Graft type (product name)
Material type
Surgical use reported
Reported strengths
Reported weaknesses
Literature cited with level of evidence
Current status
Mersilene mesh
Synthetic
Primary open massive cuff repair [31]
Improved clinical scores, pain relief, and performance of activities of daily living (ADLs) [31]
No level I–II evidence—comparisons only made pre- and postoperatively
Audenaert et al. [31]—level IV
Clinical use, case series
Porcine dermal xenograft (Permacol)
Biologic xenograft
Massive open cuff repair [32]
Improved clinical scores, pain, strength, and ROM postoperatively [32]
No level I–II evidence—comparisons only made pre- and postoperatively
Badhee et al. [32]—level IV
Clinical use, case series
Porcine small intestine xenograft (restore)b
Biologic xenograft
Massive open cuff repair [33]
RCT demonstrates no clinical improvements, not recommended [33]
Worse clinical measures postoperatively in multiple patients [26]
Poor overall outcomes reported in additional studies [25]
Animal studies demonstrate porcine DNA and cell presence associated with in vivo inflammatory response [34]
Iannotti et al. [33]—level II
Sclamberg et al. [26]—level IV
Clinical use, RCT
Platelet-rich plasma (PRP) loaded fibrin matrix (PRPFM) (cascade autologous platelet system)c
Biologic
Severe arthroscopic cuff repair [35]
Full-thickness arthroscopic cuff repair [36]
Small to medium arthroscopic repairs [37]
Lower re-tear rates reported with mixed results from clinical scores [36]
Level III—cohort study found no difference between groups [35]
Not useful for small to medium size tears [37]
Bergeson et al. [35]—level III
Barber et al. [36]—level III
Castricini et al.—level I [37]
Clinical use, RCT
Platelet-rich plasma (PRP)d gel applied to suture (PDS) or other non-matrix material
Biologic/synthetic
Arthroscopic rotator cuff repair [38]
No advantages documented
No differences observed, study allowed patients to choose treatment, possibly suboptimal application technique [38]
Jo et al.—level II–III
Clinical use, cohort study
Acellular human dermal matrix (GraftJacket)e
(GraftJacket Maxforce and Maxforce Extreme options)
Biologic
Primary, 2-tendon, >3 cm arthroscopic cuff repairs [27]
Massive arthroscopic cuff repairs [39]
Massive mini-open cuff repair [40]
Massive arthroscopic cuff repair [41]
Multicenter RCT with positive results found decreased re-tear rates and improved clinical scores [27] compared to controls
Safety established for human dermal matrix [42] with a different production method than GraftJacket
Biomechanically favorable suture grasp when compared to other products for GraftJacket Maxforce Extreme [43]
Very small number of participants in RCT [27]
Barber et al. [27]—level II
Bond et al. [39]—level IV
Gupta et al. [40]—level IV
Wong et al. [41]—level IV
Rotini et al. [42]
Clinical use, RCT
Free total or partial coracoacromial ligament graft
Biologic
Massive mini-open cuff repair [44]
Improved ROM and improved clinical scores postoperatively [44]
No level I–II evidence—comparisons only made pre- and postoperatively
Bektaser et al. [44]—level IV
Clinical use, case series
Autologous bone marrow mononuclear cells
Biologic
Consecutive rotator cuff injuries at a single institution—mini-open cuff repair [45]
Improved functional scores and no re-tears in a 14 patient series [45]
No level I–II evidence—comparisons only made pre- and postoperatively
Lack of clearly defined patient population and small study size
Iliac crest donor site morbidity [45]
Ellera Gomes et al. [45]—level IV
Clinical use, case series
Reticulated polycarbonate polyurethane patchf
Synthetic
Consecutive supraspinatus tears—open cuff repair [46]
Decreased pain, improved clinical scores, and low re-tear rate [46]
No level I–II evidence—comparisons only made pre- and postoperatively
Small case series
Encalada Diaz et al. [46]—level IV
Clinical use, case series
Gore-Tex soft tissue patchg
Synthetic
Consecutive medium to large cuff tears—mini open [47]
Decreased pain, improved clinical scores, and better abduction strength with small Gore-Tex patch [47]
Lower abduction strength with larger patches [47]
Hiooka et al. [47]—level IV
Clinical use, case series
Fascia lata allografts (freeze dried)h
Biologic
Massive open rotator cuff repair [48]
Similar clinical results to McLaughlin procedure, with lower re-tear rates [48]
Case series compared to heterogeneous patient population [48]
Ito and Morioko—level IV [48]
Clinical use, case series
Tendon allograft (heterogeneous tendon sources) [24]
(rotator cuff tendon) [22]
Biologic
Massive open rotator cuff repair [24]
Reliable alleviation of pain
No single tendon used as allograft: patellar, Achilles, and quadriceps tendons [24]
No apparent improvement in outcomes [23]
Study conducted in 1978 limited subjects in a case series [22]
Moore et al.—level IV [24]
Nasca et al. [23]—level IV
Neviaser et al. [22]—level IV
Clinical use, case series
Polyester fiber mesh ligament (Dacron)i
Synthetic
Massive arthroscopic cuff repair and Dacron ligament construction [49]
Improved clinical score and improved range of motion [49]
No level I–II evidence—comparisons only made pre- and postoperatively
Nada et al. [49]—level IV
Clinical use, case series
Deltoid muscle transfer/flap
Biologic
Supraspinatus confirmed—open repair
Improved ROM, clinical scores, and strength. Long-term follow-up [50]
No level I–II evidence—comparisons only made pre- and postoperativelya
Not recommended for massive tears or those including subscapularis [50]
Gedouin et al. [50]—level IV
Clinical use, case series
Carbon fiber (Intagraft)
Synthetic
Massive open cuff repairs [51]
Predominantly good to excellent reported outcomes in available series [51]
No level I–II evidence—comparisons only made pre- and postoperatively
Risk of humeral cyst associated with graft placement
Visuri et al. [51]—level IV
Clinical use, case series
Periosteal flap
Biologic
Degenerated tears—open cuff repair [52]
Improved clinical scores and moderately low re-tear rate (20 %) [52]
No level I–II evidence—comparisons only made pre- and postoperatively
Risk of rotator cuff calcification, not correlated with inferior clinical outcomes [52]
Sceibel et al. [52]—level IV
Clinical use, case series
Tenotomized biceps tendon
Biologic
Massive arthroscopic repair [53]
Reported improvement in some aspects of ROM, strength, and image- based healing [53]
No level I–II evidence—comparisons only made pre- and postoperatively
Cho et al. —level IV [53]
Clinical use, case series
SportMeshj—knitted polyurethane urea fabric33
Synthetic
Biomechanical studies
Most displacement in biomechanical studies of augmentation products [43]
Lower load at failure than commercially available comparators described by Barber et al. [43]
Barber et al.—Preclinical study [43]
Clinical use, no formal investigation
Allopatch HDk 2, acellular human collagen matrix from fascia lata [43]
Biologic
Biomechanical studies
Higher reported load to failure in biomechanical tests and compared to several commercially available alternatives [43]
No clinical data
Barber et al.—Preclinical study [43]
Clinical use, no formal investigation
OrthAdaptl, cross-linked equine pericardium [43]
Biologic xenograft
Biomechanical studies
Lower load at failure than commercially available comparators described by Barber et al. [43]
Barber et al.—Preclinical study [43]
Clinical use, no formal clinical investigation
RC Allograftm—freeze-dried rotator cuff cleansed allograft [43] is provided to Arthrex by Allograft Tissue Systems
Biologic
Biomechanical studies
Lower reported elongation during cyclical biomechanical testing [43]
No clinical data
Barber et al.—Preclinical study [43]
Clinical use, no formal clinical investigation
CuffPatchn—porcine small intestine
Biologic xenograft
Biomechanical studies
Studies of restore, with a similar tissue origin raise concerns for inflammatory reactions associated with this product [34]
Zheng et al.—Preclinical study [34]
Clinical use, no formal clinical investigation
TissueMendo—highly processed fetal bovine skin graft, non-artificially cross-linked 99 % non-denatured bovine collagen [54]
Biologic xenograft
Biomechanical studies
High levels of remnant DNA in tested specimens [55]
No clinical data
Barber et al.—Preclinical study [43]
Clinical use, no formal clinical investigation
Leeds-Keio artificial ligamentp
Synthetic
RCT of shoulder arthroplasty in patients with rheumatoid arthritis with and without rotator cuff reconstruction and augmentation
Good biomechanical profile
RCT demonstrating superior pain and function scores in augmented reconstructions paired with shoulder arthroplasty [56]
Findings mainly limited by the study population
Clinical studies for rotator cuff augmentation limited to arthroplasty cases requiring reconstruction, historically largely used for reconstruction of the anterior cruciate ligament of the knee, met with mixed but fairly positive results
Tanaka et al.—level II [56]
Clinical use, RCT
X-repairq, poly-l-lactic acid (PLLA) mesh
Synthetic
Biomechanical studies [57]
Superior biomechanical performance of repairs in cadaveric studies [57]
Complications associated with PLLA implants may be of concern in proximity to the shoulder joint [58]
McCarron et al.—level IV [57]
Preclinical, few public studies
The ideal graft is replaced slowly enough to provide structural support to the repair as the native rotator cuff tendon heals, typically occurring over months. A graft that is too resistant to degradation, however, may lead to encapsulation and scar formation [28, 61]. A graft that rapidly degrades may promote an immunologic response which can lead to soft tissue swelling and inflammation mimicking an infection.
There are currently no randomized controlled trials comparing graft materials used for augmentation of rotator cuff repair in humans. Thinner grafts tend to have lower suture pullout strength [43]. Grafts that are cross-linked tend to have less elongation to failure, but cross-linking does not necessarily correlate to mechanical strength [62]. More pliable grafts are useful for arthroscopic graft augmentation so that the graft may be folded, pushed, and pulled through the cannula while resisting tearing.
Dermal allografts , such as the GraftJacket® graft (Wright Medical Technology, Arlington, TN), currently have the highest quality data supporting their safety and effectiveness [27, 39–42, 59]. Burkhead et al. reported early success in 2007 with dermal allograft used for open augmentation of massive rotator cuff tears, with pain scores improving in 64 % and near normal function in 70 % at 1.2-year follow-up in 17 patients [63]. A 2012 randomized, prospective study with 2-year follow-up also showed success with dermal allograft used for arthroscopic augmentation of large or massive rotator cuff tears. This study showed rotator cuffs to be more frequently intact, based on postoperative MRI when augmented with dermal allograft as compared to those that were not, 85 % versus 40 %, respectively, with associated improved function in those that were augmented [27].
Porcine xenografts have also been studied for rotator cuff augmentation. Porcine small intestine submucosa xenograft has been proposed as a graft material for rotator cuff augmentation; however, multiple studies have shown poor results with this material [25, 26, 33, 34]. A 2007 clinical study did not demonstrate a benefit for the use of porcine small intestine submucosa xenograft in rotator cuff augmentation. The xenograft group actually had decreased functional results and equal re-tear rates at 2-year follow-up compared with conventional rotator cuff repair. Also, 21 % of patients in the xenograft group developed a pseudoseptic inflammatory reaction requiring repeat surgery for irrigation and debridement [25]. Similar negative results were seen in a 2004 study with a 90 % re-tear rate seen on postoperative MRI [26]. However, porcine dermal xenograft may prove efficacious as a 2007 clinical study demonstrated improved functional results and 80 % intact grafts on postoperative imaging, with no adverse events reported [32].
Synthetic grafts have also been used and studied for augmentation of rotator cuff tears. Successful results were reported with the use of Gore-Tex (polytetrafluoroethylene) materials with improved functional results following rotator cuff augmentation. There was however greater abduction strength in the small patch group (≤2 cm) compared with the large patch group (>2 cm) and a 10 % re-tear rate between the rotator cuff and the graft, which required reoperation [47]. The Leeds-Keio artificial ligament is another synthetic graft, which is composed of polyester and has a mesh structure. This graft was studied in a 2006 prospective, randomized controlled study supporting its use in augmented subscapularis transposition for rheumatoid arthritis patients undergoing total shoulder arthroplasty [56].
Clinical Evaluation
Before considering graft augmentation, it is imperative to perform a detailed history and physical examination of the affected shoulder. Is the tear acute, chronic, or acute-on-chronic? An acute tear , even if it is large, is typically easier to reduce and has greater healing capacity than a chronic tear. Chronic tears typically have poor tissue quality due to degeneration and fatty infiltration. Large, chronic tears may develop atrophy that is visible on gross inspection of the supraspinatus and/or infraspinatus fossa. Acute-on-chronic tears may be caused by a new large tear in the setting of poor tissue quality from the chronic smaller tear, making the tear easier to reduce but still more difficult to heal because of the degenerative tissue.
Physical Examination
Evaluate both passive and active range of motion. Decreased active range of motion can be caused by pain, weakness, or secondary capsular contraction from lack of use. Capsular contraction causing limited passive motion needs to be addressed for a successful repair, either by preoperative physical therapy or intraoperative capsular release. The function of each specific cuff muscle should be tested individually.
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