Jesse A. McCarron

Rotator cuff repair augmentation in a canine model with use of a woven poly-L-lactide device.

BACKGROUND Despite advances in surgical treatment options, failure rates of rotator cuff repair have continued to range from 20% to 90%. Hence, there is a need for new repair strategies that provide effective mechanical reinforcement of rotator cuff repair as well as stimulate and enhance the intrinsic healing potential of the patient. The purpose of this study was to evaluate the extent to which augmentation of acute repair of rotator cuff tendons with a newly designed poly-L-lactide repair device would improve functional and biomechanical outcomes in a canine model. METHODS Eight adult, male mongrel dogs (25 to 30 kg) underwent bilateral shoulder surgery. One shoulder underwent tendon release and repair only, and the other was subjected to release and repair followed by augmentation with the repair device. At twelve weeks, tendon retraction, cross-sectional area, stiffness, and ultimate load of the repair site were measured. Augmented repairs underwent histologic assessment of biocompatibility. In addition, eight pairs of canine cadaver shoulders underwent infraspinatus injury and repair with and without device augmentation with use of identical surgical procedures and served as time-zero biomechanical controls. Eight unpaired, canine cadaver shoulders were included as normal biomechanical controls. RESULTS At time zero, repair augmentation significantly increased the ultimate load (23%) (p = 0.034) but not the stiffness of the canine infraspinatus tendon repair. At twelve weeks, the poly-L-lactide scaffold was observed to be histologically biocompatible, and augmented repairs demonstrated significantly less tendon retraction (p = 0.008) and significantly greater cross-sectional area (137%), stiffness (26%), and ultimate load (35%) than did repairs that had not been augmented (p < 0.001, p = 0.002, and p = 0.009, respectively). CONCLUSIONS While limiting but not eliminating tendon repair retraction, the augmentation device provided a tendon-bone bridge and scaffold for host tissue deposition and ingrowth, resulting in improved biomechanical function of the repair at twelve weeks.

Predicting normal glenoid version from the pathologic scapula: a comparison of 4 methods in 2- and 3-dimensional models.

BACKGROUND Correction of pathologic glenoid retroversion improves gleonhumeral mechanics and reduces glenoid component wear after total shoulder arthroplasty. Determining the amount of correction necessary can be difficult because of the wide range of normal glenoid version. We hypothesize that normal glenoid version can be predicted in a pathologic shoulder based on conserved relationships between the anterior glenoid wall, Resch angle, and the internal structures of the glenoid vault. MATERIALS AND METHODS Three-dimensional (3-D) computer tomography (CT) scan-based measurements of the anterior glenoid wall angle (AGWA), Resch angle (RA), and glenoid version were made in 58 scapulae from the Haeman-Todd Osteological Collection (Museum of Natural History in Cleveland, OH) and 19 paired scapulae from patients with unilateral osteoarthritis. Linear regression equations derived from the AGWA and RA and from a computer-generated vault model were used to predict native (nonpathologic) glenoid version as defined by the 19 nonpathologic scapula. RESULTS Linear regression equations based on the measured AGWA or RA, as well as the glenoid vault model in the 19 pathologic scapulae, were able to accurately predict native glenoid version in the contralateral nonpathologic shoulder. DISCUSSION This study demonstrates the ability to take 3-D CT scan-based measurements in a scapula with pathologic glenoid retroversion and predict the native (nonpathologic) glenoid version in the contralateral shoulder by using linear regression equations or a computer generated vault model. Such tools might assist in preoperative planning and intraoperative decision making to allow correction of pathologic glenoid retroversion.

Improved time-zero biomechanical properties using poly-L-lactic acid graft augmentation in a cadaveric rotator cuff repair model

HYPOTHESIS Rotator cuff repair failure rates range from 20% to 90%, and failure is believed to occur most commonly by sutures cutting through the tendon due to excessive tension at the repair site. This study was designed to determine whether application of a woven poly-L-lactic acid device (X-Repair; Synthasome, San Diego, CA) would improve the mechanical properties of rotator cuff repair in vitro. MATERIALS AND METHODS Eight pairs of human cadaveric shoulders were used to test augmented and non-augmented rotator cuff repairs. Initial stiffness, yield load, ultimate load, and failure mode were compared. RESULTS Yield load was 56% to 92% higher and ultimate load was 56% to 76% higher in augmented repairs. No increase in initial stiffness was found. Failure by sutures cutting through the tendon was reduced, occurring in 17 of 20 non-augmented repairs but only 7 of 20 augmented repairs. CONCLUSIONS Our data show that application of the X-Repair device significantly increased the yield load and ultimate load of rotator cuff repairs in a human cadaveric model and altered the failure mode but did not affect initial repair stiffness.

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.

The Biomechanical Relevance of Anterior Rotator Cuff Cable Tears in a Cadaveric Shoulder Model

BACKGROUND Anterior tears of the supraspinatus tendon are more likely to be clinically relevant than posterior tears of the supraspinatus. We hypothesized that anterior tears of the supraspinatus tendon involving the rotator cuff cable insertion are associated with greater tear gapping, decreased tendon stiffness, and increased regional tendon strain under physiologic loading conditions compared with equivalently sized tears of the rotator cuff crescent. METHODS Twelve human cadaveric shoulders were randomized to undergo simulation of equivalently sized supraspinatus tears of either the anterior rotator cuff cable (n = 6) or the adjacent rotator cuff crescent (n = 6). For each specimen, the supraspinatus tendon was cyclically loaded from 10 N to 180 N, and a custom three-dimensional optical system was used to track markers on the surface of the tendon. Tear gap distance, stiffness, and regional strains of the supraspinatus tendon were calculated. RESULTS The tear gap distance of large cable tears (median gap distance, 5.2 mm) was significantly greater than that of large crescent tears (median gap distance, 1.3 mm) (p = 0.002), the stiffness of tendons with a small (p = 0.002) or large (p = 0.002) cable tear was significantly greater than that of tendons with equivalently sized crescent tears, and regional strains across the supraspinatus were significantly increased in magnitude and altered in distribution by tears involving the anterior insertion of the rotator cuff cable. CONCLUSIONS These findings support our hypothesis that the rotator cuff cable, which is in the most anterior 8 to 12 mm of the supraspinatus tendon immediately posterior to the bicipital groove, is the primary load-bearing structure within the supraspinatus for force transmission to the proximal part of the humerus. Conversely, in the presence of an intact rotator cuff cable, the rotator cuff crescent insertion is relatively stress-shielded and plays a significantly lesser role in supraspinatus force transmission. CLINICAL RELEVANCE Clinicians should consider early repair of rotator cuff cable tears, which may need surgical intervention to address their biomechanical pathology. In contrast, surgical treatment may be more safely delayed for rotator cuff crescent tears.

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.

Estimation of Dynamic, In Vivo Soft-Tissue Deformation: Experimental Technique and Application in a Canine Model of Tendon Injury and Repair

Outcomes after rotator cuff surgery are typically assessed with measures of strength, joint motion, or pain, but these measures do not provide a direct assessment of tissue function as healing progresses. To address this limitation, this manuscript describes biplane X‐ray analysis as a technique for quantifying in vivo soft‐tissue deformation. Tantalum beads were implanted in the humerus and infraspinatus tendon in a canine model of tendon injury and repair. Biplane X‐ray images were acquired during treadmill trotting and tissue deformation was estimated from the three‐dimensional bead positions. Changes over time were characterized by the mean, range, and normalized range (i.e., range/mean) of interbead distance. Intact tendon repair tissue demonstrated significant decreases over time in the mean (p = 0.003), range (p = 0.001), and normalized range (p = 0.001) of interbead distance. Failed tendon repair tissue demonstrated significant decreases over time in the range (p = 0.05) and normalized range (p = 0.04) of interbead distance. In an uninjured control, differences over time in the interbead distance parameters were not detected. This approach is a promising technique for estimating changes over time in soft‐tissue deformation. These preliminary data indicate appreciable differences between normal tendons, intact repairs, and failed repairs.

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