Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial.

BACKGROUND: Dynamic nasal valve collapse (NVC) is a common factor contributing to nasal obstruction; however, it is often underdiagnosed and untreated. An in-office, minimally invasive procedure addressing dynamic NVC uses a bioabsorbable implant (Latera) to support the lateral nasal wall. This study aimed to evaluate the safety and effectiveness of the treatment in a randomized controlled trial (RCT) with sham control. METHODS: In this prospective, multicenter, single-blinded RCT, 137 patients from 10 clinics were randomized into 2 arms: treatment arm (70 patients) and sham control arm (67 patients). Outcome measures were followed through 3 months after the procedure. The primary endpoint was the responder rate (percentage of patients with reduction in clinical severity by ≥1 category or ≥20% reduction in Nasal Obstruction Symptom Evaluation [NOSE] score). RESULTS: Before the procedure, there were no statistically significant differences in patient demographics and nasal obstruction symptom measures between the 2 arms. Three months after the procedure, responder rate was significantly higher for the treatment arm compared to the control (82.5% vs 54.7%, p = 0.001). Patients in the treatment arm also had a significantly greater decrease in NOSE score (-42.4 ± 23.4 vs -22.7 ± 27.9, p < 0.0001) and significantly lower visual analogue scale (VAS) scores (-39.0 ± 29.7 vs -13.3 ± 30.0, p < 0.0001) than the sham control arm. Seventeen patients reported 19 procedure/implant-related adverse events, all of which resolved with no clinical sequelae. CONCLUSION: Our study shows the safety and effectiveness of the bioabsorbable implant in reducing patients' nasal obstruction symptoms.

Radiographic Tibial Tunnel Assessment After Anterior Cruciate Ligament Reconstruction Using Hamstring Tendon Autografts and Biocomposite Screws: A Prospective Study With 5-Year Follow-Up.

PURPOSE: To radiographically assess the tibial tunnel up to 5 years after anterior cruciate ligament (ACL) reconstruction using hamstring tendon autografts and biocomposite interference screws. METHODS: Fifty-one patients underwent anatomic single-bundle ACL reconstruction with metal interference screws in the femur and biocomposite interference screws in the tibia. Standardized digital radiographs with weight-bearing anteroposterior and lateral views of the index knee were taken in the early postoperative period and at 2 and 5 years postoperatively. Of 51 patients, 40 (78%) underwent radiographic assessment on all 3 occasions. Subjective and objective clinical assessments were obtained preoperatively and at the 5-year follow-up. RESULTS: The mean follow-up period was 65 months (±3.9 months), with a minimum of 59 months. The width of the tibial tunnel on the anteroposterior view was 9.4 mm (±1.4 mm) in the early postoperative period and 9.2 mm (±1.5 mm) at 5 years (P = .64). The corresponding widths on the lateral view were 9.6 mm (±1.5 mm) in the early postoperative period and 9.0 mm (±1.4 mm) at 5 years (P = .014). In 33 of 40 patients (83%) the width of the tibial tunnel had decreased on 1 or both views at 5 years compared with the early postoperative period. The study group had improved significantly at the 5-year follow-up compared with the preoperative assessments in terms of the KT-1000 arthrometer laxity tests (MEDmetric, San Diego, CA), pivot-shift test, Tegner activity scale, and Lysholm knee score (P < .001). No correlations were found between the tunnel widths and the KT-1000 assessment. CONCLUSIONS: In 83% of patients, the width of the tibial tunnel had decreased on 1 or both radiographic views at 5 years compared with the early postoperative period after ACL reconstruction using biocomposite interference screws. LEVEL OF EVIDENCE: Level II, prospective study.

Evaluation of a steroid releasing sinus implant for the treatment of patients undergoing frontal sinus surgery for chronic rhinosinusitis.

INTRODUCTION: Management of the frontal sinus places great demands on the otolaryngologist. Given that the fronto-ethmoidal region is susceptible to recurrent inflammation, scarring, and stenosis, maintaining long-term patency of the frontal sinus is a difficult challenge. Oral and topical anti-inflammatory therapy, post-operative stenting, and 'home-brew' drug elution have been used for the treatment of the frontal sinus with mixed success. Recently an implant has been approved for post-operative placement into the frontal recess. This implant provides reliable and consistent steroid drug elution to address inflammation of the frontal recess secondary to chronic sinusitis. Areas covered: This review discusses the development and application of steroid eluting implants in the postoperative care of patients with chronic frontal sinusitis. All randomized controlled trials evaluating steroid eluting implants are discussed. Relevant supporting material discussing background, economics, safety are included. Expert commentary: Steroid eluting implants fulfill a unique niche in the treatment following frontal sinus surgery. They are shown to decrease the need for post-operative interventions and improve outcomes in patients with chronic sinusitis. There is significant potential for growth in the use of steroid eluting implants.

Differential thrombotic prolapse burden in either bioresorbable vascular scaffolds or metallic stents implanted during acute myocardial infarction: The snowshoe effect: Insights from the maximal footprint analysis.

BACKGROUND: The hypothesized increased thrombus entrapment during bioresorbable vascular scaffold implantation in acute myocardial infarction, the so-called "snowshoe effect" has never been demonstrated. METHODS: Patients enrolled in the BVS STEMI FIRST study matched with STEMI patients implanted with everolimus-eluting metal stents (EES) and undergoing optical coherence tomography (OCT) at the index procedure were compared. Quantitative coronary angiography analysis and optical coherence tomography data for evaluation of thrombotic prolapse were reported. Percentage maximal footprint (%MFP) analysis as an indicator of the snowshoe effect was performed. RESULTS: A total of 302 patients were analyzed (151 with BVS and 151 with EES). Of those patients 30 implanted with BVS and 17 implanted with EES were imaged at the index procedure with OCT. Baseline clinical characteristics, TIMI-flow and thrombus burden were similar between groups. Aspiration thrombectomy was similarly performed in the two groups (BVS 83.3% vs 94.1% EES, p=0.405). At the end of the procedure, final TIMI 3 flow was achieved in 93.3% and 82.4% of BVS and EES patients respectively (p=0.296). The %MFP was significantly higher in the BVS treated patients (36.59±5.65% vs 17.61±4.30, p<0.001). The results of the OCT analysis showed a mean prolapse area (0.61±0.26mm(2) vs 0.90±0.31mm(2), p=0.001) and a percentage prolapse area (7.11±2.98mm(2) vs 9.98±2.90mm(2), p=0.002) significantly higher in the EES group. CONCLUSIONS: Scaffold structural characteristics such as strut width may play a role in terms of thrombus dislodgment patterns and acute prolapsing material.

Ultrasonographical assessment of implanted biodegradable device for long-term slow release of methotrexate into the vitreous.

Our group has developed a biodegradable drug delivery device (micro-implant) for long-term slow intraocular release of methotrexate (MTX) that can be implanted in the peripheral vitreous. The purpose of this study was to assess the position of the implanted devices and the status of the adjacent vitreous and peripheral retina over time using B-scan ocular ultrasonography (US). In each of the eight New Zealand rabbits used in this study, a chitosan (CS) and poly-lactic acid (PLA)-based micro-implant containing approximately 400 µg of MTX and a placebo micro-implant without MTX were inserted into the peripheral vitreous of the right and left eyes, respective, employing minimally invasive surgery. B-scan US imaging was performed on all of the rabbits immediately after implant insertion and on two rabbits at each of several pre-determined time points post-insertion (post-insertion days 5, 12, 19, and 33) to evaluate the position of the micro-implants and identify any evident morphological changes in the micro-implants and in the peripheral retina and vitreous during treatment. US imaging revealed stable positioning of the PLA-coated CS-based MTX micro-implant and the placebo micro-implant in the respective eyes throughout the study and lack of any changes in size, shape or sonoreflectivity of the micro-implants or abnormalities of the peripheral vitreous or retina in any of the study eyes. In summary, US did not show any evident morphological changes in the micro-implants, shifts in post-insertion position of the micro-implants, or identifiable changes in the micro-implants or peripheral vitreous and retina of the study eyes.

Development of a Novel Model for the Assessment of Dead-Space Management in Soft Tissue.

Following extensive surgical debridement in the treatment of infection, a "dead space" can result following surgical closure that can fill with hematoma, an environment conducive to bacterial growth. The eradication of dead space is essential in order to prevent recurrent infection. This study describes a novel small animal model to investigate dead-space management in muscle tissue. Two absorbable test materials were implanted in each animal; beads of calcium sulfate alone, and beads loaded with vancomycin and tobramycin. In-life blood samples and radiographs were taken from each animal following implantation. Animals were sacrificed at 1, 7, 21, 42, and 63 days post-operatively (n = 4), and implant sites were analysed by micro-computed tomography, histology and immunohistochemistry. Complete resorption was confirmed radiographically at 3 weeks post-implantation. Histologically, the host tissue response to both materials was identical, and subsequent healing at the implant sites was observed with no dead space remaining. Vancomycin was not detected in blood serum. However, peak tobramycin levels were detected in all animals at 6 hours post-implantation with no detectable levels in any animals at 72 hours post implantation. Serological inflammatory cytokine expression for IL-6, TNF-α and IL-1ß indicated no unusual inflammatory response to the implanted materials or surgical procedure. The model was found to be convenient and effective for the assessment of implant materials for management of dead space in muscle tissue. The two materials tested were effective in resolving the surgically created dead space, and did not elicit any unexpected adverse host response.

Regulatory Considerations in the Design and Manufacturing of Implantable 3D-Printed Medical Devices.

Three-dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D-printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D-printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D-printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D-printed bioresorbable implantable device.

Beyond biologics: absorbable mesh as a low-cost, low-complication sling for implant-based breast reconstruction.

BACKGROUND: There is an intense push to decrease overall healthcare costs in the United States. Although the use of acellular dermal matrix in implant-based reconstruction has grown significantly over the past decade, potential drawbacks remain a source of debate. Matrices are costly and not universally available across institutions, whereas Vicryl mesh is widely available, relatively inexpensive, and resistant to bacteria biofilm formation. With the intent of maximizing the reconstructive and economic advantages of direct-to-implant breast reconstruction, the authors report the first experience in the literature using an absorbable mesh as an inferolateral sling. METHODS: A retrospective review was performed of the first 50 consecutive patients (76 reconstructions) who underwent implant-based breast reconstruction with Vicryl mesh from August of 2011 until June of 2012. RESULTS: Fifty patients underwent 76 direct-to-implant reconstructions with Vicryl mesh between August of 2011 and June of 2012 (mean follow-up, 1.2 years). Five breasts (6.6 percent) had complications, with only one complication resulting in implant loss (1.3 percent). Implant positioning and contour were excellent, with only two patients [three breasts (3.9 percent)] undergoing revision procedures, for size enlargement. Using costs available at the authors' institution, use of Vicryl mesh instead of acellular dermal matrix resulted in a direct material cost savings of $172,112 in 10 months. CONCLUSIONS: Results to date have been encouraging, with a low complication rate (6.6 percent) and excellent aesthetic results. The technique has resulted in $172,112 in direct material cost savings over 10 months. Continued follow-up is planned to evaluate long-term results. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

[Experimental assessment of biodegradable polyglycolic and polylactic acid polymers for medical use].

Interrelations of biodegradable poliglicolic and polilactic acid polymers in various proportions implanted in standardized bone defects were evaluated in animal model with 40 Wister line rats. During 10 month follow-up period bone capsule surrounded all implants, but timing of bone formation and bone quality varied significantly being optimal in LactoSorb group. Destructive features of polymers were also seen in implant-bone contact area defined as inflammation, fibrous tissue formation and cell dystrophy.

Prospective assessment of complications associated with ultrasound activated resorbable pin osteosynthesis in pediatric craniofacial surgery: preliminary results.

Ultrasound activated resorbable pin osteosynthesis (UARPO) has recently shown favourable results in operations on children suffering for craniosynostosis. However, data on complications coming with this new technique in children suffering from craniosynostoses are scarce and have only been assessed retrospectively so far. It has been the aim of the present study to prospectively follow up children undergoing craniosynostosis surgery with a focus on complications related to UARPO materials. Ten pediatric patients (3 female/7 male) were operated due to craniosynostosis at an average age of 9.1±3.8 months using UARPO (SonicWeld/Resorb-X, KLS Martin, Tuttlingen, Germany). Clinical followup evaluations were carried out 1, 3, 6, 9, 12 and 18 months after surgery according to signs of local infection, stability of the remodeled cranial vault and the palpability of the osteosynthesis material. If secondary surgery was necessary, the indication was documented and evaluated by histological and wound smear examinations. No intra-operative or postoperative complications during the inpatient period occurred. 3 patients needed secondary operation due to a localized chronic swelling at the former incision site which developed 3, 9 and 12 months after the operation. Histological examinations yielded a giant cell formation surrounding the resorbable materials in all cases. Additionally, the wound smear showed a bacterial infection in one site. The current prospective study is the first in the field. It reveals a high percentage of delayed foreign body reactions with UARPO, bearing the need of secondary surgery. It seems that this high complication rate found in the present prospective study may weigh out the advantages of UARPO.

Poly-L/D-lactic acid anchors are associated with reoperation and failure of SLAP repairs.

PURPOSE: This study investigates factors associated with failure and reoperation after glenoid labrum repair. METHODS: We studied a nonconcurrent cohort of consecutive patients undergoing arthroscopic superior labrum repair at a single institution by 2 fellowship-trained surgeons over a 10-year period. RESULTS: There were 348 patients included in this study with a mean age of 33.4 years (95% confidence interval [CI], 32.1 to 35.9) and a mean clinical follow-up of 12.3 months (95% CI, 10.9 to 13.8). The overall reoperation rate was 6.3%, with a revision labrum repair rate of 4.3%. Subsequent surgery and failure after arthroscopic labrum repair were significantly correlated with Workers' Compensation claims (odds ratio [OR], 4.6; P < .001; 95% CI, 1.8 to 11.7), the use of tobacco (OR, 12.0; P = .03; 95% CI, 1.2 to 114.9), and the use of absorbable poly-L/D-lactic acid (PLDLA) anchors (100% correlation, P < .001). The OR for having repeat surgery was 12.7 (95% CI, 4.9 to 32.9; P < .001) with poly-96L/4D-lactic acid (Mini-Revo; Linvatec, Largo, FL) and also increased with the use of poly-70L/30D-lactic acid (Bio-Fastak and Bio-Suturetak; Arthrex, Naples, FL) anchor material (P = .04) after removal of the patients exposed to poly-96L/4D-lactic acid anchors. The rates of repeat surgery with PLDLA anchors from Linvatec and PLDLA anchors from Arthrex were 24% and 4%, respectively. None of the patients treated with nonabsorbable suture anchors (polyether ether ketone or metallic) returned to the operating room (P < .001). After we controlled for associated factors in a multivariate analysis, the use of absorbable anchors, in particular poly-96L/4D-lactic acid anchors (OR, 14.7; P < .001), and having a work-related injury (OR, 8.1; P < .001) remained independent factors associated with both repeat surgery and revision superior labrum repair. CONCLUSIONS: Bioabsorbable PLDLA anchor material led to significantly more SLAP repair failures and reoperations compared with nonabsorbable suture anchors. Our recommendation is that glenoid labrum repairs be performed with nondegradable material and, specifically, that the use of anchors composed of PLDLA material should be avoided.

A comparative radiological assessment of polylactide pins over 3 years in vivo.

Biodegradable polylactide implants allow secure fixation of osteochondral fractures with minimal adverse effects. The goal of this prospective, randomized animal study was to show whether osteoconductive effects can be achieved through the development of poly-L/DL(70/30)lactide composite implants with 10% beta-tricalcium phosphate, and whether degradation can be positively influenced and adverse effects minimized using such implants. An additional goal was to clarify which radiological procedure is most suitable to observe the course of follow-up. Thirtysix medial femoral condyle osteotomies of sheep were fixed with either 3 poly-L/DL-lactide pins or 3 composite pins, and the pin canal widths were measured with conventional radiographs, with CT, MRI, and histologically after 3, 18, and 36 months. All fractures healed completely without displacement or clinically relevant complications. The pin canals dilated secondary to pin degradation at the 12th month, and then decreased in size later. At 36 months, the pins had microscopically disappeared, and the canals were filled with bone or scar tissue. There were no statistically significant differences between the pin-types. Poly-L/DL-lactide pins and composite C-pins are suitable for secure fixation of small osteochondral fractures. Osteoconductive effects of biocompatibility or osseous integration relating to composite development were not evident. Conventional radiography and computer tomography were suitable techniques for observation of pin canals. Due to frequently observed artifact, MRI was not suitable to observe the course of the implants.

Assessment of material- and technique-related complications following sagittal split osteotomies stabilized by biodegradable polylactide screws.

OBJECTIVE: The aim of this retrospective clinical study was to determine whether there are any material-related problems and increased occurrence of postoperative mandibular nerve and temporomandibular joint dysfunctions in connection with the use of biodegradable self-reinforced poly-L-lactide (SR-PLLA) screws for bone fixation after bilateral sagittal split osteotomies (BSSO). STUDY DESIGN: Forty consecutive patients who underwent BSSO and mandibular advancement that included fragment fixation using SR-PLLA screws were monitored for an average of 2.2 years postoperatively. RESULTS: The osteotomy sites healed uneventfully with no adverse reactions. The incidence of postoperative sensory disturbances of the inferior alveolar nerve was 27%. Symptoms of temporomandibular joint disorders (TMJD) observed preoperatively in 73% of patients were reduced to 48% after surgery. CONCLUSION: The occurrence of postoperative sensory disturbances and TMJD symptoms in this study did not deviate strikingly from that of other studies using conventional osteosynthesis. No specific complications related to the screw material were observed.

New tubular bioabsorbable knitted airway stent: feasibility assessment for delivery and deployment in a dog model.

PURPOSE: The aim of this study was to determine whether it is possible to deliver and deploy a new device, a poly-L-lactic acid (PLLA) tubular knitted airway stent, under bronchoscopic guidance in a dog model. DESCRIPTION: The delivery system consisted of a flexible balloon catheter (controlled radial expansion balloon dilator, M00558440, Boston Scientific Corporation, MA, USA) preloaded with a stent. A delivery catheter preloaded with a stent was advanced to a target point in the trachea under bronchoscopic guidance. Once the stent was positioned, the balloon was inflated for sixty seconds. The stent was in full contact with the tracheal wall upon deflation of the balloon. EVALUATION: The stents were successfully delivered into the tracheal lumen and successfully deployed in all dogs. CONCLUSIONS: This is the first study to prove the feasibility of delivering and deploying the PLLA stents in a dog model, using a balloon expansion technique. Further investigation with large numbers of subjects and long-term follow-up will be necessary to assess the utility of the bioabsorbable knitted tubular stent before clinical applications begin.