Amit Aurora

Scaffold devices for rotator cuff repair

Rotator cuff tears affect 40% or more of those aged older than 60 years, and repair failure rates of 20% to 70% remain a significant clinical challenge. Hence, there is a need for repair strategies that can augment the repair by mechanically reinforcing it, while at the same time biologically enhancing the intrinsic healing potential of the tendon. Tissue engineering strategies to improve rotator cuff repair healing include the use of scaffolds, growth factors, and cell seeding, or a combination of these approaches. Currently, scaffolds derived from mammalian extracellular matrix, synthetic polymers, and a combination thereof, have been cleared by the U.S. Food and Drug Administration and are marketed as medical devices for rotator cuff repair in humans. Despite the growing clinical use of scaffold devices for rotator cuff repair, there are numerous questions related to their indication, surgical application, safety, mechanism of action, and efficacy that remain to be clarified or addressed. This article reviews the current basic science and clinical understanding of commercially available synthetic and extracellular matrix scaffolds for rotator cuff repair. Our review will emphasize the host response and scaffold remodeling, mechanical and suture-retention properties, and preclinical and clinical studies on the use of these scaffolds for rotator cuff repair. We will discuss the implications of these data on the future directions for use of these scaffolds in tendon repair procedures.

The biomechanical role of scaffolds in augmented rotator cuff tendon repairs.

BACKGROUND Scaffolds continue to be developed and used for rotator cuff repair augmentation; however, the appropriate scaffold material properties and/or surgical application techniques for achieving optimal biomechanical performance remains unknown. The objectives of the study were to simulate a previously validated spring-network model for clinically relevant scenarios to predict: (1) the manner in which changes to components of the repair influence the biomechanical performance of the repair and (2) the percent load carried by the scaffold augmentation component. MATERIALS AND METHODS The models were parametrically varied to simulate clinically relevant scenarios, namely, changes in tendon quality, altered surgical technique(s), and different scaffold designs. The biomechanical performance of the repair constructs and the percent load carried by the scaffold component were evaluated for each of the simulated scenarios. RESULTS The model predicts that the biomechanical performance of a rotator cuff repair can be modestly increased by augmenting the repair with a scaffold that has tendon-like properties. However, engineering a scaffold with supraphysiologic stiffness may not translate into yet stiffer or stronger repairs. Importantly, the mechanical properties of a repair construct appear to be most influenced by the properties of the tendon-to-bone repair. The model suggests that in the clinical setting of a weak tendon-to-bone repair, scaffold augmentation may significantly off-load the repair and largely mitigate the poor construct properties. CONCLUSIONS The model suggests that future efforts in the field of rotator cuff repair augmentation may be directed toward strategies that strengthen the tendon-to-bone repair and/or toward engineering scaffolds with tendon-like mechanical properties.

Reinforced fascia patch limits cyclic gapping of rotator cuff repairs in a human cadaveric model

BACKGROUND Scaffolds continue to be developed and used for rotator cuff repair augmentation, but clinical or biomechanical data to inform their use are limited. We have developed a reinforced fascia lata patch with mechanical properties to meet the needs of musculoskeletal applications. The objective of this study was to assess the extent to which augmentation of a primary human rotator cuff repair with the reinforced fascia patch can reduce gap formation during in vitro cyclic loading. MATERIALS AND METHODS Nine paired human cadaveric shoulders were used to investigate the cyclic gap formation and failure properties of augmented and non-augmented rotator cuff repairs with loading of 5 to 180 N for 1000 cycles. RESULTS Augmentation significantly decreased the amount of gap formation at cycles 1, 10, 100, and 1000 compared with non-augmented repairs (P < .01). The mean gap formation of the augmented repairs was 1.8 mm after the first cycle of pull (vs 3.6 mm for non-augmented repairs) and remained less than 5 mm after 1000 cycles of loading (4.7 mm for augmented repairs vs 7.3 mm for non-augmented repairs). Furthermore, all augmented repairs were able to complete the 1000-cycle loading protocol, whereas 3 of 9 non-augmented repairs failed before completing 1000 loading cycles. CONCLUSIONS This study supports further investigation of reinforced fascia patches to provide mechanical augmentation, minimize tendon retraction, and possibly reduce the incidence of rotator cuff repair failure. Future investigation in animal and human studies will be necessary to fully define the efficacy of the reinforced fascia device in a biologic healing environment.

Mechanical characterization and biocompatibility of a novel reinforced fascia patch for rotator cuff repair

To provide mechanical augmentation for rotator cuff repair, it is necessary (though perhaps not sufficient) that scaffolds have tendon-like material and suture retention properties, be applied to the repair in a surgically appropriate manner, and maintain their mechanical properties for an acceptable period of time following surgery. While allograft fascia lata has material, structural, and biochemical properties similar to tendon tissue, its poor suture retention properties abrogates its potential as an augmentation device. The goal of this work was to design a novel reinforced fascia patch with suture retention and stiffness properties adequate to provide mechanical augmentation for rotator cuff repair. Fascia was reinforced by stitching with PLLA or PLLA/PGA polymer braids. Reinforced fascia patches had a maximum construct load greater than (or equal to) the suture retention properties of human rotator cuff tendon (∼250N) at time zero and after in vivo implantation for 12 weeks in a rat subcutaneous model. The patches were able to withstand the 2500 loading cycles projected for the early post-operative period. The patches also demonstrated biocompatibility with the host using a rat abdominal wall defect model. These studies suggest the potential use of reinforced fascia patches to provide mechanical augmentation, minimize tendon retraction and possibly reduce the incidence of rotator cuff repair failure.

An Analytical Model for Rotator Cuff Repairs

BACKGROUND Currently, natural and synthetic scaffolds are being explored as augmentation devices for rotator cuff repair. When used in this manner, these devices are believed to offer some degree of load sharing; however, no studies have quantified this effect. Furthermore, the manner in which loads on an augmented rotator cuff repair are distributed among the various components of the repair is not known, nor is the relative biomechanical importance of each component. The objectives of this study are to (1) develop quasi-static analytical models of simplified rotator cuff repairs, (2) validate the models, and (3) predict the degree of load sharing provided by an augmentation scaffold. METHODS The individual components of the repair constructs were modeled as non-linear springs, and the model equations were formulated based on the physics of springs in series and parallel. The model was validated and used to predict the degree of load sharing provided by a scaffold. Parametric sensitivity analysis was used to identify which of the component(s)/parameter(s) most influenced the mechanical behavior of the augmented repair models. FINDINGS The validated models predict that load will be distributed approximately 70-80% to the tendon repair and approximately 20-30% to the augmentation component. The sensitivity analysis suggests that the greatest improvements in the force carrying capacity of a tendon repair may be achieved by improving the properties of the bone-suture-tendon interface. Future studies will perform parametric simulation to illustrate the manner in which changes to the individual components of the repair, representing different surgical techniques and scaffold devices, may influence the biomechanics of the repair construct.

A Biomechanical Model for Augmented Human Rotator Cuff Repairs

Rotator cuff tears affect 40% or more of those over age 60 and are a common cause of pain and disability. Surgical repairs have high failure rates that range from 20 to 90%. Hence, natural and synthetic scaffolds are being developed to mechanically augment tendon repairs and to biologically enhance the intrinsic healing potential of the patient. When used as an augmentation device, scaffolds are believed to provide some degree of load sharing in a manner that decreases the likelihood of tendon re-tear. While significant advances are being made in the development of scaffolds, no studies have investigated the degree of load sharing provided by a scaffold used for rotator cuff repair augmentation. Furthermore, the manner in which loads on an augmented rotator cuff repair are distributed amongst the various components of the repair is not known, nor is the relative biomechanical importance of the various components of the repair. To answer these questions, the objectives of this study are to (1) develop quasi-static analytical models of simplified rotator cuff repairs, (2) validate the models by comparing the predicted model force to experimental measurements of force for human rotator cuff repairs, and (3) use the models to predict the degree of load sharing provided by a scaffold used for rotator cuff repair augmentation.Copyright