)	Large, massive, or recurrent	14	Arthroscopic	14-19 months	2/14	Flex SF: 53.7→79.7 Constant: 49.7→81.1	No adverse events reported. Scores, pain, strength, ROM improved. Recurrent tears were smaller than on preoperative size.
Acellular Human Dermal Matrix (human dermis)	Rotini et al (201 I)^Citation90	IV (retrospective case series)	Large or massive	5	Arthroscopic (2/5) or open (3/5)	12-18 months	2/5	Constant: 64→88	No adverse events reported. Healed repairs showed graft incorporation into native tissue on MRI.
Zimmer^® Collagen Repair (porcine dermis)	Cho et al (2014)^Citation91	IV (retrospective case series)	Massive	5	Mini-open	14-27 months	1/5	UCLA: 15.4→31.2 ASES: 39.4→86.4	No adverse events reported. Scores and pain improved. There was 1 partial retear.
Tutopatch^® (TP) (bovine-derived pericardium), Repol Angimesh® (RA) (polypropylene)	Ciampi et al (2014)^Citation58	III (retrospective comparative study)	Massive	NA: 51 TP: 49 RA: 52	Open	36 months	NA: 21/51 TP: 25/49 RA: 9/52	UCLA: NA 14.88, TP 14.69, RA 24.61	No adverse events reported. RA group had significantly better UCLA scores, strength, and ROM at 36 months. Retear rate significantly lower in RA group.
Biomerix RCR Patch™ (polycarbonate polyurethane)	Encalada-Diaz et al (2011)^Citation59	IV (retrospective case series)	Small, medium (mean 2 cm)	10	Open	12 months	1/10	ASES: 44→73 UCLA: 29.2 SST: 3.6→7.7	Smaller tears (single tendon tears of supraspinatus or infraspinatus). No adverse events reported. Scores, pain, ROM improved.
SportMesh^™ (polyurethaneurea)	Petriccioli et al (2013)^Citation60	IV (retrospective case series)	Two-thirds to complete subscapularis tears	10	Open	12-34 months	1/10	Constant: 47→69	No adverse events reported. Scores, pain, strength improved. 6 excellent, 2 good, 2 fair results by DASH.

Notes: Most clinical studies are retrospective case series without control groups that demonstrate improved patient outcomes over the preoperative state and relatively low rates of structural failure. Adverse events with these currently available scaffolds are rare.

* Not all patients underwent imaging for evaluation of structural failure.

† The arrows in the functional outcomes column denote change from pre- to postoperative values.

Abbreviations: A, augmented; ASES, American Shoulder and Elbow Surgeons Shoulder Score; DASH, Disabilities of the Arm, Shoulder, and Hand Outcome Measure; Flex SF, Flexilevel Scale of Shoulder Function; MRI, magnetic resonance image; NA, nonaugmented; Penn, Penn Shoulder Score; ROM, range of motion; SST, Simple Shoulder Test; UCLA, University of California, Los Angeles Shoulder Score.

Table 2 Studies of commercially available scaffolds in interposition of irreparable rotator cuff tears

Device	Reference (year)	Study design (level of evidence)	Tear size	Sample size	Method of application	Follow-up	Structural failure^*	Functional outcomes^†	Conclusion
Graftjacket^® (human dermis)	Dopirak et al (2007) ^Citation54 Bond et al (2008)^Citation55	IV (retrospective case series)	Massive, irreparable	16	Arthroscopic	12-38 months	3/16	UCLA: 18.4→30.4 Constant: 53.8→84	No adverse events reported. Scores, pain, strength, ROM improved; 15/16 patients satisfied with outcome. Thirteen patients had full incorporation of graft into native tissue on MRI.
	Wong et al (2010)^Citation56 (update from Bond et al 2008)	IV (retrospective case series)	Massive, irreparable	45	Arthroscopic	24-68 months	n/a	UCLA: 18.4→27.5 WORC: 75.2 ASES: 84.1	Deep wound infection developed in one (immunocompromised) patient, requiring arthroscopic irrigation and debridement and antibiotics. One long-term neuropraxia occurred and resolved at 1 year. Surgical time noted to be consistently less than 3 hours.
	Gupta et al (2012)^Citation92	IV (retrospective case series)	Massive, irreparable	24	Mini-open	29–42 months	5/19	SF-12: 48.8→56.8 ASES: 66.6→88.7	No adverse events reported. Scores, pain, strength, ROM improved; and all patients satisfied with outcome. There were no complete retears, only partial retears.
Fascia lata autograft	Mihata et al (2013)^Citation93	IV (retrospective case series)	Large, or massive, irreparable	24	Arthroscopic, superior capsule reconstruction	24-51 months	4/24	ASES: 23.5→92.9	No adverse events. Graft used to recreate superior capsule from superior glenoid to greater tuberosity. Improved motion and functional outcomes, with high rate of structural integrity.
	Mori et al (2013)^Citation94	III (retrospective comparative study)	Large, or massive, irreparable	FL: 24 PR: 24	Arthroscopic	35 months	FL: 2/24 PR: 10/24	ASES: FL: 40.8→90.1 PR: 41.8→85.7 Constant: FL: 37.4→81.1 PR: 36.3→69.9 UCLA: FL: 14.3→32.6 PR: 13.7→29.8	No adverse events. Fascia lata autograft resulted in improved structural and functional outcomes compared to partial repair of irreparable large or massive rotator cuff tears.
Zimmer^® Collagen Repair (porcine dermis)	Soler et al (2007)^Citation51	IV (retrospective case series)	Massive	4	Open	3-6 months	4/4	n/a	Older patient population (71-82 years). Graft disruption occurred between 3 and 6 months postoperatively in all patients. Inflammatory reaction seen in all patients, with graft disintegration and tissue necrosis observed at revision surgery.
	Badhe et al (2008)^Citation52	IV (retrospective case series)	Large or massive	10	Open	3-5 years	2/10	Constant: 42→62	No adverse events reported. Scores, pain, ROM, abduction power improved; 9/10 patients satisfied with outcome.
Conexa^™ (porcine dermis)	Gupta et al (2013)^Citation95	IV (retrospective case series)	Massive, irreparable	27	Mini-open	24–40 months	6/22	SF-12: 48.4→56.6 ASES: 62.7→91.8	No adverse events reported. Scores, pain, strength, ROM improved. All but one patient satisfied with outcome. There was one complete retear and five partial retears.
LARS graft (polyester terephthalate)	Petrie and Ismaiel (2013)^Citation62	IV (retrospective case series)	Massive, irreparable	31	Open	24-72 months	n/a	Oxford: 46.7→30.6	No adverse events reported. Graft not always secured medially to retracted tear stump. Lower Oxford score is better. Scores and pain improved. Two revisions with graft failure noted, but other cases not imaged postoperatively for healing.

Notes: Most clinical studies are retrospective case series without control groups that demonstrate improved patient outcomes over the preoperative state and relatively low rates of structural failure. Adverse events with these currently available scaffolds are rare.

* Not all patients underwent imaging for evaluation of structural failure.

† The arrows in the functional outcomes column denote change from pre- to postoperative values.

Abbreviations: ASES, American Shoulder and Elbow Surgeons Shoulder Score; FL, fascia lata; LARS, ligament advanced reinforcement system; MRI, magnetic resonance image; n/a, not applicable; Oxford, Oxford Shoulder Score; PR, partial repair; ROM, range of motion; SF-12, 12-Item Short Form Health Survey; UCLA, University of California, Los Angeles Shoulder Score; WORC, Western Ontario Rotator Cuff Index.

Table 3 Level I and II studies on PRP use in rotator cuff repair

PRP product	Device	Reference (year)	Study design (level of evidence)	Tear size	Sample size (PRPicontrol)	Follow-up	Structural failure^*	Functional outcomes^†	Conclusion
Platelet-Rich Fibrin Matrix (PRFM)	Cascade Autologous Platelet System (Musculoskeletal Transplant Foundation, Edison, NJ)	Castricini et al (2011)^Citation76	1 (randomized controlled trial)	Small or medium	43:45	16 months	PRFM: 1/43 C: 4/45	Constant: PRFM: 42.0→88.4 C: 42.9→88.4	No adverse events. Improved tendon signal in PRFM group. No differences in strength, constant scores, or structural failure.
		Rodeo et al (2012)^Citation80	II (randomized controlled trial)	Small, medium, or large	40:39	12 months	PRFM: 12/36 C: 6/3 1	ASES: PRFM: 56.2→91.3 C: 54.7→96.4 L’lnsalata: PRFM: 50.6→90.4 C: 50.6→94.1	No adverse events. No differences in functional scores, structural integrity, or strength at final follow- up, but PRFM group was 5.8 times more likely to have recurrent defect.
		Weber et al (2013)^Citation82	1 (randomized controlled trial)	Any (mean 1.7 cm)	29:30	12 months	PRFM: 12/28 C: 7/24	ASES: PRFM: 82.5 C: 82.5 UCLA: PRFM: 27.9 C: 29.6	No adverse events. No differences in early pain scores, or final functional scores or structural integrity.
Platelet Leukocyte Membrane (PLM)	RegenKit (Regen Lab, Le Mont-Sur-Lausanne, Switzerland)	Gumina et al (2012)^Citation77	1 (randomized controlled trial)	Large	39:37	13 months	PLM: 0/39 C: 3/37	Constant: PLM: 54.3→77.9 C: 50.1 →74.2 SST: PLM: 3.7→10.5 C: 3.4→10.1	No adverse events. Improved structural integrity in PLM group, but no differences in Constant or SST scores.
Platelet Rich Plasma Gel (PRPG)	COBE Spectra LRS Turbo (Cardidian BCT, Lakewood, CO)	Jo et al (2011)^Citation78	II (prospective cohort study)	Any (mean 2.6-3.5 cm)	20:18	12 months	PRPG: 4/15 C: 7/17	Equivalent Constant, ASES, UCLA, DASH, SST, SPADI scores	No adverse events. Improved ASES, Constant, and SPADI scores at 3 months, but no differences in structural or functional outcomes at final follow-up.
Platelet Rich Plasma (PRP)	GPS II - Plasmax - Platelet Concentration System (Biomet Biologies, Warsaw, IN)	Randelli et al (2011)^Citation79	1 (randomized controlled trial)	Any	22:23	24 months	PRP: 9/22 C: 12/23	Constant: PRP: 44→82.4 C: 42.2→78.7 UCLA: PRP: 15.3→33.3 C: 14.5→31.0 SST: PRP: 4.8→11.3 C: 4.7→10.9	No adverse events. Improved pain, functional scores, and strength at 3 months, but no differences in pain, functional scores, strength, or structural integrity at final follow-up.
Plasma Rich in Growth Factors (PRGF)	PRGF System/(B.T.I. Biotechnology Institute, Vitoria- Gasteiz, Spain)	Ruiz-Moneo (2013)^Citation81	1 (randomized controlled trial)	Medium, large, or massive	32:31	12 months	PRGF: 13/32 C: 1 1/28	UCLA: PRGF: 14.9→23.2 C: 14.8→23.8	No adverse events. No differences in functional scores or structural integrity at final follow-up.
Plasma-Rich Fibrin (PRF)	Vivostat PRF (Vivostat A/S, Alleroed, Denmark)	Antuna (2013)^Citation83	1 (randomized controlled trial)	Massive	14:14	12 months	PRF: 9/14 C: 6/14	Constant: PRF: 39.7→65.6 C: 34.3→64.1	No adverse events. No differences in functional scores or structural integrity at final follow-up.

Notes: Some studies suggest slightly better healing with PRP use, while others suggest no difference or even worse healing. Overall there are no differences in structural integrity or functional outcomes with PRP use. Adverse events have not been reported.

* Not all patients underwent imaging for evaluation of structural failure.

† The arrows in the functional outcomes column denote change from pre- to postoperative values.

Abbreviations: ASES, American Shoulder and Elbow Surgeons Shoulder Score; C, control; DASH, Disabilities of the Arm, Shoulder, and Hand Outcome Measure; L’Insalata, L’Insalata Shoulder Score; SPADI, Shoulder Pain and Disability Index; SST, Simple Shoulder Test; UCLA, University of California, Los Angeles Shoulder Score.

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