Knotless Tendon Repair with a Resorbable Barbed Suture: An In-vivo Comparison in the Turkey Foot.

Background: Un-knotted barbed suture constructs are postulated to decrease repair bulk and improve tension loading along the entire repair site resulting in beneficial biomechanical repair properties. Applying this repair technique to tendons has shown good results in ex-vivo experiments previously but thus far no in-vivo study could confirm these. Therefore, this current study was conducted to assess the value of un-knotted barbed suture repairs in the primary repair of flexor tendons in an in-vivo setting. Methods: Two groups of 10 turkeys (Meleagris gallapovos) were used. All turkeys underwent surgical zone II flexor tendon laceration repairs. In group one, tendons were repaired using a traditional four-strand cross-locked cruciate (Adelaide) repair, while in group two, a four-strand knotless barbed suture 3D repair was used. Postoperatively repaired digits were casted in functional position, and animals were left free to mobilise and full weight bear, resembling a high-tension post-op rehabilitation protocol. Surgeries and rehabilitations went uneventful and no major complications were noted. The turkeys were monitored for 6 weeks before the repairs were re-examined and assessed against several outcomes, such as failure rate, repair bulk, range of motion, adhesion formation and biomechanical stability. Results: In this high-tension in-vivo tendon repair experiment, traditionally repaired tendons performed significantly better when comparing absolute failure rates and repair stability after 6 weeks. Nevertheless, the knotless barbed suture repairs that remained intact demonstrated benefits in all other outcome measures, including repair bulk, range of motion, adhesion formation and operating time. Conclusions: Previously demonstrated ex-vivo benefits of flexor tendon repairs with resorbable barbed sutures may not be applicable in an in-vivo setting due to significant difference in repair stability and failure rates. Level of Evidence: Level IV (Therapeutic).

Factors impacting informed consent in cosmetic breast augmentation.

BACKGROUND: For women who undergo cosmetic breast augmentation, their post-operative risk assessment may not match their pre-operative understanding of the involved risks and likelihood of revision surgeries. This may be due to the potential issues surrounding whether patients are being fully informed about all possible risks and related financial implications during the consent phases of patient/doctor consultation. METHODS: To explore comprehension, risk preference, and perceptions of breast augmentation procedure, we conducted a recorded online experiment with 178 women (18-40 years) who received varying amounts of risk-related information from two experienced breast surgeons in a hypothetical first consultation scenario. RESULTS: We find patient's age, self-rated health, income, education level, and openness to experience to be significant factors impacting initial breast augmentation risk preferences (before receiving any risk information). Further, more emotionally stable patients perceived greater breast augmentation risks, were less likely to recommend breast augmentation, and were more likely to acknowledge the likelihood for future revision surgery. After providing women with risk-related information we find increases in risk assessment in all treatment conditions, and that increased amounts of risk information do decrease women's willingness to recommend breast augmentation. But that increased risk information does not appear to increase women's assessment of the likelihood of future revision surgery. Finally, we find some participant individual differences (such as education level, having children, conscientiousness and emotional stability) appear to impact risk assessment post receiving risk information. CONCLUSION: Continuous improvement of the informed consent consultation process is vital to optimising patient outcomes efficiently and cost-effectively. Greater acknowledgement and emphasis on disclosure of related risks and financial burden when complications arise is also important. As such, future behavioural research is warranted into the factors impacting women's understanding both prior to and across the BA informed consent process.

Cyclic Testing of a Modified Pull-Out Suture Repair Technique for Flexor Digitorum Profundus Avulsion in a Turkey Foot Model.

Background: Numerous repair techniques have been described for closed flexor digitorum profundus (FDP) avulsion. One option is a pull-out suture tied over the nail plate (Bunnell repair). We modified the Bunnell repair by incorporating a portion of the distal interphalangeal (DIP) joint volar plate into the repair to improve strength and reduce gapping. The aim of this study is to compare gap formation and load to failure between the Bunnell repair and our modification in a turkey foot model. Methods: Twenty-four fresh-frozen cadaveric turkey feet were divided into two repair groups namely the conventional Bunnell pull-out suture technique and the modified Bunnell pull-out suture technique, incorporating the middle-third of the DIP joint volar plate into the repair. Both repairs were carried out with 3-0 prolene suture and underwent ex-vivo cyclic loading at 2-12 n in a sinusoidal wave for 100 cycles to simulate a passive range of motion (ROM) protocol. Subsequently, specimens were loaded to failure at 12 mm/minute. Gap formation and load to failure were measured. Results: No repair ruptures occurred during cyclical testing. Mean gap formation was 9.2 mm (±1.49) in the Bunnell repair, and 3.5 mm (±1.19) in the modified Bunnell repair (p < 0.0001). The mean load to failure for the Bunnell repair was 35.4 n compared to 45 n for the modified repair (p = 0.0017). Conclusions: Gap formation was reduced and load to failure increased by augmenting the Bunnell pull-out suture repair with the central portion of the DIP joint volar plate.

Cognitive Bias and Therapy Choice in Breast Reconstruction Surgery Decision-Making.

BACKGROUND: Understanding how medical experts and their patients process and transfer information is of critical importance for efficient health care provision. Behavioral economics has explored similar credence markets where economic incentives, information asymmetry, and cognitive bias can impact patient and surgeon choice. The aim of the current study is to explore how framing and behavioral bias affect elective restorative surgery decision-making, such as breast reconstruction following cancer treatment. METHODS: The authors' study uses a cross-sectional survey data set of specialist surgeons (n = 53), breast care nurses (n = 101), and former or current breast cancer patients (n = 689). Data collected include participant demographics, medical history, a battery of cognitive bias tests, and a behavioral framing experiment. RESULTS: This study finds statistically significant differences in breast reconstruction surgery preference by patients and nurses when decision options are framed in different ways (i.e., positively versus negatively). The authors' analysis of surgeons, nurses, and patients shows no statistically significant difference across eight common forms of cognitive bias. Rather, the authors find that the behavioral biases are prevalent to the same extent in each group. This may indicate that differences in experience and education seem not to mitigate biases that may affect patient choices and medical professional's recommendations. The authors' multivariate analysis identifies patient age (p < 0.0001), body mass index, and self-perceived health (p < 0.05) as negative correlates for choice of implant-based reconstruction. CONCLUSION: For surgeons, nurses, and patients, the authors find uniform evidence of cognitive bias; more specifically, for patients and nurses, the authors find inconsistency in preference for type of surgical therapy chosen when alternative procedures are framed in different ways (i.e., framing bias).

Exploring Surgeons', Nurses', and Patients' Information Seeking Behavior on Medical Innovations: The Case of 3D Printed Biodegradable Implants in Breast Reconstruction.

Objectives: To explore information seeking behavior on medical innovations. Background: While autologous and alloplastic options for breast reconstruction are well established, it is the advent of the combination of 3D printing technology and the biocompatible nature of a highly porous biodegradable implants that offers new treatment options for the future. While this type of prosthesis is not yet clinically available understanding how patients, surgeons, and nurses take up new medical innovations is of critical importance for efficient healthcare provision. Materials and Methods: Using the largest ever combined sample of breast cancer patients (n = 689), specialist surgeons (n = 53), and breast care nurses (n = 101), we explore participants preference for a new surgical treatment concept rooted in 3D printed and biodegradable implant technologies in the context of breast reconstruction. Results: We find that patients overwhelmingly favor information from a successful patient of the proposed new technology when considering transitioning. Surgeons and nurses instead favor regulatory body advice, peer-reviewed journals, and witnessing the procedure performed (either in person or online). But while 1 in 4 nurses nominated talking to a successful patient as an information source, not a single surgeon chose the same. Our multinomial logit analysis exploring patient preference (controlling for individual differences) showed statistically significant results for both the type of surgical treatment and choice to undergo reconstruction. Women who underwent a type of mastectomy procedure (compared with lumpectomy patients) were more likely to choose a former patient than a surgeon for seeking information relating to a new breast implant technology. Further, women who chose to undergo a reconstruction procedure, compared with those who did not, where more likely to prefer a surgeon for information relating to a new breast implant technology, rather than a successful patient. For medical professionals, we find no statistically significant relationship between medical professionals' preference and their age, nor the number of other medical professionals they work with daily, nor the average number of breast procedures performed in their practice on a weekly basis. Conclusions: As our findings show large variation exists (both within our patient group and compared with medical professionals) in where individuals favor information on new medical innovations, future behavioral research is warranted.

Biomechanical Principles of Breast Implants and Current State of Research in Soft Tissue Engineering for Cosmetic Breast Augmentation.

Currently there are limited implant-based options for cosmetic breast augmentation, and problems associated with those have been increasingly appreciated, most commonly capsular contracture, which occurs due to a chronic foreign body reaction against non-degradable implant materials such as silicone and polyurethane leading to scar tissue formation, pain, and deformity. The underlying biomechanical concepts with implants create a reciprocal stress-strain relationship with local tissue, whilst acting as a deforming force. This means that with time, as the implant continues to have an effect on surrounding tissue the implant and host's biomechanical properties diverge, making malposition, asymmetry, and other complications more likely. Research directed towards development of alternative therapies based on tissue engineering and regenerative medicine seeks to optimize new tissue formation through modulation of tissue progenitors and facilitating tissue regeneration. Scaffolds can guide the process of new tissue formation by providing both an implant surface and a three-dimensional space that promotes the development of a microenvironment that guides attachment, migration, proliferation, and differentiation of connective tissue progenitors. Important to scaffold design are the architecture, surface chemistry, mechanical properties, and biomaterial used. Scaffolds provide a void in which vascularization, new tissue formation, and remodelling can sequentially occur. They provide a conduit for delivery of the different cell types required for tissue regeneration into a graft site, facilitating their retention and distribution. Whilst recent research from a small number of groups is promising, there are still ongoing challenges to achieving clinical translation. This article summarizes the biomechanical principles of breast implants, how these impact outcomes, and progress in scaffold-guided tissue engineering approaches to cosmetic breast augmentation. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Use of Onlay Hydroxyapatite Cement for Secondary Cranioplasty.

BACKGROUND: Children who undergo bi-fronto-orbital advancement (BFOA) frequently develop a contour deformity on the temporal and supra-orbital region, with an incidence reported as high as 55% and 75%, respectively. Up to 20% of patients may require correction. Hydroxyapatite cement (HAC) is a good alternative to autogenous tissue. The available literature on its use focusses on the reconstruction of bone defects, but little has been published on its efficacy and safety as an onlay graft over intact cranium. OBJECTIVES: To describe our institution's experience with HAC in the pediatric population. METHODS: Retrospective chart review from 1998 to 2018 on all patients from the Craniofacial Unit at the Sydney Children's Hospital who had either coronal or metopic craniosynostosis and underwent BFOA and later in life required cranioplasty with HAC for contour repair. FINDINGS: We have performed 166 BFOA and nineteen secondary cranioplasties for contour repair using onlay HAC. The mean age at the time of operation was 14 years. Bi-coronal craniosynostosis was most frequently associated with secondary cranioplasty and 37% had an associated syndrome. The mean volume of HAC used was 37 mL. There was only 1 patient who had a complication (5.3%) and required partial removal of allograft. The mean length of admission was 2 days. Mean follow up time of 22.4 months. CONCLUSIONS: HAC represents a safe option when used correctly, with low rates of complication and satisfactory cosmetic outcomes.

Quantification of Head Shape and Cranioplasty Outcomes: Six-compartment Volume Method Applied to Sagittal Synostosis.

BACKGROUND: Premature fusion of the sagittal (midline) suture between 2 parietal bones is the most common form of craniosynostosis. Surgical correction is mandated to improve head shape and to decrease the risk of raised intracranial pressure. This study evaluated the utility of 3-dimensional (3D) imaging to quantify the volumetric changes of surgical correction. Currently there is no standardized method used to quantify the outcomes of surgery for craniosynostosis, with the cranial index (width: length ratio) being commonly used. METHODS: A method for quantification of head shape using 3D imaging is described in which the cranium is divided up into 6 compartments and the volumes of 6 compartments are quantified and analyzed. The method is size invariant, meaning that it can be used to assess the long-term postoperative outcomes of patients through growth. The method is applied to a cohort of sagittal synostosis patients and a normal cohort, and is used to follow up a smaller group of synostotic patients 1, 2, and 3 years postoperatively. RESULTS: Statistical analysis of the results shows that the 6-compartment volume quantification method is more accurate in separating normal from synostotic patient head shapes than the cranial index. CONCLUSIONS: Spring-mediated cranioplasty does not return head shape back to normal, but results in significant improvements in the first year following surgery compared with the preoperative sagittal synostosis head shape. 3D imaging can be a valuable tool in assessing the volumetric changes due to surgery and growth in craniosynstosis patients.

Animal Models for Tendon Repair Experiments: A Comparison of Pig, Sheep and Human Deep Flexor Tendons in Zone II.

BACKGROUND: This laboratory study compared pig, sheep and human deep flexor tendons in regards to their biomechanical comparability. METHODS: To investigate the relevant biomechanical properties for tendon repair experiments, the tendons resistance to cheese-wiring (suture drag/splitting) was assessed. Cheese-wiring of a suture through a tendon is an essential factor for repair gapping and failure in a tendon repair. RESULTS: Biomechanical testing showed that forces required to pulling a uniform suture loop through sheep or pig tendons in Zone II were higher than in human tendons. At time point zero of testing these differences did not reach statistical significance, but differences became more pronounced when forces were measured beyond initial cheese-wiring (2 mm, 5 mm and 10 mm). The stronger resistance to cheese-wiring was more pronounced in the pig tendons. Also regarding size and histology, sheep tendons were more comparable to human tendons than pig tendons. CONCLUSIONS: Differences in tendon bio-properties should be kept in mind when comparing and interpreting the results of laboratory tendon experiments.

Structural Failure Mechanisms of Common Flexor Tendon Repairs.

BACKGROUND: This study investigated the exact failure mechanisms of the most commonly used conventional tendon repair techniques. A new method, radiographing repair constructs in antero-posterior and lateral projections before and after tensioning was used. This allowed to precisely analyse failure mechanisms in regards to geometrical changes in all three dimensions. Additionally the biomechanical stability focusing on gapping was tested. METHODS: Sheep fore limb deep flexor tendons were harvested and divided in eight groups of ten tendons. Three common variants of the Kessler repair method and four common 4-strand repair techniques were tested. Additionally a new modification of the Adelaide repair was tested. RESULTS: Biomechanical testing showed no significant differences in gapping for the three tested 2-strand Kessler repair groups. Once a double Kessler or 4-strand Kessler repair was performed the stability of the repair improved significantly. Further significant improvements in biomechanical stability could be achieved by using cross locks in the repair like in the Adelaide repair method. Qualitative analysis using radiographs showed that all Kessler repair variants unfolded via rotations around the transverse suturing component, no matter which variant was used. CONCLUSIONS: Additional to the commonly described constriction of the repair construct, the rotating deformation is the main reason for repair site gapping in Kessler tendon repair methods. The term "locking" in a Kessler repair is misleading. The cruciate repairs tended to loose grip and drag (cheese-wire) through the tendon and therefore lead to gapping. The most stable repair constructs in all three dimensions were the Adelaide repair and its interlocking modification. This is due to the superior anchoring qualities of its cross locks and three dimensional stability.

The Interlocking Modification of the Cross Locked Cruciate Tendon Repair (Modified Adelaide Repair): A Static and Dynamic Biomechanical Assessment.

The 4-strand cross-locked cruciate flexor tendon repair technique (Adelaide technique) has been shown to have comparably high resistance to gap formation and ultimate tensile strength. This study aimed to determine whether an interlocking modification to the Adelaide repair would impart improved biomechanical characteristics. Twenty four sheep flexor tendons were harvested, transected and repaired using either standard or modified Adelaide techniques. Repaired tendons were cyclically loaded. Gap formation and ultimate tensile strength were measured. Additionally, suture exposure on the tendon surface was determined. There was a statistically significant increase in resistance to gap formation in the early phase of cyclic loading within the modified Adelaide group. In the later stages of testing no significant difference could be noted. The average final load to failure in the modified group was higher than the standard group but this did not achieve statistical significance. Interlocking suture techniques in four strand tendon repair constructs can improve gapping behavior in the early phase of cyclic loading.

Influence of locking stitch size in a four-strand cross-locked cruciate flexor tendon repair.

PURPOSE: The 4-strand cross-locked cruciate technique (Adelaide technique) for repairing flexor tendons in zone II is a favorable method in terms of strength and simplicity. The purpose of this study was to investigate the effects of varying the cross-lock stitch size in this repair technique. Outcomes measured were load to failure and gap formation. METHODS: We harvested 22 deep flexor tendons from adult pig forelimbs and randomly allocated them into 2 groups. After cutting the tendons at a standard point, we performed a 4-strand cross-locked cruciate repair using 3-0 braided polyester with either 2-mm cross-locks (n = 11) or 4-mm cross-locks (n = 11). All repairs were completed with a simple running peripheral suture using 6-0 polypropylene. Repaired tendons were loaded to failure and the mechanism of failure, load to failure, stiffness, and load to 2-mm gap formation were determined. RESULTS: All repairs failed by suture breakage; we noted no suture pullout. There was no difference in load to failure (71.7-71.1 N; p = .89) or stiffness (4.1-4.6 N/mm; p = .23) between the 2-mm cross-lock and the 4-mm cross-lock groups. There was a trend toward higher resistance to 2-mm gap formation with the 4-mm cross-locks (55-62.2 N; p = .07). CONCLUSIONS: Four-strand cross-locked cruciate repairs with cross-lock sizes of 2 and 4 mm provide high tensile strength and are resistant to pullout. Repairs with 4-mm cross-locks tend to provide a more central load distribution and better gapping resistance than repairs with 2-mm cross-locks.

The relationship between gap formation and grip-to-grip displacement during cyclic testing of repaired flexor tendons.

The assessment of repair site gap formation during cyclic loading of reconstructed flexor tendons provides important data on the performance of repair techniques in the early postoperative period. This study describes our cyclic testing protocol and evaluates the relationship between changes in optical gap and grip-to-grip displacement. Sixteen sheep hind limb deep flexor tendons were randomized into four repair groups (n=4 per group): a 2-strand repair (modified Kessler) and 4-strand repair (Adelaide), both with and without a simple running peripheral suture. Repaired tendons were cycled for 1000 cycles at appropriate rehabilitation loads for the reconstruction. Tendons were paused at 18 pre-determined cycle points to measure gap and displacement. A strong positively linear relationship between gap and displacement was demonstrated for all repair groups (R²>0.90). An initial non-linear region during the first 10 cycles was noted with some combined core and peripheral repairs. Although trends in displacement after 10 cycles can be used to reflect gapping behaviour, direct optical measurement of gap remains preferable. We hypothesized that the adjustment of suture strands and equilibration of forces within the reconstruction occurs mostly during the initial 10 cycles. Gap-cycle curves provide a good illustration of dynamic changes at the repair site, and should be added more frequently to cyclic testing studies.

A biomechanical assessment of repair versus nonrepair of sheep flexor tendons lacerated to 75 percent.

PURPOSE: The benefit of repairing a 75% partial flexor tendon laceration remains controversial. The purpose of this study was to assess the degree of gap formation with and without repair when the 75% lacerated tendon is subjected to cyclic loading. Repair with only a peripheral suture was compared to that using a core and peripheral repair technique. METHODS: Sixteen deep flexor tendons from sheep hind limbs were lacerated to 75% of the tendon diameter. The cut tendons were loaded for 100 cycles from 3 N up to 30 N and then back to 3 N, at a rate of 0.2 Hz. Gap formation was measured at 0 and 100 cycles. Tendons were then randomized into 2 repair groups of 8 each: group 1 was repaired with only a simple, running peripheral suture (6-0 polypropylene monofilament), whereas group 2 was repaired with a modified Kessler core suture (4-0 silicone-coated braided polyester) plus a peripheral suture (6-0 polypropylene monofilament). Repaired tendons were tested for 500 cycles, and the gap was measured at 0, 100, and 500 cycles. After cycling, gap was measured at 100 N load, and the peak loads were determined on static failure testing. RESULTS: The 75% partially lacerated tendons had >2 mm gap at 100 cycles. This gap was significantly reduced by peripheral or peripheral plus core repairs (p < .001). There was no difference in gap formation between tendons with peripheral repair only and those with both peripheral and core repairs. Gap formation in repaired tendons remained