Human dermal matrix scaffold augmentation for large and massive rotator cuff repairs: preliminary clinical and MRI results at 1-year follow-up

Abstract

The high incidence of recurrent tendon tears after repair of massive cuff lesions is prompting the research of materials aimed at mechanically or biologically reinforcing the tendon. Among the materials studied upto now, the extracellular matrix (ECM) scaffolds of human origin have proved to be the safest and most efficient, but the current laws about grafts and transplants preclude their use in Europe. In order to overcome this condition in 2006, we started a project regarding the production of an ECM scaffold of human origin which could be implanted in Europe too. In 2009, the clinical study began with the implantation of dermal matrix scaffolds in 7 middle-aged patients affected with large/massive cuff lesions and tendon degeneration. Out of 5 cases, followed for at least 1 year in which the scaffold was employed as an augmentation device, there were 3 patients with complete healing, 1 partial re-tear, and 1 total recurrence. The absence of adverse inflammatory or septic complications allows to continue this line of research with a prospective controlled study in order to define the real advantages and correct indications offered by scaffold application.

Patch Augmentation for Massive Rotator Cuff Tears

“…28) And the fact that many studies do not include control groups makes it difficult to conduct comparative analyses (Table 2). 17,19,[29][30][31][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47] Studies that compare outcomes of graft augmentation with those of other control surgical techniques, such as the conventional repair technique, are summarized in Table 3. 27,28,32,46,[48][49][50] In almost all studies, whichever graft was used, clinical parameters, such as range of motion, the American Shoulder and Elbow Surgeons Evaluation Form (ASES) score, the University of California-Los Angeles (UCLA) score, and the Constant score significantly improved with patch augmentation.…”

“…11,17) Patch grafts are de-cellularized freeze-dried human cadaveric material consisting of collagen type I, II, IV, and VII, elastin, chondroitin sulfate, proteoglycans, and fibroblast growth factors and has in it preserved basement membrane and vascular channels, two constituents which have been shown to help host incorporation. 18,19) However, well-designed and longterm studies that investigate the mechanism of patch grafts and their effects are limited. And the possibility of remnant allogenic proteins within the scaffolds means that inflammatory responses may occur and cause tissue degeneration.…”

Rotary Hood Massive Break Solutions? Massive Rotator Cuff Tear Solutions?

“…They can be divided into two major groups: synthetic and biological. Biologicals may further be subdivided into autologous (long portion of the biceps) or allografts (derived from the dermis or submucosa of the small intestine) [2,43,44]. Discontinuation or moderation of the use of synthetic and submucosal grafts has been recommended because of the risk of inflammatory response and foreign body reaction [2,10,44,45].…”

Biologic and Tissue Engineering Strategies for Tendon Repair

“…Scaffolds have been shown to improve the mechanical properties of repaired tendons [114][115][116][117][118][119][120][121], so several studies have investigated artificial scaffolds and stem cell treatments in conjugation. Kim et al, investigating the viability of seeded stem cells, repaired full-thickness window defects of the infraspinatus tendon of 50 rabbits with MSC-seeded or unseeded open-cell PLA fiber scaffolds.…”