Objectives

We hypothesise that a long-term bioresorbable hydrophilic silkworm silk device, the SeriACL(tm) scaffold, can support the development and remodelling of native functional ligament tissue if designed to anticipate the remodelling curve of an ACL graft. This study evaluated the SeriACL scaffold for ACL replacement in a goat model at 3, 6 and 12 months.

Objective: The high incidence of retear following primary rotator cuff tendon (RCT) repair necessitates new strategies for tendon footprint augmentation. This study’s objective was to evaluate the SeriCuff™, a non-mammalian derived silk-based long-term bioresorbable implant, for RCT footprint reinforcement. The study aimed to characterize the device when overlaid on the infraspinatus tendon footprint of sheep in a RCT repair model. The technique was not targeted for the repair of massive RCT defects but advocated as a preventive measure to cuff reruptures in mid-to-large cuff tears, avoiding the need for surgical revision.

Methods: Bilateral surgeries were performed on each of 10 sheep during a single surgical session. The right shoulder of each animal was implanted with SeriCuff and the left shoulder was used as an operated control. The superficial layer of the infraspinatus tendon was removed and feathered for a distance of 1 cm. The remaining footprint was bluntly dissected from the humeral head with the exception of a thin band of the superior portion of the infraspinatus tendon. The footprint was approximated, 3 suture anchors placed equi-distantly along the edge of the full thickness region of the tendon and the tendon sutured to the anchors with a modified Mason-Allen stitch. Two additional anchors were placed along the lateral edge of the tendon in the right shoulder. The SeriCuff device was positioned over the 5 anchors and sutured in place using a single suture at each location (Fig 1B). In the left shoulder, no device was implanted and a second row of anchors was not used. Animals were allowed to ambulate immediately post-op with unrestrained motion for the duration of the study. All animals were necropsied at 3 mos and evaluated histologically (N=4) and mechanically (N=6). Samples designated for mechanical analysis were dissected leaving only the infraspinatus tendon and muscle attached to the humorous. The tendon was pulled to failure at a rate of 500 mm/min with the sample positioned such that the longitudinal axis of the tendon was collinear with the applied load.

Results: The animals were able to ambulate following surgery with return to normal gait at an average of 6 days post-operatively. Pain scores diminished with time throughout the first two weeks. Mechanical analysis indicated an average 42% increase in repair strength of the SeriCuff reinforced repair as compared to the contralateral control at 3 months. The SeriCuff device supported the formation of Sharpy’s fibers in the remodeling tendon tissue.

Conclusions: The addition of SeriCuff helped to reestablish the tendon footprint resulting in significantly increased repair strength 3 most post-op and therefore may have applications in reducing the high incidence of primary repair failure.

Objectives: Advances in biomedical engineering have led to a thorough understanding of the body’s own capacity for ACL healing if provided the correct impetus—a long-term bioresorbable graft scaffold that anticipates the defect site’s biological and mechanical requirements. We hypothesize that by providing a structural scaffold which anticipates ACL repair mechanisms, “engineered” autologous ligament with excellent functional integrity can be developed by the body itself. This study evaluated the SeriACL™ graft, a non-mammalian derived long-term bioresorbable multi-bundled silk-based implant, for ACL replacement in a goat model at 3, 6 and 12 months post-operatively.

Methods: The ACL of 43 goats was replaced with the SeriACL graft in an arthroscopically assisted procedure. The ACL was excised, a guide pin driven into the femur and 6mm diameter antegrade drilling performed. The tibial tunnel was drilled under direct visualization. The SeriACL, designed to mimic hamstring grafts, was anchored around a post on the femur. The graft was tensioned to 50N and cycled 30x before tibial fixation with a staple and sutures around a post. Animals were clinically, mechanically and histomorphometrically evaluated at 3, 6 and 12 months.

Results: The SeriACL graft or surgical procedure did not induce early signs of acute inflammation, swelling or initial scar formation as indicated by rapidly declining scores for pain and knee size. All animals were weight bearing at 3, 6 and 12 months, with 95% returning to normal gait by 6 months. Lachmann showed the majority of knees were clinically stable at all points. Range of motion assessment indicated the knees maintained a normal range flexion and extension at all points. No gross cartilaginous damage, synovitis or particulate debris in lymph nodes was observed at any time point. Organized collagen and aligned fibroblasts in a crimp pattern were observed in the periphery of the ligament structure, adjacent to and attached to the remaining SeriACL device at all necropsy times. Collagen development throughout the graft and bone tunnels increased with time. Conversely, inflammation and device mass loss decreased with time. Fluoroscopy indicated no abnormal bone tunnel findings. Total plasma IgG levels did not increase from pre-surgery levels at any time. AP laxity indicated joint stability at all time points. Implant abrasion was observed to varying extents yet mechanical testing revealed tissue development supported increased load bearing over time.

Conclusions: Results clearly demonstrate the potential of a scaffold-first strategy in engineering viable autologous ACL tissue that may serve over the patient’s life time. The SeriACL graft supported autologous development of a mechanically robust, biologically viable ligament which stabilized the joint over a 12 mo period. Mechanical, clinical and histological results indicated the safety of the SeriACL with initial indications of efficacy. Thus, the implant may offer the potential of an ACL replacement graft without the deleterious side-effects associated with donor-site morbidity and allogenic and xenogenic grafts.