Rotator cuff repair with biological graft augmentation causes adverse tissue outcomes

Abstract

Background and purpose — Biological patches can be used to augment rotator cuff tendon repair in an attempt to improve healing and reduce rates of re-rupture. However, little is known about the in vivo tissue response to these patches. We assessed native rotator cuff tissue response after surgical repair and augmentation with 2 commercially available extracellular matrix (ECM) patches.

Patients and methods — Patients underwent a rotator cuff repair augmented with either GraftJacket (Wright Medical), Permacol (Zimmer Biomet), or no patch (Control), applied using an onlay technique. A sample of supraspinatus tendon was collected intraoperatively and 4 weeks post-surgery, using ultrasound-guided biopsy. Histology and immunohistochemistry were performed on all samples.

Results — The Permacol group (n = 3) and GraftJacket group (n = 4) demonstrated some changes in native tendon ECM compared with the control group (n = 3). Significant disruption of the extracellular matrix of the repaired native supraspinatus, underlying both patches, was observed. The patches did not generally increase cellularity, foreign body giant cell count, or vascularity compared to the control group. 1 patient in the Permacol group had an adverse tissue immune response characterized by extensive infiltration of IRF5⁺, CD68⁺, and CD206⁺ cells, suggesting involvement of macrophages with a pro-inflammatory phenotype. No significant differences in protein expression of CD4, CD45, CD68, CD206, BMP7, IRF5, TGFß, and PDPN were observed among the groups.

Interpretation — Histological and immunohistochemical analysis of native tendon tissue after patch augmentation in rotator cuff repair raises some concerns about a lack of benefit and potential for harm from these materials.

MSR, RS, SS, SGD, and AJC were involved in study design. KW and BW were involved in ethical approval application, patient recruitment, and coordination of tissue samples. AJC conducted all surgeries and ultrasound-guiding sample biopsies. MSR and NN conducted the histological and immunohistochemical experiments. SS, SGD, and AJC supervised the study. All authors were involved in the preparation and proof-reading of the manuscript.

Acta thanks Hanna Cecilia Björnsson Hallgren and Hans Rahme for help with peer review of this study.