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. 2021 Mar 13;17:218–222. doi: 10.1016/j.jcot.2021.02.022

Interposition grafting for irreparable rotator cuff tears: Systematic review and specialist practice report

Aziz Haque 1, Amit Modi 1,∗
PMCID: PMC8047223  PMID: 33868918

Abstract

The treatment of symptomatic irreparable rotator cuff tears poses significant challenges to both patients and shoulder surgeons. Although reverse shoulder arthroplasty provides reliably good outcomes in the elderly, it is not a good option in younger patients. Various surgical techniques have been proposed for the treatment of irreparable rotator cuff tears; however, no gold standard currently exists. Interposition grafting is used when the rotator cuff cannot be fully repaired onto its footprint, and the remaining defect is bridged with either an allograft, autograft, xenograft or a synthetic graft. This review aims to present the literature on the use of various interposition grafts and techniques to treat large or massive irreparable rotator cuff tears and provide a specialist practice report.

Keywords: Rotator cuff tear, Massive irreparable, Interposition graft, Bridging graft, Acellular: dermal matrix graft, Rotator cuff repair and reconstruction

1. Background

Rotator cuff tears (RCT) are common and can lead to significant pain, weakness and disability. Its prevalence ranges between 4% in asymptomatic patients below 40 years to 54% in patients over 60. If conservative treatment fails, then a repair should be considered. Large or massive cuff tears with a defect of over 5 cm and involvement of at least two tendons are more likely to be irreparable. Re-tear rates of 20%–90% have been reported following repair of large to massive tears.1 Despite advances in surgical techniques, instruments, anchors and suture materials, these tears pose a significant challenge for both patients and shoulder surgeons. Untreated large or massive RCTs can propagate and decompensate the shoulder leading to progressive loss of function and rotator cuff arthropathy, as the ability to maintain the joint centre of rotation and avoid superior migration of the humeral head is lost.2

Treatment options for massive irreparable tears include corticosteroid injections with physiotherapy, arthroscopic debridement,3 partial repair,4 tendon transfers,5,6 interposition grafts (human, bovine, porcine, synthetic), superior capsule reconstruction, balloon interposition, and reverse shoulder arthroplasty. Physiotherapy particularly focusing on recruiting the anterior deltoid has been shown to be an effective treatment option in older patients suffering from atraumatic massive cuff tears,7 but some have found its results unpredictable.8 Similarly, outcomes from subacromial decompression and partial repair are not optimal, and benefits are temporary. These can best be considered as ‘limited goals’ procedures.9,10 Tendon transfers are associated with donor site morbidity, lengthy rehabilitation and modest gains. Also, massive cuff tears with subscapularis involvement cannot be treated with a single transfer. Latissimus dorsi transfers11 have traditionally been used for postero-superior cuff deficiency, but more recently lower trapezius transfers have also been described.12 Pectoralis major transfers, on the other hand, are commonly utilised for subscapularis defects13 with a modified latissimus dorsi transfer being described recently.14 Reverse shoulder replacements are certainly an option in the elderly, but there are concerns around longevity in the younger age group.15 More recently, there has been increasing interest in using two types of grafting procedures for the treatment of irreparable rotator cuff tears. These include interposition grafting16 and superior capsular reconstruction SCR.17

Interposition acellular matrix grafts serve to bridge the defect between the torn tendon and greater tuberosity when cuff mobilisation and or partial repair have failed to restore the cuff to its footprint anatomically. They offer mechanical strength and biological properties by serving as a scaffold for cellular and vascular ingrowth and collagen formation during the reconstruction of large to massive rotator cuff defects.

The main aim is to restore the rotator cuff's dynamic restraint to the superior translation of the humeral head. It is performed by suturing the graft material to the residual rotator cuff's lateral margin and the rotator cuff footprint on the proximal humerus. It can either be an open or arthroscopic procedure using various graft materials including autografts, allografts, xenografts or synthetic options. Graft augmentation can provide mechanical integrity during the early phase of healing and serve as a scaffold for cell migration and collagenous matrix production. Currently, none of the graft options come close to resembling the highly organised tendon structure - mechanically or biologically. In SCR, the graft is anchored medially to the superior glenoid and laterally to the rotator cuff footprint with no scope for graft integration with the cuff remnant. This review aims to provide an overview of available graft options (Fig. 1) and reported patient outcomes following interposition grafting (Where the graft is used for bridging rather than as an augment) for irreparable RCTs.

Fig. 1.

Fig. 1

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Available graft options for use in interposition grafting in irreparable rotator cuff tears.

2. Methods

The Cochrane controlled register of Trials (CENTRAL), Medline, Embase, CINAHL and PubMed databases were used to perform a systematic review with the following search terms: (“rotator cuff.” “tear,” “Massive,” “Irreparable,” “Allograft”) from their inception to September 4, 2020. Research or clinical research papers were included for human subjects in the English language.

Eligibility criteria included adults with large and massive rotator cuff tears treated with an interposition graft for an irreparable large or massive rotator cuff tear. DeOrio and Cofield's18 classification was used to classify large (3–5 cm) and massive (>5 cm) rotator cuff tears. Due to the heterogeneity in descriptions of large and massive tears in the current literature, we also accepted the involvement of 2 or more tendons and authors descriptions of “large” or “massive” cuff tears. Interposition grafting or bridging reconstruction is used when a defect cannot be closed following mobilisation and partial repair (if possible) of the torn and retracted tendon. We included human studies that reported on clinical and or radiological outcomes following interposition grafting for irreparable cuff tears. Interposition grafts were either an allograft, autograft, xenograft or synthetic. Both open and arthroscopic techniques were included. Rotator cuff tears without using a graft, repairs with muscle-tendon transfers and graft augmentation techniques where a primary repair was performed were excluded. Title and abstract reviews were performed before full-text reviews. We included studies that met the inclusion criteria above. Data was extracted from all included studies and added to a spreadsheet. The following variables were extracted from included studies: first author, year of publication, graft material, number of patients, surgical technique, shoulder scores, pain scores and imaging results, and length of follow up. Studies were separated according to graft type (Allograft, Autograft, Xenograft or Synthetic).

2.1. Allografts

Extracellular matrix allografts provide a collagen scaffold to promote the integration of local cells. They have limited mechanical properties and traces of cellular content can remain, thereby raising the theoretical risk of disease transmission and adverse inflammatory response.

GraftJacket is a human acellular dermal matrix graft which has a collagen matrix with intact vascular channels. Bond et al.19 were the first to publish outcomes of an arthroscopic technique using GraftJacket as an interposition allograft for massive irreparable tears. They followed up 16 patients and in the short term found that mean UCLA score increased from 18.4 to 30.4 and Constant score from 53.8 to 84.0 (P = 0.0001). MRI scans showed 13 out of the 16 grafts were intact, and 15 out of the 16 patients were satisfied with their treatment. Wong et al.16 as part of the same group updated their study to include 45 patients in 2010 and showed UCLA scores increased from 18.4 to 27.5 at 2 years follow up (P = 0.0001).

Most other groups have published variations of an open technique in order to perform interposition grafting. Modi et al.20 in a prospective study reviewed 61 patients treated using a GraftJacket allograft for irreparable tears where the graft was used to bridge the defect. They showed significant improvements in the Oxford Shoulder Score (OSS), ROM and strength at mean 3.6 years. The OSS improved from 26.4 to 44.6 (p < 0.01) after surgery, and pain score from 7 preoperatively to less than 1 at follow-up. Follow up imaging was not available for all patients, but histological analysis performed on a biopsy specimen taken arthroscopically from a patient with persistent clicking showed host cells within the allograft, suggesting integration. The authors have carried out a long term follow-up of this same cohort (unpublished data, 2021). The improvement in OSS to 42 at 1 year-post surgery was maintained at 9.1 years (range 7 years–12.5 years) with a score of 42.8 (P = 0.0001). Similar improvements in the pain score were seen and maintained at final follow up. There was a significant improvement in all shoulder movements, and patient satisfaction was high. No differences in outcome were observed based on tear size and Hamada grading. There were no graft rejections, and no patients have required revision surgery or conversion to a reverse shoulder replacement.

The senior author (AM) has recently reported the use of the GraftJacket for massive irreparable cuff tear without arthritis in the elderly as a possible alternative to reverse shoulder arthroplasty in 21 patients over the age of 68 with a mean follow up of 6.8 years. Statistically significant (p < 0.05) improvements were observed in the OSS from a mean pre-operative score of 21 to post-operative score of 46. Pain score improved from 6 preoperatively to 1 postoperatively. Patients also reported a high satisfaction rate with the procedure.21

Gupta et al.22 treated 24 patients using an open interposition GraftJacket technique and showed ASES scores increased from 66.6 to 88.7 (P = 0.0003). The repair was intact in 76% of patients on follow up ultrasonography and partially torn in the rest.

Venouziou et al.23 and Sharma et al.24 have shown significant improvements in outcomes following open reconstructions. Kokkalis et al.25 also treated 21 patients with a similar technique showing an improvement in the ASES score from 25.2 to 74.2 and a reduction in pain VAS score from 7.6 to 1.8. The main limitation with these three studies was a lack of follow up imaging, so it is unclear how many of their repairs were intact at follow up.

Pandey et al.26 in 2017 published a non-randomised cohort study comparing 13 patients with irreparable cuff tears treated with partial repair and another 13 patients treated with partial repair and Graft Jacket interposition. They showed that both procedures led to improved pain and function at 2 years, but there was a greater improvement in both Constant and OSS scores in the Graft Jacket group compared to partial repair alone. Follow up imaging showed that 3 out of the 10 patients in the interposition graft group sustained a re-tear, but their functional scores were unaffected.

Dimitrios et al.27 reported 68 patients treated with irreparable rotator cuff tears with an open technique using interposition fascia lata allografts. They reported an increase in Constant score from 32.5 preoperatively to 88.7. Once again, imaging was not available for all patients, and they concluded that MRIs were unreliable when assessing integrity of interposition grafts. Instead, they are suggesting ultrasound (US) be the modality of choice. They performed 30 US scans and found a re-tear rate of 10%.

Agrawal28 followed up 14 patients with large or massive cuff tears and a previously failed cuff repair using an allogenic matrix made from harvested human fascia (AlloPatch Pliable, Musculoskeletal Tissue Foundation). They found 12 intact repairs out of 14 on MRI at 16.8 months and a significant improvement in Constant score, pain score, movement and strength.

2.2. Autografts

Interposition with autografts is less commonly performed when compared to allografts. Mori et al.29 in 2013, found improved clinical outcomes following interposition fascia lata autografts over partial repairs for those patients with irreparable cuff tears and low-grade fatty atrophy according to Goutallier's staging. They then performed a more extensive study and reviewed results of interposition fascia lata autografts based on grade of infraspinatus fatty infiltration.30 They found that both groups had improved shoulder function and range of motion, but those patients from a lower grade had a much lower incidence of re-tear (8.3% compared to 89.4% in those with high-grade fatty degeneration) and more predictable improvements in function. A small case series by Mihara31 was published in 2016 with 5 patients being treated with an iliotibial band interposition graft with a bone block from the Gerdy's tubercle. This led to an improvement in pain and function, but not range of motion. Imaging showed that all repairs were intact at follow-up, but the study's small size does limit its importance.

Boutsiadis et al.33 introduced an SCR modification using the long head of biceps transfer (LHBT) technique. The tendon insertion into the glenoid is left intact, while laterally, it is tenotomised, and transferred onto the supraspinatus tendon's footprint and fixed with anchors thereby acting as a superior static stabiliser of the shoulder joint.

Cho et al.34 used a biceps tendon autograft to provide interposition autografts. They compared 37 patients treated with biceps tendons as autografts, with 31 treated with repairs under tension. They followed up 21 patients with clinical outcome scores and showed that constant scores and UCLA scores increased in both groups with no significant differences. The re-tear rate in a select group of patients was found to be lower in the augmentation group. The repair technique was used in addition to partial repairs, but is only applicable to small defects.

2.3. Xenografts

Neumann et al.35 used porcine dermal xenografts in 61 irreparable rotator cuff tears at a mean follow up of 50.3 months. Pain scores improved from 4 to 1 with an accompanying improvement in the ASES score. They showed that graft integrity was 91.8% on US. Their particular xenograft has been withdrawn from the market after the merger of Wright Medical and Tornier.

Badhe et al.36 described an open interposition technique using the Zimmer Collagen Repair Patch (ZCR, also known as Permacol), which is an acellular sheet of cross-linked porcine dermis. They reported favourable results in 10 patients with an improvement in Constant scores from 42 preoperatively to 62 at mean 4.5 years, improvement in post-operative pain and range of motion. Grafts were intact at follow up imaging in 8 out of 10 patients, and no adverse effects reported.

Gupta et al.37 also used a porcine dermal xenograft (Conexa Reconstructive Tissue Matrix, Tornier) as an interposition graft using a mini-open technique for irreparable RCTs in 27 shoulders. Mean ASES score improved from 62.7 to 91.8 (P = 0.0007) and mean SF-12 scores improved from 48.4 to 56.6 (P = 0.044). Sixteen out of the 21 patients that returned for follow up imaging had intact repairs. They had no cases of infection or rejection. It is important to note that although direct comparisons have not been made in the literature, their technique using xenografts was similar to their outcomes published for dermal allografts.

Iannotti et al.38 randomised thirty shoulders with a chronic two-tendon rotator irreparable cuff tears treated with either augmentation or no augmentation. They used Restore Orthobiologic Implant (DePuy Synthes) which is an acellular, non–cross-linked collagen-based patch made from porcine small intestine mucosa. The outcomes were inferior in the graft augmented group with high re-tear rates, less range of movement and post-operative inflammation.

Lamas et al.39 reported abandonment of a Level 1 trial for rotator cuff augmentation using a Xenograft following pathological immune response consisting of chronic synovitis and granulomatous lesions in 4 of their first 13 patients. Studies have shown a high proportion of severe immunogenic inflammatory reactions following the use of Xenografts made from porcine intestinal submucosa and their use is not recommended.40

2.4. Synthetic grafts

Various non-degradable and degradable synthetic grafts have been used for rotator cuff reconstruction without any consistent outcomes. Non-degradable patches require good strength and tissue compatibility. Various materials, including polycarbonate polyurethane, polytetrafluoroethylene, and polyester, have been used. These materials are processed into foam or felt allowing cells to penetrate the surface and incorporate. They lose structural integrity over time, and fragmentation can lead to mechanical failure or chronic inflammation. Polyurethane scaffolds have been demonstrated to provide initial mechanical integrity at the tendon-bone insertion site and act as a conductive scaffold for tendon ingrowth after rotator cuff repair in an ovine model.41

Degradable polyester scaffolds made of poly-l-lactide, polycaprolactone and polydioxanone have been studied as an interposition device in animal models. Stem cells, matrix proteins and growth factors can be delivered within these patches. They have limited structural strength, and there are concerns regarding persistent polyester debris following degradation. Also, their small pore size limits cell ingrowth.

Proctor et al.42 reported that 15 out of 18 patients with massive rotator cuff tears reinforced with the poly(l-lactide) patch (X-Repair, Synthasome), had intact repairs at 12 months on ultrasonography. ASES scores improved from 25 to 71 by 12 months (P = 0.03). Audenaert et al.43 used a Mersilene mesh (Ethicon, Inc., Somerville, NJ) in an open technique with subacromial decompression to bridge irreparable cuff tears. At a mean follow up of 43 months Constant score increased from 25.7 preoperatively to 72.1 postoperatively (P < 0.001). Three patients suffered a re-tear at the mesh-musculotendinous junction. They also showed significant improvements in abduction, forward elevation and strength. Nada et al.44 used a synthetic polyester ligament (Dacron) in 21 patients and showed a significant (P < 0.001) improvement in Constant score from 46.7 to 85.4 at 36 months. They performed MRI scans for 17 of their patients and found one had re-torn. One patient required removal of the synthetic ligament and washout for infection.

2.5. Specialist practice report

The two options reported for management massive irreparable cuff tears - interposition grafts and superior capsule reconstruction, aim to restore joint function. SCR literature offers a variety of surgical techniques with very little quantitative data.

Acellular dermal matrix grafts are biomaterials capable of bridging defects in massive irreparable rotator cuff tears and minimising graft rejection risk. The senior author's (AM) personal preference uses acellular dermal matrix grafts (Graft Jacket) as a bridging/interposition graft for massive irreparable cuff tears and has used this technique for the past 14 years with good outcomes reported. The unpublished long term results suggest that good outcomes at one year are sustained at 9.1 years post-reconstruction. There have been no rejections in over 250 cases done by the senior author over the past 14 years. This appears to be a safe and effective technique for bridging massive tears and current literature suggests these grafts are well tolerated.

High quality evidence in the form of Level 1 studies are lacking, and most reports are Level 3 and 4 studies. The existing literature includes outcomes following various graft materials, but have mostly compared post-operative outcomes with pre-operative scores.

All grafts are not the same as they vary in their mechanical and biological properties. The biological properties are influenced by how these grafts are processed and sterilised. Gamma irradiation for sterilisation results in scarring and collapse of vascular channels. Patency of these channels is essential for host cell infiltration and vascularisation. GraftJacket appears to be well tolerated with no reports of immunogenic reactions. The original graft was a clean graft and replaced in 2020 by GraftJacket NOW, a sterile graft. The vascular channels are still patent with the new processing technique, but studies will be required to show if the change in the graft processing can match or better the results of the original graft.

Superior capsule reconstruction (SCR) can potentially restore the force couples necessary for dynamic shoulder function. Biomechanical studies32 have shown that the superior capsule is a critical static stabiliser of the glenohumeral joint allowing the deltoid and pectoralis major to function properly. Reconstruction of the superior capsule with a collagen graft, attached medially to the superior glenoid and laterally to the greater tuberosity, was shown to restore the superior capsule to physiological conditions in a cadaveric model. To bridge the gap in the superior capsule, Mihata et al.17 initially proposed an SCR technique using folded fascia lata. This requires a large donor site incision for harvesting the graft, and alternative SCR techniques have been investigated using allografts, xenografts and synthetic grafts.

The issue with SCR is that the graft is fixed to 2 bony points and acts as a canopy over the humeral head. There is little opportunity to integrate with the remnant cuff and is a matter of time before it will tear. In contrast, an interposition/bridging graft is attached to the retracted cuff's remnant and fixed laterally to the footprint. There is scope for the host tissue to infiltrate the graft and get incorporated. This has been demonstrated in graft - host tendon histology obtained at post-operative arthroscopy.

Porcine xenografts have had conflicting results. Allogenic reactions have been seen with the porcine intestinal submucosal grafts, and the results of the dermal xenografts appear to be more acceptable. However, individual patient groups may find it objectionable on religious grounds to have a porcine graft implanted when other graft options are available, as highlighted when the authors carried out a patient consultation meeting. More recent results with the use of fascia lata allografts are encouraging.

Very few human studies have investigated synthetic grafts’ efficacy in repairing large to massive rotator cuff tears, and the numbers involved are too small to make any judgement. Implanting synthetic foreign bodies raises biocompatibility concerns increasing the risk of synovitis, osteolysis and foreign body reactions to the degradation particles.

Nanofibers are considered ideal for tendon tissue engineering with their ability to mimic biology. Electrospun scaffolds can be engineered to create sheets of aligned anisotropic polymer fibres for augmenting rotator cuff repair. They can be used as vehicles to deliver stem cells and growth factors.

3. Conclusions

Currently, there are no published long term results for the use of any of these grafts. The search continues for the ideal graft. Targeted research areas would be aimed at developing a degradable scaffold provides mechanical strength which can be combined with stem cells, growth factors and matrix proteins for host tissue integration.

In the more elderly population with symptomatic massive irreparable cuff tears, reverse shoulder arthroplasty is the consensus answer. With the younger patient, use of human extracellular dermal matrix graft is an option. However, the clinical results of these grafts are variable, and data on their long term efficacy is still lacking. Biologic based strategies to provide predictable healing and integration of the ideal graft, including gene and cell stem therapy may unlock this complex problem in the future. Randomised controlled studies are required for comparing the extracellular matrix grafts and synthetic grafts to determine their efficacy in providing mechanical strength and biological properties necessary for useful rotator cuff function.

CRediT author statement

Aziz Haque: Data curation, Writing- Original draft preparation.

Amit Modi: Conceptualization, Methodology, Writing, Reviewing and Editing.

Declaration of competing interest

Aziz Haque: None.

Amit Modi: Amit Modi has been a Consultant for Wright Medical for Surgical Visitations from 2016 to 2019.

Contributor Information

Aziz Haque, Email: aziz.leicester@googlemail.com.

Amit Modi, Email: amitmodi@nhs.net.

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