An isolated bioinductive repair vs. sutured repair for full-thickness rotator cuff tears: 2-year results of a double blinded, randomized controlled trial.

BACKGROUND: Partial-thickness rotator cuff tears treated with an isolated bioinductive repair (IBR) in lieu of a completion-and-repair have shown complete healing. This treatment option is afforded by the remaining tendon's structural integrity, which is similar to that present in small/medium full-thickness tears (FTTs) when the rotator cable remains intact. This randomized controlled trial (RCT) investigated whether an IBR for small/medium FTTs resulted in superior healing and patient-reported outcomes (PROs) compared with a sutured repair. METHODS: This prospective, double blinded (patients and outcome assessors), single-center RCT enrolled patients ≥18 years with a small/medium (≤2.5cm) full thickness supraspinatus tear and intact rotator cable. Patients were randomized and blinded to arthroscopic transosseous-equivalent repair (control, n = 30) or IBR (n = 30). The primary outcome was tendon quality on biopsy at 6 months. Secondary outcomes were PROs (American Shoulder and Elbow Surgeons [ASES], Constant-Murley Shoulder [CMS], and pain visual analogue scale scores) and tendon thickness and healing measured via MRI at 6, 12, and 24 months; satisfaction at 12 and 24 months; and time to return to work. RESULTS: Baseline demographic, tear, and surgical characteristics were comparable between the groups (IBR: mean age, 54.2 years, 14 male; control: mean age, 56.4 years, 16 male). Measured via 6 month biopsy, highly organized, parallel bundles of collagen, without inflammation, were present in all IBR patients, whereas poorly organized, non-parallel collagen fibers were present in 24/30 (80%) of control patients (P < .0001), with 28/30 having minimal to mild inflammation. The increase in tendon thickness measured via MRI at 6 months from baseline was greater in the IBR group (2.0 mm) than in the control group (0.8 mm) (P < .0001). All IBR patients had 100% healing on MRI at 12 and 24 months. Compared with the control group, the IBR group had higher ASES and CMS scores at each evaluation, less pain at 6 and 12 months, and greater satisfaction at 12 and 24 months (P < .0003). The IBR group returned to work significantly faster (median 90 days [IQR, 25] vs. median 163.5 days [IQR, 24]; P < .0001) than the control group. CONCLUSION: Compared with a sutured repair, the IBR treatment resulted in superior tendon quality, patient outcomes, satisfaction, and return to work. The IBR enabled a robust healing response evident through MRI and biopsy evaluation, demonstrating superior tendon quality and healing.

A highly bioactive THPC-crosslinked recombinant collagen hydrogel implant for aging skin rejuvenation.

Skin aging, a complex physiological progression marked by collagen degradation, poses substantial challenges in dermatology. Recombinant collagen emerges as a potential option for skin revitalization, yet its application is constrained by difficulties in forming hydrogels. We have for the first time developed a highly bioactive Tetrakis(hydroxymethyl) phosphonium chloride (THPC)-crosslinked recombinant collagen hydrogel implant for aging skin rejuvenation. THPC demonstrated superior crosslinking efficiency compared to traditional agents such as EDC/NHS and BDDE, achieving complete recombinant collagen crosslinking at minimal concentrations and effectively inducing hydrogel formation. THPC's four reactive hydroxymethyl groups facilitate robust crosslinking with triple helical recombinant collagen, producing hydrogels with enhanced mechanical strength, excellent injectability, increased stability, and greater durability. Moreover, the hydrogel exhibited remarkable biocompatibility and bioactivity, significantly promoting the proliferation, adhesion, and migration of human foreskin fibroblast-1. In photoaged mice skin models, the THPC-crosslinked collagen hydrogel implant notably improved dermal density, skin elasticity, and reduced transepidermal water loss, creating a conducive environment for fibroblast activity and healthy collagen regeneration. Additionally, it elevated superoxide dismutase (SOD) activity and displayed substantial anti-calcification properties. The THPC-crosslinked recombinant collagen hydrogel implant presents an innovative methodology in combating skin aging, offering significant promise in dermatology and tissue engineering.

Clinical and Optical Coherence Tomography Evidence of Aqueous Humor Flow from the Suprachoroidal Space to Conjunctival Lymphatics.

A surgical technique was developed to enhance aqueous humor (AH) flow through the non-trabecular outflow pathway by rerouting it from the anterior chamber (AC) to the suprachoroidal space (SCS) without detaching the ciliary body from the scleral spur. Medium- and long-term surgical outcomes were retrospectively analyzed in a case series of 58 glaucoma patients. At 6, 12, and 24 months, the mean IOP decreased from 27.8 ± 8.3 to 14.9 ± 5.0 mmHg, median 15.0 (25th percentile (p25)13.0; 75th percentile (p75) 18.0) and 15.2 ± 3.3 mmHg, and hypotensive medication use reduced from a median (p25; p75) of 3 (2; 3) to 0 (0; 2), 0 (0; 2), and 0 (0; 1.5), respectively. Intra- and postoperative complications were few and manageable. Following surgery, no bleb formation occurred in any of the cases (as confirmed by optical coherence tomography). Conjunctival lymphatic vessels (CLVs) developed in 50% of eyes (29/58). Clinically, they developed directly from sclera and had no connection to the surgical site. Analysis further showed that the development of CLVs and their longer visibility period had poor prognostic value for IOP control. If the fluid flow from the SCS to CLVs was resistance-free, no CLV development was evident. However, if any resistance existed in the flow, the fluid accumulated in lymphatics, resulting in their engorgement. The proposed technique was safe and effective in decreasing IOP in glaucoma patients by enhancing AH flow from the SCS to CLVs via connecting intrascleral microchannels.

Revision Rotator Cuff Repair With Versus Without an Arthroscopically Inserted Onlay Bioinductive Implant in Workers' Compensation Patients.

Background: The addition of onlay biological grafts to augment difficult rotator cuff repairs has shown encouraging results in a case series. Purpose/Hypothesis: The purpose of this study was to determine whether the addition of an onlay bioinductive implant would improve repair integrity, shear wave elastographic appearance of the repaired tendon and patch, and patient-rated and/or surgeon-measured shoulder function when used in workers' compensation patients undergoing revision arthroscopic rotator cuff repair. We hypothesized that the addition of the bioinductive implant would enhance repair integrity and clinical outcomes compared with standard repair. Study Design: Cohort study; Level of evidence, 3. Methods: A post hoc matched-cohort study was conducted on prospectively recruited workers' compensation patients who received a bioinductive implant for revision rotator cuff repair (n = 19). The control group was selected from consecutive workers' compensation revision rotator cuff repair patients before the introduction of bioinductive implants. Then, they were matched for age and tear size (n = 32). Kaplan-Meier curves were generated to compare the primary outcome of repair integrity between groups. The secondary outcomes were to evaluate the elastographic appearance of the tendon and patch in the bioinductive implant group and to compare patient-rated and surgeon-measured shoulder function between groups preoperatively and at 1 week, 6 weeks, 3 months, and 6 months postoperatively. Results: No major complications associated with the bioinductive implants were identified. Six months after the revision rotator cuff repair, the retear rate in the bioinductive implant group was 16% (3/19), compared with 19% (6/32) in the age- and tear size-matched control group (P = .458). At the final follow-up, the retear rate in the bioinductive implant group was 47% (9/19) at a mean of 14 months compared with 38% (12/32) at a mean of 29 months in the control group (P = .489). The shear wave elastographic stiffness of repaired tendons augmented with the bioinductive implant remained unchanged at 6 m/s from 1 week to 6 months postoperatively, which is lower than the stiffness of 10 m/s in healthy tendons. There were no significant differences in patient-rated or surgeon-measured outcomes between groups 6 months postoperatively. Conclusion: There were no differences in repair integrity or clinical outcomes between workers' compensation patients who underwent revision arthroscopic rotator cuff repair with an onlay bioinductive implant compared to those who underwent standard revision rotator cuff repair.

An experimental study of the vascular embolism caused by recombinant type III collagen implants and hyaluronic acid.

BACKGROUND: There are significant differences in the reported incidence of vascular complications that result from the injection of different soft tissue fillers. This study aimed to compare the risk of vascular embolism after recombinant type III collagen implants and hyaluronic acid (HA) injection into arteries. METHODS: Different concentrations of recombinant type III collagen and Restylane were injected into the central ear artery of rabbits, to construct an immediate embolization model. We screened for vascular recanalization and tissue necrosis at 30 min, 1 day, and 7 days after injection, and histopathology examination was processed on Day 7. RESULTS: At 30 min after injection, complete recanalization of the central ear artery was observed in 17 rabbits in the C1 group while none in the HA group. On Day 1 after injection, complete recanalization of the CEA main trunk was observed in all rabbits in the collagen group while 50% in the HA group. There was a significant difference between the C1 group and the HA group in terms of vascular recanalization and skin necrosis. CONCLUSION: Under the present experimental conditions, the risk of causing vascular embolism was much lower with collagen than with Restylane. Different doses of collagen at different injection rates have the same safety profile.

Finite Element Analysis of Different Osseocartilaginous Reconstruction Techniques in Animal Model Knees.

Lesions of the articular cartilage are frequent in all age populations and lead to functional impairment. Multiple surgical techniques have failed to provide an effective method for cartilage repair. The aim of our research was to evaluate the effect of two different compression forces on three types of cartilage repair using finite element analysis (FEA). Initially, an in vivo study was performed on sheep. The in vivo study was prepared as following: Case 0-control group, without cartilage lesion; Case 1-cartilage lesion treated with macro-porous collagen implants; Case 2-cartilage lesion treated with collagen implants impregnated with bone marrow concentrate (BMC); Case 3-cartilage lesion treated with collagen implants impregnated with adipose-derived stem cells (ASC). Using the computed tomography (CT) data, virtual femur-cartilage-tibia joints were created for each Case. The study showed better results in bone changes when using porous collagen implants impregnated with BMC or ASC stem cells for the treatment of osseocartilaginous defects compared with untreated macro-porous implant. After 7 months postoperative, the presence of un-resorbed collagen influences the von Mises stress distribution, total deformation, and displacement on the Z axis. The BMC treatment was superior to ASC cells in bone tissue morphology, resembling the biomechanics of the control group in all FEA simulations.

Bleb-Independent Glaucoma Surgery to Activate the Uveolymphatic Route of Non-Trabecular Aqueous Humor Outflow: Short-Term Clinical and OCT Results.

The deep sclerectomy technique was modified to enhance aqueous humor (AH) outflow via the non-trabecular pathway. A pilot study was carried out to assess its safety and effectiveness. Thirty-eight patients were under observation. After superficial scleral flap (4 × 4 mm), deep scleral layers were divided into three parts by three parallel-to-limbus incisions. Deep sclerectomy without creating a window in the Descemetes' membrane was carried out in the distal part. A collagen implant was placed under the sclera of the remaining two parts with one end in the intrascleral pool. The third proximal part was excised to expose the uvea and implant. A Nd:YAG laser trabeculotomy at the surgery site was made on postoperative days 7-10. Outcome measures were IOP change, use of hypotensive medication(s), complications, and the need for a second surgery. At six months, the mean IOP decreased from 29.1 ± 9.2 mm Hg to 14.0 ± 4.3 mm Hg (p = 1.4 × 10-9); hypotensive medication use reduced from 2.9 ± 0.9 to 0.6 ± 1.0 (p = 1.3 × 10-10); complete success was achieved in 68.4% of cases and partial success was achieved in 31.6% of cases. Intraoperative and postoperative complications were rare and manageable. The OCT of the surgery site revealed the absence of bleb in all cases. Lymphatic vessels with characteristic bicuspid valves in their lumen were detected in conjunctiva near the operation site and over it in 32 patients. IOP decrease in the proposed technique was achieved by activation of the uveolymphatic route of AH outflow.

Gentamicin-Containing Collagen Implant May Reduce Surgical Site Infections After Open Infrainguinal Arterial Revascularization.

BACKGROUND: Deep-space surgical site infections carry significant morbidity and mortality. The evidence for gentamicin-containing collagen implants at reducing surgical site infections in open infrainguinal arterial surgery is limited. This study examined whether gentamicin-containing collagen implants reduces 30-day surgical site infections and their severity following open infrainguinal arterial surgery. METHODS: A retrospective observational cohort study that included all patients undergoing infrainguinal arterial bypass or endarterectomy between November 2015 and March 2019 at a single tertiary vascular unit. Patients with contaminated/infected surgical fields, surgical wounds treated with negative pressure therapy, or the usage of antimicrobial implants and dressings other than Collatamp GⓇ (Aralez Pharmaceuticals, Canada) were excluded. Patients with gentamicin-containing collagen implants placed abutting vasculature were compared against patients without gentamicin-containing collagen implants. Outcomes included the rate of surgical site infections and their severity within 30 days after the operation. RESULTS: In 159 procedures (mean age 67.7 years, 74.8% male, 33.3% diabetic, 16.4% chronic renal failure, 25.2% anticoagulated postoperatively, 32.7% with prosthetic implants), 55 (34.6%) procedures received gentamicin-containing collagen implants. There were significantly more males (85.5% vs. 69.2%; P = 0.025), higher rates of obesity (41.8% vs. 26.0%; P = 0.041), and hyperlipidemia (65.5% vs. 49.0%; P = 0.048) in the gentamicin-containing collagen implant group. In total, 6 (3.8%) procedures developed deep-space surgical site infections (1 with gentamicin-containing collagen implant, 5 without) and 13 (8.2%) had severe surgical site infections that required re-intervention (1 with gentamicin-containing collagen implant, 12 without). On logistic regression analysis, the absence of gentamicin-containing collagen implants statistically significantly increased the odds of overall surgical site infections (OR = 2.50; 95% CI 1.01 - 6.19; P = 0.047). There was no statistically significant difference in the odds of deep-space surgical site infections or the severity and need for reintervention of surgical site infections. CONCLUSIONS: This is the first study that examined the effect of gentamicin-containing collagen implants on the severity of surgical site infections in vascular surgery. Gentamicin-containing collagen implants may reduce the odds of overall surgical site infections. It did not reduce the odds of deep-space surgical site infections or the severity and reintervention rate of surgical site infections following infrainguinal arterial revascularization. Larger studies are required to achieve adequate power to assess for these outcomes.

Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry.

BACKGROUND: Surgical treatment of partial-thickness rotator cuff tears remains challenging and controversial, with several traditional options including debridement with acromioplasty, transtendon or in situ repair, and take-down and repair. A resorbable bioinductive bovine collagen implant has shown promise as an alternative treatment option for partial-thickness tears. PURPOSE: Data from a registry were analyzed to further establish that the implant contributes to improved patient-reported outcome (PRO) scores across a large number of patients treated for partial-thickness rotator cuff tears. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A total of 19 centers in the United States enrolled patients >21 years old with partial-thickness tears of the rotator cuff in a comprehensive prospective multicenter registry. PRO scores were recorded preoperatively and postoperatively at 2 and 6 weeks, 3 and 6 months, and 1 year: American Shoulder and Elbow Surgeons, Single Assessment Numeric Evaluation, Veterans RAND 12-Item Health Survey (physical and mental component scores), and Western Ontario Rotator Cuff scores. Revisions were reported throughout the study. RESULTS: The registry included 272 patients with partial-thickness tears (49 grade 1 tears, 101 grade 2 tears, and 122 grade 3 tears), 241 who underwent isolated bioinductive repair (IBR; collagen implant placed after bursectomy without a traditional rotator cuff repair), and 31 who had take-down and repair with bioinductive augmentation. Patients experienced statistically significant and sustained improvement from baseline for all PRO scores beginning at 3 months. Among patients with grade ≥2 tears, those with take-down and repair had significantly inferior scores at 2 and 6 weeks for most PRO scores as compared with those who underwent IBR, but the difference was no longer significant at 1 year for all but the physical component score of the Veterans RAND 12-Item Health Survey. There were 11 revisions, which occurred at a mean ± SD of 188.7 ± 88.0 days after the index surgery. There were no infections. CONCLUSION: This registry analysis further establishes across a large data set that this resorbable bioinductive bovine collagen implant improves PROs in all grades of partial-thickness tears, whether used as IBR or in conjunction with take-down and repair. IBR may offer improved early clinical outcomes (≤6 weeks) and comparable outcomes at 1 year when compared with a more invasive "take-down and repair" approach.

The Effect of a Triple Combination of Bevacizumab, Sodium Hyaluronate and a Collagen Matrix Implant in a Trabeculectomy Animal Model.

Currently available anti-scarring treatments for glaucoma filtration surgery (GFS) have potentially blinding complications, so there is a need for alternative and safer agents. The effects of the intrableb administration of a new combination of the anti-VEGF bevacizumab, sodium hyaluronate and a collagen matrix implant were investigated in a rabbit model of GFS, with the purpose of modulating inflammation, angiogenesis, fibroblast migration and fibrogenesis in the wound healing process. A comparative-effectiveness study was performed with twenty-four rabbits, randomly assigned to the following treatments: (a) biodegradable collagen matrix implant (Olo), (b) bevacizumab-loaded collagen matrix implant (Olo-BVZ), (c) bevacizumab-loaded collagen matrix implant combined with sodium hyaluronate (Olo-BVZ-H5) and (d) sham-operated animals (control). Rabbits underwent a conventional trabeculectomy and were studied over 30 days in terms of intraocular pressure and bleb characterization (height, area and vascularity in central, peripheral and non-bleb zones). Histologic differences among groups were further evaluated at day 30 (inflammation, total cellularity and degree of fibrosis in the area of surgery). Local delivery of bevacizumab (Olo-BVZ and Olo-BVZ-H5) increased the survival of the filtering bleb by 21% and 31%, respectively, and generated a significant decrease in inflammation and cell infiltration histologically 30 days after surgery, without exhibiting any local toxic effects. Olo-BVZ-H5 showed less lymphocyte infiltration and inflammation than the rest of the treatments. Intraoperative intrableb implantation of bevacizumab, sodium hyaluronate and a collagen matrix may provide an improved trabeculectomy outcome in this model of intense wound healing. This study showed an effective procedure with few surgical complications and a novel combination of active compounds that offer new possibilities to improve the efficacy of filtration surgery.

Isolated bioinductive repair of partial-thickness rotator cuff tears using a resorbable bovine collagen implant: two-year radiologic and clinical outcomes from a prospective multicenter study.

BACKGROUND: Current surgical treatment options for partial-thickness tears (eg, takedown and repair, in situ repair) are limited by the degenerative nature of the underlying tendon and may require extensive intervention that can alter the anatomic footprint. The complexity of available techniques to address these issues led to the development of a resorbable collagen implant, which can be used to create a bioinductive repair of partial-thickness tears. METHODS: We prospectively enrolled 33 patients with chronic, degenerative, intermediate-grade (n = 12), or high-grade (n = 21) partial-thickness tears (11 articular, 10 bursal, 4 intrasubstance, and 8 hybrid) of the supraspinatus tendon in a multicenter study. After arthroscopic subacromial decompression without a traditional rotator cuff repair, a bioinductive implant was secured over the bursal surface of the tendon. Clinical outcomes were assessed using American Shoulder and Elbow Surgeons (ASES) and Constant-Murley scores (CMS) preoperatively and at 3 months, 1 year, and 2 years postoperatively. Magnetic resonance imaging was performed to assess postoperative tendon healing and thickness at the original tear site. RESULTS: At 2-year follow-up, mean ASES and CMS scores improved both clinically and statistically at 1 and 2 years, compared with baseline, for intermediate- and high-grade tears. There was magnetic resonance imaging evidence of new tissue fill-in within the original baseline tear in 100% of the intermediate-grade tears and 95% of the high-grade tears. In 90.9% of the intermediate-grade tears and 84.2% of the high-grade tears, this new tissue fill-in represented at least an additional 50% of the volume of the initial lesion. From baseline to 2-year follow-up, the mean tendon thickness increased by 1.2 mm (standard deviation, 1.3; P = .012) and 1.8 mm (standard deviation, 2.2; P = .003) in the intermediate- and high-grade tears, respectively. The analysis of tear grade and location revealed no statistically significant difference in the change in mean tendon thickness at any time point. One patient with a high-grade articular lesion demonstrated progression to a full-thickness tear; however, the patient was noncompliant and the injury occurred while shoveling snow 1 month after surgery. Neither tear location nor treatment of bicep pathology affected the ASES or CMS scores at any follow-up point. No serious adverse events related to the implant were reported. CONCLUSION: Final results from this 2-year prospective study indicate that the use of this resorbable bovine collagen implant for isolated bioinductive repair of intermediate- and high-grade partial-thickness rotator cuff tears of the supraspinatus is safe and effective, regardless of tear grade and location.

Gentamicin Containing Collagen Implants and Groin Wound Infections in Vascular Surgery: A Prospective Randomised Controlled Multicentre Trial.

OBJECTIVE: The aim of this study was to assess the effectiveness of gentamicin containing collagen implants in the reduction of surgical site infections (SSIs) in patients undergoing an inguinal incision for vascular surgery. METHODS: Prospective blinded randomised controlled multicentre trial (RCT), performed in four hospitals in The Netherlands and Belgium. This study included 288 patients who underwent an inguinal incision for primary arterial repair (femoral endarterectomy, femorofemoral or femoropopliteal bypass, aortobifemoral bypass, thrombectomy, embolectomy, endovascular aneurysm repair) between October 2012 and December 2015. Patients were randomised to receive a gentamicin implant (study group) or no implant (control group). The calculated sample sizes of 304 patients per group were not reached. Primary outcome was SSI incidence after six weeks. Secondary outcomes were time to onset of infection, length of hospital stay, allergic reactions, treatment with antibiotics, need for re-admission, re-operation and mortality. RESULTS: One hundred fifty-one patients were allocated to the study group (mean age 69 ± 9.2 years) and 137 patients were allocated to the control group (mean age 70 ± 10.4 years). Both groups were homogeneous regarding baseline and intra-operative characteristics. Gentamicin implants did not result in a significant overall reduction of SSIs in the study group (7% vs. 12%, p = .17). In a post hoc analysis comparing two study sites with low (<10%) and two study sites with high (>10%) infection rates in the control group, gentamicin implants significantly reduced SSIs in high risk centres (22% vs. 1%, p < .001), whereas there was no significant effect in low risk centres (13% vs. 7%, p = .30). There were no allergic reactions and all secondary outcomes were comparable between groups. CONCLUSION: Gentamicin implants did not result in a significant overall reduction of SSIs in this RCT. Gentamicin implants did reduce the incidence of SSIs in high risk centres and may be a valuable adjunct to improve outcomes in such vascular centres with a high incidence of wound infections. However, the limitation of not reaching the calculated sample sizes should be considered.

Effect of filtering bleb dimensions on postoperative intraocular pressure in deep sclerectomy with collagen implant: a comparative study.

INTRODUCTION: The mechanisms of intraocular pressure (IOP) lowering in deep sclerectomy (DS) are multiple. Using collagen implants is one of the proposed mechanisms of DS success. It has been established to work via maintenance of subscleral decompression lake. However, the relation to conjunctival bleb formation is not fully established. METHOD: This study is a retrospective review of the records of 40 eyes of 30 patients with chronic open-angle glaucoma. Patients were divided into two groups; 20 eyes with DS using the Ologen implant (group A), and 20 eyes with DS without implant (group B). The records of UBM that was done for all patients 1 and 6 months after surgery were assessed for the extent, height of conjunctival bleb, depth of AC, the presence of intrascleral bleb and presence of collagen implant. RESULTS: Extent and height of conjunctival bleb by UBM in group A at 1 and 6 months were 3.46 ± 0.77 mm, 1.6 ± 0.38 and 3.71 ± 1.24 mm, 1.6 ± 0.64, respectively. In group B, they were 2.4 ± 1.12 mm, 0.99 ± 0.69 and 2.69 ± 1.77 mm, 0.81 ± 0.67 mm, respectively; the difference was statistically significant. Correlation using Pearson's correlation coefficient test showed significant negative correlation between extension of the bleb at 6 months and 3rd month postoperative IOP (r = - 0.447, P value 0.048) and significant negative correlation of the height at 6 months to 5th month IOP (r = - 0.491, P 0.028). CONCLUSION: Using collagen implant in DS significantly increases conjunctival bleb dimensions, which reflects on lower postoperative IOP.

Cartilage regeneration using decellularized cartilage matrix: Long-term comparison of subcutaneous and intranasal placement in a rabbit model.

Autologous cartilage as donor tissue for various surgical reconstructions such as nasal septum regeneration is limited and associated with donor site morbidity. Our goal was to evaluate a new resorbable chondroconductive biomaterial made of decellularized porcine nasal septum cartilage compared with autologous native auricular cartilage as the gold standard. In order to examine the material and determine its long-term outcome further, we used subcutaneous implantation and septal implantation in an orthotopic rabbit model. In addition to non-seeded decellularized xenogenic cartilage, chondrocyte-seeded decellularized xenogenic cartilage was implanted as a septal replacement. After a three- or six-month period, the formation of newly synthesized cartilage extracellular matrix was evaluated immunohistochemically, whereas septal integrity and biocompatibility were evaluated histologically. The formation of the implanted neoseptum and form stability was analyzed by using 7-Tesla Magnetic Resonance Imaging. Good biocompatibility with no excessive rejection was demonstrated in all groups. Long-term stable and reliable septal reconstruction could be achieved in the study groups with or without cell seeding with autologous auricular chondrocytes. Autologous cell seeding was advantageous only with regard to septal perforations. Thus, cell seeding provides a benefit regarding long-term stability. However, because of slightly better biocompatibility, less pronounced septum deviation and the markedly lower effort involved, the non-seeded scaffold is favoured for possible clinical application.

Trabeculectomy with subconjunctival collagen implant in Indian eyes: Long-term results.

PURPOSE: To report long-term safety and efficacy of trabeculectomy with collagen implant in Indian population. METHODS: All cases of trabeculectomy with Ologen® Collagen Matrix implant performed over a 7-year period from May 2008 through April 2015 at a tertiary referral institute were reviewed. A total of 30 eyes of 28 patients were included in the study with two patients undergoing bilateral trabeculectomy. Outcomes measured included intraocular pressure (IOP) control, number of antiglaucoma medications used, bleb morphology, and complications/reoperations. RESULTS: Trabeculectomy resulted in reduction in IOP from 36.46 to 11.65 mm Hg in the immediate postoperative period (day 1), a 68% decrease to 15.18 mm Hg at 84 months (58% decrease). The mean IOP reduction decreased over time from 63% in the first year to 55% after 5 years of follow-up. Fourteen eyes attained a follow-up of 5 years and eight eyes a follow-up of ≥7 years. No sight-threatening complication such as hypotony, bleb leak, and bleb-related endophthalmitis was observed in our series, and only intervention required was 5-fluorouracil needling in one case. CONCLUSION: Ologen-augmented trabeculectomy is effective in controlling IOP over a long-term follow up from minimal 3 to maximal 7 years. No untoward events jeopardizing bleb safety were noted at any time. This modality is a viable alternative for patients with contraindications to use of antimetabolites.

The gentamicin-collagen implant and the risk of distant metastases of rectal cancer following short-course radiotherapy and curative resection: the long-term outcomes of a randomized study.

PURPOSE: A previous randomized study conducted by our group showed that application of gentamicin-collagen implant (GCI) into the pelvic cavity after total mesorectal excision (TME) reduced the incidence of distant metastases. Therefore, we decided to conduct a confirmatory study. METHODS: Patients with rectal cancer were included in the study if they met the following criteria: adenocarcinoma of the rectum, preoperative short-term radiotherapy (5 × 5 Gy), and WHO performance score 0-1. RESULTS: One hundred seventy-six patients were randomly assigned either to an experimental group in which GCI was applied (n = 81) or to a control group without GCI (n = 81). Median follow-up was 80 months. Cumulative incidence of distant metastases at 5 years was higher in the control group compared to the experimental group: 23.5 vs 8.6% (HR 2.4 [95% CI 1.1-5.5], P = 0.005). Overall survival (OS), disease-free survival (DFS), and cancer-specific survival (CSS) did not differ between the experimental group and the control group: HR 0.95 [95% CI 0.55-1.70], P = 0.864; HR 0.85 [95% CI 0.50-1.45], P = 0.548, and HR 0.5 [95%CI 0.22-1.22], P = 0.093, respectively. The predefined by the protocol subgroup analysis for yp stage III disease showed better DFS in the experimental group compared to the control group; HR 0.47 [95%CI 0.23-0.97], P = 0.042). CONCLUSIONS: The results confirmed our previous finding that GCI applied in the pelvis significantly reduced the rate of distant metastases in patients after radical rectal cancer resection.

Repair of a Giant Omphalocele in an Infant With a Pericardial Implant Crosslinked With Oligourethane.

The giant omphalocele (GO) represents a challenge for the pediatric surgeon in its management and wall abdominoplasty. Here, we report the outcome of a case in which a GO in a newborn patient was repaired with an implant derived from decellularized bovine pericardium crosslinked with oligourethane. The implantation time was extended for 6 months. This was then followed up by the retrieval of the implant and the subsequent reconstruction in a second surgical time by the closure of the abdominal wall fascia. A short hospital stay, early integration into the patient's family environment, as well as early onset of the oral route without special care of the implant or reconstructed wall nor food restrictions were observed. The reduced presence of the complications described in the literature after application of surgical meshes suggests that this implant can be an effective and safe alternative method in the treatment of abdominal wall defects such as GO.

Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: a prospective multicenter study.

BACKGROUND: Treatment of partial-thickness cuff tears remains controversial. Although conservative therapy may treat symptoms, these defects do not spontaneously heal and conversion to a full-thickness lesion with subsequent repair may alter the tendon footprint. The ability to induce new tissue formation and limit tear progression in intermediate- and high-grade partial-thickness tears without surgical repair may represent a significant advancement in the treatment paradigm for these lesions. METHODS: We prospectively enrolled 33 patients with chronic, degenerative, intermediate-grade (n = 12) or high-grade (n = 21) partial-thickness tears (11 articular, 10 bursal, 4 intrasubstance, and 8 hybrid) of the supraspinatus tendon in a multicenter study. Following arthroscopic subacromial decompression without repair, a bioinductive implant was attached over the bursal surface of the tendon. Clinical outcomes were assessed using American Shoulder and Elbow Surgeons and Constant-Murley scores preoperatively and at 3 and 12 months postoperatively. Magnetic resonance imaging was performed to assess postoperative tendon healing and thickness at the original tear site. RESULTS: At 1-year follow-up, clinical scores improved significantly (P <.0001) and the mean tendon thickness increased by 2.0 mm (P <.0001). Magnetic resonance imaging evidence of complete healing was found in 8 patients and a considerable reduction in defect size was shown in 23, whereas 1 lesion remained stable. In 1 noncompliant patient with a high-grade articular lesion, progression to a full-thickness tear occurred while shoveling snow 1 month after surgery. No serious adverse events related to the implant were reported. CONCLUSIONS: Arthroscopic implantation of a bioinductive collagen scaffold is a safe and effective treatment for intermediate- to high-grade partial-thickness rotator cuff tears of the supraspinatus tendon.

Hybrid collagen sponge and stem cells as a new combined scaffold able to induce the re-organization of endothelial cells into clustered networks.

The time needed to obtain functional regenerated bone tissue depends on the existence of a reliable vascular support. Current techniques used in clinic, for example after tooth extraction, do not allow regaining or preserving the same bone volume. Our aim is to develop a cellularized active implant of the third generation, equipped with human mesenchymal stem cells to improve the quality of implant vascularization. We seeded a commercialized collagen implant with human mesenchymal stem cells (hMSCs) and then with human umbilical vein endothelial cells (HUVECs). We analyzed the biocompatibility and the behavior of endothelial cells with this implant. We observed a biocompatibility of the active implant, and a re-organization of endothelial cells into clustered networks. This work shows the possibility to develop an implant of the third generation supporting vascularization, improving the medical care of patients.

Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up.

BACKGROUND: partial-thickness rotator cuff tears frequently enlarge due to increased local strain and often progress to full-thickness tears. Studies suggest the addition of new tendinous tissue to injured cuff tendons would significantly decrease peak strain, possibly protecting against tear progression. The aim of this study was to assess the ability of a highly-porous collagen implant to induce new tissue formation and limit tear progression when placed on the bursal surface of partial-thickness cuff tears. METHODS: following arthroscopic subacromial decompression, the implant was attached to the bursal surface of the supraspinatus tendon in a prospective series of 13 consecutive patients with intermediate - (3-6 mm) to high-grade (>6 mm) partial - thickness cuff tears (5 articular, 3 bursal, 5 intra-substance). Tendon thickness, defect size, and tendon quality were evaluated using magnetic resonance imaging (MRI) preoperatively and at 3, 6, 12, and 24 months postoperatively. Clinical outcomes were assessed using the Constant and American Shoulder and Elbow Society scores at the same preoperative and follow-up times. All 13 patients completed all follow-up exams (mean length of follow-up 27.0 months, range 23.3-32.0); no patients were lost to follow-up. RESULTS: the implant induced significant new tissue formation in all patients by 3 months (mean increase in tendon thickness 2.2 ± 0.26 mm). This tissue matured over time and became radiologically indistinguishable from the underlying tendon. The partial-thickness cuff tears showed consistent filling of the defects, with complete healing in 7 patients at 12 months, and a progressive improvement in tendon quality in the remaining patients. No tear progression was observed by MRI in any of the patients at 24 months. All clinical scores improved significantly over time. At 24 months, 12 of 13 patients (92%) had satisfactory or better results. CONCLUSIONS: the results of this clinical study demonstrated the ability of a highly-porous collagen implant to induce new tendon-like tissue formation and create an environment conductive to the healing of partial-thickness cuff tears.