Soft Tissue Reinforcement Research Articles

Implantable Biologics for Soft Tissue Surgery Reinforcement.

Soft tissue reinforcement focuses on medical grafts that are designed to support and regenerate soft tissue under or near suture lines. Soft tissue is defined as areas of similarly specialized cells that function to connect, support, and surround other structures and organs of the body. These tissues include skin, subcutaneous tissue, fascia, ligaments, tendons, fibrous tissues, fat, synovial membranes, and muscle. Most of the implantable devices used for this purpose are made of collagen, the most abundant protein in mammals and a key component of the extracellular matrix of soft tissues that allows for tissue repair. For suture line reinforcement, exogenous collagen from various sources is implanted under or in continuity with the suture line to allow for increased strength and better healing. First introduced in the field of breast reconstruction, this practice is now also used in hernia repair, dural repair, vaginal slings, amputation reinforcement, tendon repair reinforcement, and even dental soft tissue regeneration.

Is a soft tissue reinforcing mesh necessary in immediate prosthetic breast reconstruction for early breast cancer in patients with low-volume breast? A single-center, retrospective Chinese clinical study.

It is controversial as to whether soft tissue reinforcement mesh should be used for immediate prosthetic breast reconstruction after nipple-sparing mastectomy for low-volume breast early breast cancer (LVBEBC) in Chinese adult women. We collected data on 89 patients with LVBEBC who underwent such a surgery and divided them into two groups: 39 patients in the totally subpectoral prosthesis-only breast reconstruction group (simple group) and 50 patients in the prosthesis-combined titanium-coated polypropylene mesh (TCPM) group (or the so-called "dual plane" or "mesh-assisted partially subpectoral breast reconstruction group") (combined group). The results demonstrated no difference in operative time, intraoperative bleeding, and postoperative complications between the two groups; however, total drainage volume and extubation time were less and shorter, respectively, in the combined group. The median follow-up time was 18.6months without local recurrence or distant metastasis in both groups. At 24months after surgery, the excellent and good rates of breast reconstruction were higher in the combined group. However, patients' BMI, breast morphology, and breast volume of 300mL or more had an effect on the shape of the reconstructed breast; in addition, in patients with higher BMI, conical breast morphology, and breast volume over 300mL, the shape of the breast was more perfect with the prosthesis combined with TCPM reconstruction.Trial registration: This retrospective study was "retrospectively registered" in the Sixth Affiliated Hospital of South China University of Technology of China on March 15, 2022 (No. 2022018) and in the National Medical Research Registry filing system of China ( https://www.medicalresearch.org.cn ) (No. MR-44-22-003618).

A Unique Approach to Neurosurgical Wound Closure With Porcine Urinary Bladder Matrix: An Illustrative Case Series

Introduction. PUBM is a non-synthetic, completely resorbable xenograft product with a myriad of uses, including management of burns, acute and chronic wounds, soft tissue reinforcement, and hernia repair. The material is available in both powder and sheet forms which allows for excellent coverage of irregularly shaped wounds. Case Report. The authors present 2 challenging neurosurgical wound cases. The first case is a large thoracolumbar wound secondary to a laminectomy complicated by a high output CSF fistula and dermal dehiscence. The second case is a deep postoperative surgical site infection in the setting of a large amount of surgical hardware. Both cases were successfully managed to complete wound healing with PUBM. Conclusion. Neurosurgical wounds can be technically challenging and difficult to manage. CSF fistulas lack evidence for standard treatment strategy, making complications and chronic wounds more likely. The application of PUBM in the closure of neurosurgical wounds has not been thoroughly studied and may lead to improved wound closure.

Evaluation of Xenograft Efficacy in Immediate Prosthesis-based Breast Reconstruction

INTRODUCTION: The advent of acellular dermal matrix (ADM) has revolutionized prosthesis-based breast reconstruction, conferring soft tissue reinforcement to the mastectomy skin flap. However, paucity of human cadaveric tissue has resulted in limitation of supply and increased associated costs, prompting concerted effort to identify alternatives to human ADM, such as xenograft surgical adjuncts, to minimize cost burden to the patient and institution, while maintaining adequate soft tissue support. Although various studies have examined the safety of Artia, a porcine-derived ADM, in prosthesis-based breast reconstruction, few studies have evaluated its clinical efficacy as soft tissue reinforcement. This study uniquely compares clinical efficacy of Artia with AlloDerm, a commonly used human-derived ADM, by examining objective parameters of initial tissue expander (TE) fill volume at the time of mastectomy, number of TE fills, and time interval between exchange of TE for final implant. METHODS: IRB approved retrospective chart review was conducted to identify 273 consecutive TE-based procedures performed at a tertiary academic medical center between March 2017 and March 2021. Of these, 89 cases utilized Artia and 184 utilized AlloDerm. Univariate and binomial logistic regression analyses were conducted to compare patient characteristics and clinical endpoints between Artia and AlloDerm groups. RESULTS: Patients who underwent Artia-based breast reconstruction achieved comparable initial TE fill volume relative to those who underwent AlloDerm-based breast reconstruction (335 ± 198 mL versus 289 ± 158 mL, p = 0.10) and similar time interval to TE-implant exchange (232 ± 124 days versus 242 ± 131 days, p = 0.70) via univariate analysis. However, patients who underwent Artia-based reconstruction experienced fewer number of tissue expansions (3.92 ± 2.97 fills versus 4.99 ± 2.98 fills, p < 0.01). When normalizing for final implant size, which serves as a surrogate for body composition, the Artia group exhibited significantly higher perioperative fill (0.65 ± 0.34 v. 0.49 ± 0.19, p < 0.01). Rates of explantation were higher in the AlloDerm group; however, when controlling for confounding variables, no statistical significance was observed following binomial regression analysis. Otherwise, rates of post-operative complication were similar among groups. CONCLUSION: This study demonstrates efficacy of Artia as an alternative to human-derived ADM in immediate TE-based breast reconstruction. Demonstration of clinical efficacy of non-human cadaveric surgical adjuncts is of paramount importance to facilitate widespread acceptance of these materials and further decrease healthcare costs. This work, therefore, serves as a framework for future studies evaluating xenograft efficacy in breast reconstruction and can guide development of emerging biomaterials and techniques.

OC-035 TEST METHODS FOR SURGICAL MESHES - AN INDUSTRY POINT OF VIEW

Abstract Aim No standardized test methods currently exist for the characterization of the synthetic surgical meshes used in hernia repair and soft tissue reinforcement. While each mesh manufacturer developed their own test methods for comparative analysis, these were never harmonized across industry. A subgroup of the European Association of the Surgical Suture Industry (EASSI) was constituted, the Standardization of Surgical Meshes Working Group (SSM WG) with the objective to reach alignment of surgical meshes test methods. Materials &amp; Methods The SSM WG agreed on the test methods that should be defined to provide a thorough in-vitro-characterization and comparison of surgical meshes. After several interlaboratory iterations, the group established common test protocols which may be performed by people with limited textile background. Extensive inter-laboratory test method verifications were then performed by conducting tests with different specimens by all manufacturers in a consistent manner. Results Common protocols were defined for the following test methods: Linear Tensile Test (Strength and elongation), Burst Test (Strength and displacement), Suture Pull-Out Test (Strength), Pore Size Measurement (Porosity and pore dimensions). 4 meshes were tested by each of the 4 involved manufacturers to assess the protocols validity. Despite methods harmonization, differences could be observed between laboratories. Conclusion The SSM WG recommends following the test protocols described and to maximize the sample size. Due to high sensitivity of specimen and difference in equipment used, only results of tests performed by a single testing center using identical testing features for all tested meshes should be compared.

Evaluation of Xenograft Efficacy in Immediate Prosthesis-based Breast Reconstruction.

Background:The advent of acellular dermal matrix (ADM) has revolutionized prosthesis-based breast reconstruction. However, paucity of human cadaveric tissue has resulted in limitation of supply and increased associated costs, prompting concerted effort to identify xenograft alternatives. Although studies have examined the safety of Artia, a porcine-derived ADM, few have evaluated its clinical efficacy as soft tissue reinforcement. This study uniquely evaluates the clinical efficacy of Artia in implant-based breast reconstruction.Methods:IRB-approved retrospective chart review was conducted to identify 243 consecutive TE-based procedures performed at a tertiary academic medical center between March 2017 and March 2021. Propensity matching was conducted to minimize differences between cohorts. Efficacy metrics, defined as initial tissue expander (TE) fill volume, number of TE fills, and time interval between exchange of TE for final implant, were compared between xenograft (Artia) and allograft (AlloDerm) groups.Results:Patients who underwent Artia-based breast reconstruction achieved superior initial TE fill volume relative to those who underwent AlloDerm-based breast reconstruction via univariate analysis (317.3 ± 185.8 mL versus 286.1 ± 140.4 mL, P < 0.01) when patient and operative characteristics were well-matched. However, linear regression analysis failed to demonstrate difference in efficacy metrics, such as initial TE fill volume (P = 0.31), ratio between initial TE fill volume and final implant size (P = 0.19), and number of TE fills (P = 0.76). Complication rates were comparable between groups.Conclusion:This study suggests that Artia can be used as a safe and efficacious alternative to human-derived ADM in immediate TE-based breast reconstruction.

792 Complete wound healing utilizing procine urinary bladder matrix in a serise of traumatic wounds with significant soft tissue loss

PUBM is a non-synthetic, completely resorbable xenograft product with a myriad of uses including management of burns, acute and chronic wounds, soft tissue reinforcement, and hernia repair. The material is available in both powder and sheet form allowing for excellent coverage of irregularly shaped wounds. We present three patients with significant soft tissue loss that underwent xenograft implantation utilizing PUBM. Despite challenging locations and severity of wounds, 100% healing and wound closure with excellent cosmetic results was achieved.

Commentary on: Bioabsorbable Polydioxanone Mesh for Soft Tissue Reinforcement in Revisional Breast Surgery.

Commentary on: Bioabsorbable Polydioxanone Mesh for Soft Tissue Reinforcement in Revisional Breast Surgery.

Resorbable Synthetic Ventral Hernia Repair in Contaminated Fields: Outcomes with Poly-4-Hydroxybutyrate Mesh.

Hernia repair in the setting of contamination poses unique challenges, including complications such as recurrence and mesh infection. The ideal contaminated hernia repair including type of mesh use remains controversial. Poly-4-hydroxybutyrate is a biosynthetic scaffold for soft-tissue reinforcement and hernia repair and is potentially useful in contaminated hernia repair. The authors aim to describe postoperative outcomes, recurrence, and patient-reported outcomes after contaminated hernia repair with poly-4-hydroxybutyrate. Adult patients (≥18 years) undergoing a contaminated hernia repair with poly-4-hydroxybutyrate (Phasix) performed by a single plastic surgeon between January of 2015 and May of 2020 were identified. Patients with a ventral hernia defect and a Centers for Disease Control and Prevention wound class of II, III, or IV were included. Primary outcomes included recurrence, surgical-site infection, surgical-site occurrences, and surgical-site infection/occurrences requiring procedural interventions. As a secondary outcome, the authors assessed patient-reported outcomes as defined by the Abdominal Hernia-Q and Hernia-Related Quality of Life Survey. Sixty patients were included with a median age of 52.5 and body mass index of 31 kg/m2. Median defect size was 300 cm2. Twenty-eight patients (46.7 percent) experienced a complication. The most common complications were surgical-site occurrence [n = 20 (33.3 percent)] and surgical-site infection [n = 10 (16.7 percent)]. Median follow-up was 24.2 months, with a recurrence rate of 8.3 percent (n = 4). Overall patient-reported outcomes improved postoperatively, and improvement was not affected by the presence of a complication. Poly-4-hydroxybutyrate use in contaminated hernia repair shows promising results with an acceptable safety profile. Although complications are frequent in this complex cohort, patient-reported outcomes improvement was significant even in patients with complications. Therapeutic, IV.

6: Creating Tissue Engineered Nipples Using 3d-printed Poly-4-hydroxybutyrate (p4hb) Bioabsorbable Scaffolds Augmented With Autologous Processed Costal Cartilage

Purpose:Nipple reconstruction is a vital part of breast reconstruction after total mastectomy. However, nearly all autologous tissue techniques utilized for reconstruction of the nipple are hindered by scar contracture and loss of projection of the neo-nipple. Unfortunately, engineered tissue substitutes, such as Cook Biodesign® nipple reconstruction cylinders, have demonstrated suboptimal projection maintenance over time. Costal cartilage (CC) has been described in nipple reconstruction to maintain projection, yet has not been adopted due to the excessively firm nipple that results. Herein we propose using 3D-printed bioabsorbable P4HB (3D-P4HB) scaffolds loaded with processed CC in order to foster ingrowth of tissue that mimics the biomechanical properties of native nipples and to protect the regenerated tissue from contracture as it matures.Methods:3D-P4HB scaffolds (diameter: 1.0cm, height: 1.0cm) were fabricated and sterilized. Patient-derived CC (discarded from DIEP procedures) was either minced (1mm3) or zested (<0.2mm3) in sterile fashion. Processed cartilage-filled 3D-P4HB scaffolds were subcutaneously implanted into nude rats using a CV flap technique. Additional groups consisted of empty 3D-P4HB scaffolds, 3D-P4HB scaffolds with an internal 3D latticework of P4HB filaments (rebar), and non-scaffolded (naked) cartilage. The constructs were explanted at 1, 3 and 6 months, and evaluated by gross, microstructural, histological, and biomechanical analysis.Results:All 3D-P4HB nipple reconstructions were well preserved in diameter and projection at 1, 3 and 6 months, primarily due to the persistence of the scaffold architecture throughout these time points. When compared to the non-scaffolded (naked) group, 3D-P4HB groups demonstrated significantly greater projection at 3 and 6 months (p<0.05). There were no significant differences observed in tissue volume retention between the two processed cartilage-filled 3D-P4HB groups at 1, 3 and 6 months. However, the non-scaffolded (naked) group lost a significant amount of volume in the first 3 months (38% in minced and 26% in zested, p<0.05), but remained unchanged between 3 and 6 months. Newly formed spongy fibrovascular cartilaginous tissue (with viable chondrocytes within the lacunae) was also noted in processed cartilage-filled 3D-P4HB groups. Interestingly, 3D-P4HB (rebar) scaffolds demonstrated the fastest material absorption overtime, as demonstrated by biomechanical testing and SEM analysis which verified widespread pitting on the material surface. Elastic modulus testing indicated minimal change in 3D-P4HB (rebar) scaffold stiffness at 1 month, yet a sharp decrease from 8MPa to 4MPa between 1 to 3 months. Both processed cartilage-filled 3D-P4HB scaffolds slightly increased in stiffness over 6 months within the range of 2 to 3MPa (p>0.05).Conclusion:Using 3D-P4HB scaffolds filled with autologous processed CC, we have engineered nipples that maintain their projection and volume over time, while simultaneously allowing for the maturation of an internal structure of fibrovascular cartilaginous tissue that biomechanically mimics that of native nipples. As the 3D-P4HB scaffold gradually absorbs, data suggest that newly-regenerated tissue may resist scar contracture and maintain projection over time. Because P4HB devices for soft tissue reinforcement have previously been cleared by the FDA and possess a long track record of safety, we believe that this novel 3D-P4HB nipple reconstruction scaffold may be readily translatable to the clinic.

In vivo soft tissue reinforcement with bacterial nanocellulose.

The use of surgical meshes to reinforce damaged internal soft tissues has been instrumental for successful hernia surgery; a highly prevalent condition affecting yearly more than 20 million patients worldwide. Intraperitoneal adhesions between meshes and viscera are one of the most threatening complications, often implying reoperation or side effects such as chronic pain and bowel perforation. Despite recent advances in the optimization of mesh porous structure, incorporation of anti-adherent coatings or new approaches in the mesh fixation systems, clinicians and manufacturers are still pursuing an optimal material to improve the clinical outcomes at a cost-effective ratio. Here, bacterial nanocellulose (BNC), a bio-based polymer, is evaluated as a soft tissue reinforcement material regarding mechanical properties and in vivo anti-adhesive performance. A double-layer BNC laminate proved sufficient to meet the standards of mechanical resistance for abdominal hernia reinforcement meshes. BNC-polypropylene (BNC-PP) composites incorporating a commercial mesh have also been prepared. The in vivo study of implanted BNC patches in a rabbit model demonstrated excellent anti-adherent characteristics of this natural nanofibrous polymer 21-days after implantation and the animals were asymptomatic after the surgery. BNC emerges as a novel and versatile hernioplasty biomaterial with outstanding mechanical and anti-adherent characteristics.

Poly-4-hydroxybutyrate (Phasix™) mesh onlay in complex abdominal wall repair.

Poly-4-hydroxybutyric acid (P4HB, Phasix™) is a biosynthetic polymer that degrades by hydrolysis that can be woven into a mesh for use in soft tissue reinforcement. Herein, we describe our initial experience performing complex abdominal wall repair (CAWR) utilizing component separation and P4HB mesh as onlay reinforcement. All patients undergoing CAWR between June 2014 and May 2017 were followed prospectively for postoperative outcomes. Only those patients who underwent components separation with primary repair of the fascial edges followed by onlay of P4HB mesh were included in this study. 105 patients (52 male, 53 female; mean age 59.2years, range 22-84) met inclusion criteria. Mean BMI was 29.1 (range 16-48); 52% patients had prior attempted hernia repair, most with multiple medical comorbidities (71% of patients with ASA 3 or greater). 30% of cases were not clean at the time of repair (CDC class 2 or greater). Median follow-up was 36months (range 9-63). Eighteen patients (17%) developed a hernia recurrence ranging from 2 to 36months postoperatively. Five (5%) patients developed a localized superficial infection treated with antibiotics, three (2.8%) required re-operation for non-healing wounds, and six (6%) patients developed seroma. These data demonstrate a relatively low rate of hernia recurrence, seroma, and other common complications of CAWR in a highly morbid patient population. Importantly, the rate of mesh infection was low and no patients required complete mesh removal, even when placed into a contaminated or infected surgical field.

Clinically available reinforcing materials for soft tissue reconstruction.

Navigating the rapidly evolving field of materials for soft tissue reinforcement is challenging given the volume of clinically available options. Additionally, the current generally accepted classifications of these mesh materials confound the understanding of their utility by grouping disparate materials that have attributes overlapping category boundaries and that do not fully consider their clinically functionality. This review article highlights, from a materials science perspective, the most important attributes of these materials to improve the clinical decision-making process in the selection of the most appropriate features and design for the patient, surgery and clinical need. These characteristics include the physical attributes that directly impact the surgical procedure and immediate postoperative mechanical requirements as well as the post-implantation properties such as an adequate reinforcement time, strength of the resulting tissue and infection risk profile.

3D Printing of Drug-Loaded Thermoplastic Polyurethane Meshes: A Potential Material for Soft Tissue Reinforcement in Vaginal Surgery.

Current strategies to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI), include the surgical implantation of vaginal meshes. Recently, there have been multiple reports of issues generated by these meshes conventionally made of poly(propylene). This material is not the ideal candidate, due to its mechanical properties leading to complications such as chronic pain and infection. In the present manuscript, we propose the use of an alternative material, thermoplastic polyurethane (TPU), loaded with an antibiotic in combination with fused deposition modelling (FDM) to prepare safer vaginal meshes. For this purpose, TPU filaments containing levofloxacin (LFX) in various concentrations (e.g., 0.25%, 0.5%, and 1%) were produced by extrusion. These filaments were used to 3D print vaginal meshes. The printed meshes were fully characterized through different tests/analyses such as fracture force studies, attenuated total reflection-Fourier transform infrared, thermal analysis, scanning electron microscopy, X-ray microcomputed tomography (μCT), release studies and microbiology testing. The results showed that LFX was uniformly distributed within the TPU matrix, regardless the concentration loaded. The mechanical properties showed that poly(propylene) (PP) is a tougher material with a lower elasticity than TPU, which seemed to be a more suitable material due to its elasticity. In addition, the printed meshes showed a significant bacteriostatic activity on both Staphylococcus aureus and Escherichia coli cultures, minimising the risk of infection after implanting them. Therefore, the incorporation of LFX to the TPU matrix can be used to prepare anti-infective vaginal meshes with enhanced mechanical properties compared with current PP vaginal meshes.

Abstract 83: Minimizing Implant Infection and Capsular Contracture Through the Use of Antibiotic-Eluting Nanofiber Coatings

PURPOSE: Bacterial contamination following implant-based soft tissue reconstruction contributes to significant healthcare costs and patient morbidity. In addition to acute infection, subclinical bacterial colonization is thought to contribute to long-term capsular contracture. The purpose of this study was to design an antibiotic-eluting nanofiber-hydrogel composite sheet for use in implant soft tissue pocket reinforcement. A murine implant infection model was developed to test the impact of the device on implant infection and infection-associated capsule formation. METHODS: Polycaprolactone (PCL) impregnated with linezolid and rifampicin was electrospun into a random-pattern sheet and suspended within a nanofiber-hydrogel composite. Interfacial bonding between the nanofibers and hydrogel matrix was used to improve structural integrity of the material. Mechanical properties and antibiotic release kinetics were assessed in vitro. Silicone disk implants were incubated with a bioluminescent Staphylococcus aureus strain for 24 hours. Biofilm formation was confirmed via crystal violet staining. Thirty-five mice were implanted with either the infected implant alone, infected implant with overlying composite sheet, or infected implant with overlying antibiotic-eluting composite sheet. Bioluminescence imaging was used to assess the in vivo bacterial burden between postoperative days 0 and 15. Postmortem bacterial colony forming unit (CFU) quantification, histology, and immunohistochemistry were performed on harvested tissues. RESULTS: A 1mm-thick nanofiber-hydrogel composite sheet embedded with linezolid and rifampicin was designed and demonstrated favorable mechanical properties, suturability, and antibiotic release kinetics. Use of the antibiotic-eluting composite sheet device resulted in complete prevention of clinical signs of cellulitis and implant exposure. In vivo bacterial luminescence was reduced in the presence of the antibiotic-eluting composite sheet overlay, returning to background signal levels within the study period. The post-mortem bacterial burden within the peri-implant soft tissue was reduced 600-fold (1.8e2 +/- 1.8e2 versus 1.1e5 +/- 1.5e5, p=0.03), as was average capsule thickness (79 +/- 35 μm versus 274 +/- 194 μm, p=0.001) and relative collagen density within the peri-implant space (31.2 +/- 14.2 % versus 44.5 +/- 15.6 %, p=0.02). CONCLUSION: An antibiotic-eluting nanofiber-hydrogel composite device was designed to reduce the risk of infection and capsule formation following implant-based soft tissue reconstruction. The device inhibited in vivo bacterial growth following implantation of a contaminated implant in a mouse model. Placement of the antibiotic-eluting sheet overlay led to a reduction in soft tissue cellulitis, implant exposure, and peri-implant capsule formation. The technique permits tailoring of mechanical properties and antibiotic release kinetics of the device to suit a variety of surgical applications. The device provides a platform for local delivery of medication into the peri-implant space combined with soft tissue reinforcement.

Impact of Acellular Dermal Matrix on Postsurgical Wound Fluid Biomarkers in Prosthetic Breast Reconstruction.

Despite the widespread practice of using biologic scaffolds for soft tissue reinforcement over prosthetic implants, the impact of acellular dermal matrix (ADM) on surgical wound fluid biomarkers over the initial postoperative period after prosthetic breast reconstruction remains poorly understood. Patients undergoing prosthetic breast reconstruction surgery where ADM was likely to be used were consented to have fluid samples collected from surgical drains after surgery. Sample collections occurred at an "Early" time point at 24 to 48 hours after surgery and then a "Late" time point approximately 1 to 2 weeks after surgery. All procedures were performed by a single surgeon. Acellular dermal matrix was placed when prosthetic coverage with autologous tissue could not be achieved. Laboratory analyses were performed in blinded fashion without the knowledge of whether the samples came from the ADM "Present" or "Not Present" group. Twenty-one patients were in the ADM Present group and 18 patients were in the Not Present group. Both groups showed similar demographics based on age and body mass index. Analyses for cell concentration, protein concentration, extracellular matrix protein levels, cell proliferation activity, and matrix metalloproteinase activity showed no significant differences between wound fluid samples from the 2 groups. The presence of ADM does not appear to significantly impact wound biomarkers in prosthetic breast reconstruction. The current study provides useful data regarding the impact of ADM on surgical wound fluid during the initial postoperative period, laying important groundwork for more extensive future studies on the impact of biologic scaffolds on wound biology.

Repair of Massive and Irreparable Rotator Cuff Tear Using Arthroscopic Method.

Rotator cuff tear stands as one of the major origins of shoulder discomfort and disability, especially in elderly patients over 60 years. Improvement of performance and reduction of pain hardly occur in patients with contracted rotator cuff tear. Despite therapeutic advances, yet there are many discussions over choosing the best type of treatment for major rotator cuff tear. Complete care of massive rotator cuff tear continues to be a challenge in shoulder surgery. Treatment options have changed in comparison with traditional treatment methods in open or arthroscopic debridement surgery with or without decompression. Recently, many treatments have been introduced, including a range of non-surgical treatments, acromioplasty by debridement, minor repair biceps tenotomy, tuberoplasty by biceps tenotomy, minor repair, mini-open rotator cuff repair, arthroscopic rotator cuff, muscle movement, reverse shoulder arthroscopy, soft tissue reinforcement and hemiarthroplasty. Non-surgical massive rotator cuff control is typically assigned for patients with insignificant pain. This therapy functions by changing activities, proper use of steroid injections and physical therapy with an emphasis on the anterior deltoid exercises. But the main problem is the selection of the best treatment and making the final decision. In general, in the arthroscopic, morbidity, postoperative pain along with hospital stay are less and the operation has better cosmetic results. So this information and our results have prompted us to study a variety of rotator cuff treatment methods with a focus on the arthroscopic treatment.

The Use of Poly-4-Hydroxybutyrate (P4HB) Scaffold in the Ptotic Breast: A Multicenter Clinical Study.

Mastopexy and reduction mammaplasty are often limited by the patient's poor native soft tissue quality, resulting in ptosis recurrence and loss of rejuvenated surgical results. Surgical scaffolds and acellular dermal matrices are used in these procedures to provide physical and mechanical stabilization of weakened or compromised tissue. GalaFLEX scaffold, made from poly-4-hydroxybutyrate (P4HB), is a next-generation product for soft tissue reinforcement that resorbs gradually while aiding tissue regeneration to achieve excellent outcomes. To assess the clinical performance of GalaFLEX scaffold in soft tissue reinforcement during elective mastopexy and reduction mammaplasty. This multicenter, single-arm, observational study assessed product performance and outcomes of GalaFLEX scaffold when used in breast surgery. Outcomes included ptosis correction and maintenance, associated adverse events, patient and surgeon satisfaction, and mammographic and ultrasound imaging evaluation. At 6 centers in the US, 62 of 69 enrolled patients were treated. Of this population, 89.7% had successful ptosis correction and maintenance at 1 year, with high patient and surgeon satisfaction for breast shape, droop/sag of the breast, and maintenance of results at 1 year. There were 5 adverse events deemed related to the device (8.0%), including nerve pain, breast swelling, ptosis, and 2 instances of asymmetry. GalaFLEX scaffold safely and successfully supports and elevates breast tissue in mastopexy and reduction mammaplasty, with maintained support at 1 year. Surgeon and patient satisfaction were high. No mammogram or ultrasound interference was detected.

Soft tissue reinforcement with a Leeds-Keio artificial ligament in revision surgery for dislocated total hip arthroplasty.

Since dislocation after total hip arthroplasty (THA) greatly diminishes patient's quality of life, the THA frequently needs revision. However, it is common for the dislocation not to heal even after reconstruction, but rather to become intractable. The 17 patients with dislocated THA, mean age of 71 years (range 51-87 years), who underwent a revision THA together with soft tissue reinforcement with a Leeds-Keio (LK) ligament were enrolled. The purposes of reinforcement with LK ligament were to restrict the internal rotation of the hip joint, and to encourage the formation of fibrous tissue in the posterior acetabular wall to stabilise the femoral head. We determined the success rate of surgical treatment for dislocation, the Harris Hip Score (HHS), a factor of recurrent dislocation. There was no recurrent dislocation in 82% of the cases (14 joints) during the mean postoperative follow-up period of 63.5 months (15-96 months). The HHS was 82 ± 18 points preoperatively and 82 ± 14 points postoperatively. Recurrent dislocation after this surgical procedure occurred in 2 hips with breakage of the LK ligaments, and intracapsular dislocation in 1 hip with loosening of the LK ligament. Although the risk of recurrent dislocation still exists with this procedure, when performed to provide reinforcement with an LK ligament for dislocated THA it may be useful in intractable cases with soft tissue defects around the hip joint.

Lateral Ankle Instability Surgical Treatment

Category: Ankle, Sports Introduction/Purpose: Lateral ankle instability is a common cause of disability in the active population. Although the majority of patients can be treated conservatively, surgical repair of the ligaments, with or without reinforcement, represents an excellent option for refractory cases. Failed primary surgical repair, recurrence of the ankle instability and need for revision surgery can rarely happen and is probably affected by multiple variables. That includes patient’s characteristics such as BMI and comorbidities and surgical aspects such as the use of suture anchors and soft-tissue reinforcement. The purpose of this study was to compare patient’s characteristics and complication rates of primary repair and revision procedures. Methods: We retrospectively reviewed 231 patients (160 Female, 71 Male) who underwent surgical treatment for lateral ankle instability between 2010-2016. Thirty-two were revision cases (14.2%), including 24 females and 8 males, and 199 were primary direct repairs (85.8%). The mean age at the time of the surgery was 39 (19-65)years, and average follow-up was 9 (2-55) months. The procedures were performed by four different surgeons. All cases were reviewed based on age, gender, BMI, procedure type and number of incisions, comorbidities, and complications. Data found was compared between the two groups (primary repair and revision surgery) by T-test. A p-value &lt;0.05 was considered significant. Results: The Brostrom-Gould procedure was used in 69.5% of the primary repairs and 63.6% of the revision cases. The use of suture anchors was also similar in both groups (51%). Repair of the calcaneofibular ligament was performed in 68% of primary repairs and 81.8% of the revisions. We didn’t find significant differences regarding comorbidities between two groups: smoking (23.4% x 27.2%, p-value 0.371); diabetes (6.8% x 6%, p-value 0.951) and body mass index above 30 (28.5% x 24.2%, p-value 0.347). We found significant difference in the complication rate of the procedures, with a higher incidence in the revision group (48.4%) when compared to the primary repair group (24%). That included: sural neuritis (15.1% x 3.4%), superficial peroneal neuritis (12.1% x 4.5%), skin problems (9% x 7.4%). Conclusion: Our study of 231 patients that underwent surgical treatment for lateral ankle instability found significant higher incidence of complications in patients who had revision procedures when compared to primary repair. No differences regarding smoking status, diabetes and BMI were found.