Risk factors for kyphosis recurrence after implant removal in percutaneous osteosynthesis for post-traumatic thoracolumbar fracture.

PURPOSE: Short-segment minimally invasive percutaneous spinal osteosynthesis has now become one of the treatments of choice to treat thoracolumbar fractures. The question of implant removal once the fracture has healed is still a matter of debate since this procedure can be associated with loss of sagittal correction. Therefore, we analyzed risk factors for kyphosis recurrence after spinal implants removal in patients treated with short-segment minimally invasive percutaneous spinal instrumentation for a thoracolumbar fracture. METHODS: A total of 32 patients who underwent implant removal in percutaneous osteosynthesis for post-traumatic thoracolumbar fracture were enrolled in our study. Patient's medical record, operative report and imaging examinations carried out at the trauma and during the follow-up were analyzed. RESULTS: Every patient experienced fracture union. Vertebral kyphotic angle (VKA) and Cobb angle (CA) improved significantly after stabilization surgery. VKA, CA, upper disk kyphotic angle (UDKA) and lower disk kyphotic angle (LDKA) significantly gradually decreased during follow-up. Traumatic disk injury (p: 0.001), younger age (p: 0.01), canal compromise (p: 0.04) and importance of surgical correction (p < 0.001) were significantly associated with kyphosis recurrence after implant removal. Anterior body augmentation did not affect loss of correction (CA and VKA) during the follow-up period (p: 0.57). CONCLUSION: Despite correction of the fracture after stabilization, we observed a progressive loss of correction over time appearing even before implant removal. Particular attention should be paid to post-traumatic disk damage or canal invasion, to young patients and to surgical overcorrection of the traumatic kyphosis.

Thermal implant removal in a pig jaw: a proof of concept study.

OBJECTIVES: The aim of this study was to evaluate whether thermal implant removal of osseointegrated implants is possible using a diode laser with an specific temperature-time interval. MATERIALS AND METHODS: First, tooth extraction of the first three premolars was performed in the maxilla and mandible on both sides of 10 pig. After 3 months, implants were inserted into the upper and lower jaws of 10 pigs. After 3 more months, osseointegrated implants were heated with a laser device to a temperature of 50 °C for 1 min. After 14 days, the implant stability quotient (ISQ), torque-out values, and bone-to-implant contact (BIC) ratio were assessed using resonance frequency analysis. RESULTS: ISQ values showed no significant differences within each group or between the control and test groups. Furthermore, torque-out and BIC value measurements presented no significant differences between the groups. CONCLUSIONS: At 50°C, changes in the BIC values were noticeably smaller; however, these differences were not significant. Future studies should evaluate the same procedures at either a higher temperature or longer intervals. CLINICAL RELEVANCE: With only 50 °C for 1 min, a dental implant will not de-integrate predictably.

New generation of superior single plating vs. low-profile dual minifragment plating in diaphyseal clavicle fractures: a biomechanical comparative study.

BACKGROUND: Recently, a new generation of superior clavicle plates was developed featuring the variable-angle locking technology for enhanced screw positioning and a less prominent and optimized plate-to-bone fit design. On the other hand, minifragment plates in dual plating mode have demonstrated promising clinical results. The aim of the current study was to compare the biomechanical competence of single superior plating using the new-generation plate vs. dual plating using low-profile minifragment plates. METHODS: Sixteen paired human cadaveric clavicles were pairwise assigned to 2 groups for instrumentation with either a superior 2.7-mm variable-angle locking compression plate (group 1), or with one 2.5-mm anterior combined with one 2.0-mm superior matrix mandible plate (group 2). An unstable clavicle shaft fracture (AO/OTA 15.2C) was simulated by means of a 5-mm osteotomy gap. Specimens were cyclically tested to failure under craniocaudal cantilever bending, superimposed with bidirectional torsion around the shaft axis, and monitored via motion tracking. RESULTS: Initial construct stiffness was significantly higher in group 2 (9.28 ± 4.40 N/mm) compared to group 1 (3.68 ± 1.08 N/mm), P = .003. The amplitudes of interfragmentary motions in terms of axial and shear displacement, fracture gap opening and torsion, over the course of 12,500 cycles were significantly higher in group 1 compared to group 2, P ≤ .038. Cycles to 2 mm shear displacement were significantly lower in group 1 (22,792 ± 4346) compared to group 2 (27,437 ± 1877), P = .047. CONCLUSION: From a biomechanical perspective, low-profile 2.5/2.0-mm dual plates could be considered as a useful alternative for diaphyseal clavicle fracture fixation, especially in less common unstable fracture configurations.

Total Capsulectomy Without Drains is a Safe Technique Facilitated by Pectoralis Major Muscle Repair.

BACKGROUND: The number of breast implant removal and capsulectomy procedures continues to increase rapidly. The aim of explant surgery should be to optimise patient outcomes from both an aesthetic and functional perspective. OBJECTIVES: To confirm the safety of drainless total capsulectomy and to determine the role of muscle repair in explant outcomes following the removal of sub-pectoral or dual-plane cosmetic breast implants. METHODS: We conducted a retrospective evaluation of our technique between January 2021 and November 2023. We report a single surgeon series of 140 consecutive cases of cosmetic breast implant removal from dual-plane or sub-pectoral pockets, all performed with total capsulectomy. In each case, meticulous repair of the Pectoralis major muscle was performed following capsulectomy. Drains were not used in any case. All patients were followed up for a minimum of 3 months. Patient satisfaction was assessed a minimum of 6 months post-operatively. RESULTS: By performing the described drainless technique, there were no cases of seroma, haematoma, pneumothorax or cosmetic breast distortion in this series. 83% of patients were treated as day cases and patient satisfaction with outcomes was high. CONCLUSIONS: Total capsulectomy without the use of drains is a novel and safe approach, aided by careful repair of the Pectoralis major muscle. There is no increased risk of seroma. The muscle repair may help to prevent post-explant cosmetic deformity of the breast. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Contextualizing the Impact of Pop Culture on Breast Implant Illness and its Medical Relevance.

INTRODUCTION: Despite a lack of data demonstrating causation, there is growing concern over breast implants and systemic illness. This study examines the impact of rising public interest in breast implant illness (BII) and its implications on breast implant removals (BIR). METHODS: A Google Trends (GT) analysis of each year between 2010 and 2022 was performed globally, and then separately for the United States alone (US), using the search terms "capsular contracture," "breast implant illness," and "breast implant(s) removal". Linear regression was performed to determine significant correlations. Data on BII-related Facebook advocacy groups, relevant pop culture events, numbers of BIR surgeries, and number of BII-related publications were collected and analyzed alongside GT data to determine relevance. RESULTS: For global GT, there was a significant relationship between "breast implant illness" and "breast implant(s) removal" in 2016 (R2=0.62, ß =0.33, p<0.01), 2020 (R2=0.53, ß =0.23, p=0.01), and 2022 (R2=0.60, ß =0.44, p=0.01). In the US, 2016 (R2=0.53, ß =1.75, p=0.01) 2018 (R2=0.61, ß =1.93, p<0.01) and 2020 (R2=0.72, ß=0.91, p<0.01) were significant. In 2020, "capsular contracture" and "breast implant(s) removal" was significant in the US (R2=0.58, ß=0.4, p=0.01). In 2016, Facebook was the platform for the largest BII advocacy group and in 2020 YouTube was the platform for the first BII documentary and TEDx talk. From 2010 to 2020, PubMed publications containing "ASIA" and "BII" increased 24-fold and ASPS reports on BIR rose 70%. CONCLUSION: This study suggests that BII is a topic of global concern and has implications on both academic medicine and clinical practice. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Breast Implant Removal-Only: The Role of Targeted Compression.

BACKGROUND: The number of women seeking explantation of their breast implants has increased in recent years. Anxiety due to potential health problems has been one of the major catalysts. Mastopexy with or without autoaugmentation and fat grafting are the main techniques used in breast implant removal surgery. OBJECTIVES: To analyse the aesthetic and satisfactory outcomes after simple breast implant removal assisted by targeted compression. METHODS: Twenty-eight patients were included in the series. Targeted compression of the breast after implant removal was performed during the 1st month. A satisfaction survey using a Likert scale was used before and after the final visit. The patients were followed up for 1 year. RESULTS: The mean age of the patients was 41 years old, and the mean time between implantation and removal was 10 years. Subjective reasons for removal (46.4% of the patients) were more frequent in women with less time since implantation (5 years) versus 15 years for implant-related problems. A total of 57.14% of the women were satisfied with the aesthetic result, and 42.86% were very satisfied. Only 17.8% of the total would consider an aesthetic refinement. CONCLUSIONS: Simple breast implant removal yields good aesthetic outcomes, and patients are satisfied with the results. Good management of compression of the breast and close follow-up to treat any collection in the pocket provides good adhesion and allows for effective management of the process of deflation and setting of the breast mound. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Reasons for Silicone Breast Implant Removal After Long-Term Implantation in Chinese Patients Without Complications: A Questionnaire-Based Study.

BACKGROUND: There are few studies of Chinese patients who request silicone breast implant removal after at least 10 years of implantation without any complications. This study aimed to study the characteristics of these patients, explore their reasons for breast implant removal and associate factors that affect their choice, so as to provide valuable information on clinical decision making. METHODS: A total of 55 eligible female patients (110 breasts) were enrolled from 2016 to 2022. A preoperative questionnaire survey before removal surgery and a telephone follow-up 1 year after removal surgery were conducted to collect data. RESULTS: The mean age of the patients was 40.6±8.8 years with the average time from breast augmentation to implant removal or replacement ranged from 10 to 15 years. Concerns about the aging of silicone gel-filled breast implant and the adverse effects of its long-term placement on body health were the top two reasons for breast implant removal. 63% of patients refused implant replacement, who were nearly 10 years older than those accepted implant replacement (p<0.05). Older age at implant removal (OR=0.67; 95%CI: 0.44-0.89) and a history of basic diseases (OR=0.02; 95%CI: 0.00-0.39) were statistically associated with lower rate of implant replacement. CONCLUSIONS: Concerns about the aging of silicone gel-filled breast implant were the main reason for uncomplicated patients to remove their breast implants. A comprehensive analysis based on patient's subjective choice and physical condition was suggested when an uncomplicated patient asks for implant removal. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Elective implant removal in the upper extremity: only symptomatic patients benefit.

PURPOSE: Elective implant removal (IR) in the upper extremity remains controversial. Implants in the olecranon and clavicle are commonly removed for prominence, unlike in the distal radius. Patient-reported symptomatic cannot be verified, and nonspecific discomfort remains unquantified. In this study, indications and outcomes of IR at the clavicle, olecranon and distal radius were evaluated, with a focus on postoperative patient satisfaction. MATERIALS AND METHODS: In this retrospective, single-center cohort study, patients, who received elective IR of the clavicle, olecranon and distal radius were included. Patients were followed up at least six weeks after IR. Outcomes included patient satisfaction, symptom resolution, and complications. RESULTS: One hundred and eighty-nine patients were included. Unspecific symptoms of discomfort were the most prevalent indication for IR (48.7%), followed by pain (29.6%) and objective limited range of motion (ROM) (7%). Pain and limited ROM combined was observed in 13.8%. Subjective benefit following IR was described in 54%. Patients with limited ROM (OR 4.7, p < 0.001) or pain (OR 4.1, p < 0.001) were more likely to experience alleviation of complaints. Patients with unspecific symptoms of discomfort, often did not report improvement. Major complications occurred in 2%. Refractures were detected at the clavicle (3.7%) and at the olecranon (2.5%). Minor complication rate was 5%. CONCLUSION: IR is a safe procedure in the upper extremity. Indications based on unspecific symptoms of discomfort have a significant lower rate of patient satisfaction postoperatively. Elective IR should be considered cautiously, if it is driven primarily by unspecific symptoms of discomfort. Patient education is relevant to prevent dissatisfying outcome.

Breast Lift Algorithm for the Treatment of Breast Implant Illness Requiring Implant Removal.

BACKGROUND: The recommendation of breast lift surgery in the setting of patients requiring breast implant removal is twofold. First, a breast lift is indicated for patients who present with breast mound or nipple-areolar complex ptosis. Second, a breast lift is indicated to accommodate the forecasted redundancy in skin and breast ptosis created by implant explantation. The most popular approaches to mastopexy include the inferior and superior pedicled breast lifts. We present a surgical algorithm with diagrams and cases clarifying mastopexy approaches for patients desiring breast implant removal in patients presenting with breast implant illness syndrome. METHODS: An algorithm was developed to explain the process for selecting the ideal pedicle approach for mastopexy and implant removal surgeries. RESULTS: Three cases are presented to illustrate the application of each pedicle under different presentations and goals. CONCLUSIONS: Advantages of an inferior pedicle include the capacity for unlimited lifting of the nipple-areola complex and for preservation of maximal breast mound volume. Its disadvantages include the inability to remove the breast capsule simultaneously and contraindicated if the lower breast pole is contracted. The advantages of a superior pedicle include the ability to remove the entire capsule and to eliminate lower breast pole if it is contracted. Its disadvantages include limitations to how high the nipple-areola complex can be lifted and the inability to preserve maximal breast mound volume. With the current trend for the request of implant removal in patients presenting with breast implant illness syndrome, the algorithm presented may assist surgeons with selecting the ideal breast lift and implant removal approach. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Implant removal after short percutaneous pedicle fixation associated with SpineJack® kyphoplasty: is correction sustained?

PURPOSE: This study objective was to evaluate sagittal correction loss after instrumentation removal in patients treated for thoracic or lumbar compression fractures treated with SpineJack® kyphoplasty associated with short percutaneous pedicle screw fixation. METHODS: This retrospective multicenter study was carried out in three major French trauma centers. All patients with a single type A thoracic or lumbar fracture, treated by the studied technique between 2017 and 2020, have been included. Demographic data, fracture type, removal procedure achievement and term were collected. Radiological parameters were measured at five timepoints: pre-operative, intra-operative, immediate post-operative, early post-operative (< 3 months) and at follow-up (1 year). Vertebral wedge angle (angle between the two endplates of the fractured vertebra) and traumatic regional angulation (TRA-calculated by subtracting regional kyphosis from the physiological reference values). RESULTS: 150 patients were included. Mean age was 48.6 ± 17.8 years. Average follow-up was 14.4 ± 3 months. 82 patients had secondary instrumentation removal. Mean time to removal was 6.4 ± 2.4 months. TRA correction loss between immediate post-operative and last follow-up was greater in removal group: 5.1 ± 5.6° versus 2.7 ± 4.7° (p = 0.01). Material was removed earlier in younger patients (p = 0.002). TRA correction loss was similar in the early and late removal groups (p = 0.83). Multivariate analysis identified only Magerl/AO A3 fractures as risk factor for loss of TRA correction (p = 0.007). CONCLUSION: Instrumentation removal was associated with good radiological outcomes with a non-significant loss of vertebral wedge angle and tolerable loss of traumatic regional angulation (+ 2.4° compared to the no-removal group), even if performed early.

Effectiveness of orthopedic implant removal surgery in patients with no implant-related symptoms after fracture union of isolated lower extremity shaft fractures: patient-centered evaluation.

INTRODUCTION: Routine orthopedic implant removal surgery (OIRS) in patients with no implant-related symptoms after union is controversial. Various factors, such as various fracture sites, fracture types, and accompanying fractures at other sites, act as error variables in the evaluation of routine OIRS. The purpose of this study is to evaluate the benefits of orthopedic implant removal surgery (OIRS) in patients with no implant-related symptoms such as infection and soft tissue irritation after union of isolated lower extremity shaft fractures from a patient-centered evaluation MATERIALS AND METHODS: Eighty-four patients who achieved fracture union after internal fixation of femoral shaft or tibial shaft fractures (March 2004 to December 2018) and who showed no implant-related symptoms were evaluated retrospectively. Minimum post-OIRS follow-up period was 1 year. Thirty-eight patients were treated with intramedullary nail and 13 were treated with plate and screws for femoral shaft fracture. Twenty patients were treated with intramedullary nail and 13 were treated with plate and screws for tibial shaft fracture. All patients subsequently underwent OIRS. Quality of life (QoL) and lower extremity pain using visual analogue scale (VAS) were evaluated 1 day before OIRS. Patient satisfaction with the OIRS, VAS, and QoL were assessed at least 1 year after OIRS using the SF-36 questionnaire. RESULTS: The physical component score, mental component score, and scores of all eight domains showed significant improvement after OIRS (p < 0.01). Patients with femoral shaft fractures tended to have lower pre- and post-OIRS SF-36 scores than those with tibial shaft fracture. Among patients with femoral shaft fracture, SF-36 scores were comparable in the nail and plate groups. Among patients with tibial shaft fracture, nail group showed relatively better QoL than the plate group, before and after OIRS in spite of several complications such as formation of scar tissue, nerve damage, and refracture. CONCLUSIONS: Patients with no implant-related symptoms showed significant improvement in QoL and satisfaction after OIRS. This suggests that OIRS is beneficial from the patients' evaluation. LEVEL OF EVIDENCE: Therapeutic Level II.

Analyzing risk factors for treatment failure in fracture-related infection.

INTRODUCTION: Fracture-related infection (FRI) represents a challenging clinical scenario. Limited evidence exists regarding treatment failure after initial management of FRI. The objective of our investigation was to determine incidence and risk factors for treatment failure in FRI. MATERIALS AND METHODS: We conducted a retrospective review of patients treated for FRI between 2011 and 2015 at three level 1 trauma centers. One hundred and thirty-four patients treated for FRI were identified. Demographic and clinical variables were extracted from the medical record. Treatment failure was defined as the need for repeat debridement or surgical revision seven or more days after the presumed final procedure for infection treatment. Univariate comparisons were conducted between patients who experienced treatment failure and those who did not. Multivariable logistic regression was conducted to identify independent associations with treatment failure. RESULTS: Of the 134 FRI patients, 51 (38.1%) experienced treatment failure. Patients who failed were more likely to have had an open injury (31% versus 17%; p = 0.05), to have undergone implant removal (p = 0.03), and additional index I&D procedures (3.3 versus 1.6; p < 0.001). Most culture results identified a single organism (62%), while 15% were culture negative. Treatment failure was more common in culture-negative infections (p = 0.08). Methicillin-resistant Staphylococcus aureus (MRSA) was the most common organism associated with treatment failure (29%; p = 0.08). Multivariate regression demonstrated a statistically significant association between treatment failure and two or more irrigation and debridement (I&D) procedures (OR 13.22, 95% CI 4.77-36.62, p < 0.001) and culture-negative infection (OR 4.74, 95% CI 1.26-17.83, p = 0.02). CONCLUSIONS: The rate of treatment failure following FRI continues to be high. Important risk factors associated with treatment failure include open fracture, implant removal, and multiple I&D procedures. While MRSA remains common, culture-negative infection represents a novel risk factor for failure, suggesting aggressive treatment of clinically diagnosed cases remains critical even without positive culture data. LEVEL OF EVIDENCE: Retrospective cohort study; Level III.

Intramedullary Screw Fixation Versus Traditional Plating for Distal Fibula Fractures.

The traditional method of treating fibular fractures in unstable ankle injuries involves open reduction and internal fixation with a plate and screw construct. Less invasive percutaneous fixation techniques with intramedullary fibular screws have been utilized for many years to reduce wound and implant complications while maintaining a stable ankle mortise. However, there have been no direct case-control studies comparing percutaneous intramedullary fibular screw fixation to the traditional open reduction and internal fixation with plates and screws. In our study, we compared radiographic and clinical outcomes for unstable ankle fractures in which the fibula fracture was treated with either a percutaneous intramedullary screw or by open reduction and internal fixation with a plate and screw construct. We retrospectively reviewed 69 consecutive patients from 2011 to 2019 with unstable ankle fractures treated with intramedullary fibular screws and compared them to 216 case-control patients treated with traditional plate and screw construct over the same time period. The average follow-up for the intramedullary screw group was 11.5 months and 15.2 months for the plate and screw group. We collected general demographic data, measured intraoperative and final follow-up talocrural angles, Kellgren-Lawrence osteoarthritis grade, union rates, implant removal rates, infection rates, and American Orthopedic Foot and Ankle Society ankle-hindfoot scores. The intramedullary screw group had a statistically significant lower rate of delayed implant removal (8.7% vs 23.6%) and there was no detectable difference in other measures.

Clinical comparison of double-plate fixation by the perpendicular plate method versus parallel plate method for distal humeral fracture: a multicenter (TRON group) study.

INTRODUCTION: Double-plating methods are popular, with perpendicular and parallel plate methods being widely used surgical method for the rigid fixation of distal humeral fracture (DHF). However, which plate method is better for DHF remains controversial. The aim of this study was to compare patient outcomes including the incidences of complications and reoperation between the two plate methods. METHODS: We extracted 383 patients with DHF undergoing surgery between 2011 and 2020 from our multicenter database, which is named TRON. We divided the subjects into two groups: perpendicular plating group (Group A) and parallel plating group (Group B). To adjust for baseline differences between the groups, patients were matched for age, sex, olecranon osteotomy, AO type, and type of injury. We assessed the Mayo Elbow Performance Score (MEPS) at 3 and 6 months and the last follow-up month as the clinical outcome. We investigated the incidences of complications and reoperations in both groups. RESULTS: After matching, each group comprised 50 patients. There was no significant difference between Group A versus Group B in MEPS score at each time point. The incidence of implant removal in Group B was higher than that in Group A (26.5% vs 50%, p = 0.023). DISCUSSION: Although there were no significant differences in clinical outcomes or complications between the two groups, the incidence of implant removal was higher in Group B than in Group A. In the parallel plate technique, where the plates have to be placed in areas with thin subcutaneous soft tissue, the incidence of implant removal might be high due to the discomfort caused by the implant.

Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial.

STUDY QUESTION: Is a mechanical hand-held device for removing a single-rod subdermal contraceptive implant safe for implant users? SUMMARY ANSWER: In terms of safety, the device is non-inferior to the standard technique for implant removal. WHAT IS KNOWN ALREADY: An easy-to-use device for removing a subdermal contraceptive implant may be helpful in settings where skilled providers are in short supply. Prior to this study, the only report on the world's first hand-held, mechanical device with build-in incisor was a Swedish study using earlier versions of the product. STUDY DESIGN, SIZE, DURATION: From December 2019 to November 2020, we conducted a three-arm, open-label non-inferiority randomized trial involving 225 Ugandan women to assess safety (primary outcome) and measure implant removal efficacy (secondary outcomes) of a newly developed, hand-held device, compared to the standard removal technique. PARTICIPANTS/MATERIALS, SETTING, METHODS: We randomized participants desiring removal of their one-rod contraceptive implant in a 1:1:1 ratio: standard technique/lidocaine injection, new device/lidocaine patch or new device/lidocaine injection. For primary safety endpoints, we examined removal complications and grouped them according to severity. For secondary endpoints on efficacy, we defined three device outcomes: intact implant removed without additional tools (primary), implant removed allowing implant breakage, but without tools (secondary) and implant removed allowing implant breakage and non-scalpel tools (tertiary). We assessed provider feedback on the device and used chi-square tests for all comparisons. MAIN RESULTS AND THE ROLE OF CHANCE: We recruited 225 participants and randomly assigned (n = 75) to each group. For safety, no primary complications occurred in any treatment group, while only one secondary complication occurred in each treatment group (1%). Primary efficacy was 100% (standard technique), 85% (new device/lidocaine patch) and 73% (new device/lidocaine injection) (P < 0.0001). Secondary efficacy was 100% (standard technique), 92% (new device/lidocaine patch) and 79% (new device/lidocaine injection) (P < 0.0001). Tertiary efficacy was 100% (standard technique), 96% (new device/lidocaine patch) and 91% (new device/lidocaine injection) (P = 0.017). Unsuccessful removals with the new device did not hinder subsequent implant extractions with standard back-up tools. In over 90% of the 150 device procedures, providers agreed or strongly agreed that the product is an acceptable alternative to standard removal technique. LIMITATIONS, REASONS FOR CAUTION: We tested a new removal device in the hands of Ugandan nurses who were adept at standard removal techniques; our estimates of removal efficacy may not apply to lower-level providers who arguably may be the prime beneficiaries of this technology. WIDER IMPLICATIONS OF THE FINDINGS: The study was conducted in a region of the world where the new device could be used to expand access to implant removal services. Intended beneficiaries of the new product are implant users who cannot easily find skilled providers for traditional scalpel-dependent removals and/or users who are intimidated by scalpel procedures, and lower-level providers who can be trained to help deliver services to meet a growing demand. The new device is a safe, acceptable alternative; efficacy was high, but not on par with standard technique. STUDY FUNDING/COMPETING INTEREST(S): Funding for this study was provided by the RemovAid AS of Norway with grants from Research Council of Norway (GLOBVAC number 228319), Bill & Melinda Gates Foundation (grant INV-007571) and SkatteFUNN. M.B. is founder and former CEO of RemovAid AS, Norway. M.B. holds contraceptive rod remover patents (2012 1307156.8 and 2015), pre-removal test (filed) and shares in RemovAid AS. All of the remaining authors' institutions received payments in the form of contracts to help conduct the study; the funds for these contracts emanated from RemovAid AS. TRIAL REGISTRATION NUMBER: NCT04120337. TRIAL REGISTRATION DATE: 9 October 2019. DATE OF FIRST PATIENT'S ENROLMENT: 23 December 2019.

Vacuum phenomenon as a predictor of kyphosis after implant removal following posterior pedicle screw fixation without fusion for thoracolumbar burst fracture: a single-center retrospective study.

BACKGROUND: Posterior pedicle screw fixation without fusion has been commonly applied for thoracolumbar burst fracture. Implant removal is performed secondarily after bone union. However, the occurrence of secondary kyphosis has recently attracted attention. Secondary kyphosis results in poor clinical outcomes. The purpose of this was to determine predictors of kyphosis after implant removal following posterior pedicle screw fixation without fusion for thoracolumbar burst fracture. METHODS: This retrospective study reviewed 59 consecutive patients with thoracolumbar burst fracture who underwent implant removal following posterior pedicle screw fixation without fusion. Inclusion criteria were non-osteoporotic fracture and T11-L3 burst fracture. Old age, sex, initial severe wedge deformity, initial severe kyphosis, and vacuum phenomenon were examined as factors potentially associated with final kyphotic deformity (defined as kyphotic angle greater than 25°) or loss of correction. Logistic regression analysis was performed using propensity score matching. RESULTS: Among the 31 female and 28 male patients (mean age 38 years), final kyphotic deformity was found in 17 cases (29%). Multivariate analysis showed a significant association with the vacuum phenomenon. Loss of correction was found in 35 cases (59%) and showed a significant association with the vacuum phenomenon. There were no significant associations with other factors. CONCLUSIONS: The findings of this study suggest that the vacuum phenomenon before implant removal may be a predictor of secondary kyphosis of greater than 25° after implant removal following posterior pedicle screw fixation without fusion for thoracolumbar burst fracture, but that old age, sex, initial severe kyphosis, and initial severe wedge deformity may not be predictors.

Functional outcomes before and after implant removal in patients with posttraumatic shoulder stiffness and healed proximal humerus fractures: does implant material (PEEK vs. titanium) have an impact? - a pilot study.

BACKGROUND: Posttraumatic shoulder stiffness remains a problem after proximal humerus fracture (PHF) despite good healing rates. The aim of this pilot study was to determine whether the implant material and overlying soft tissue have an effect on shoulder range of motion (ROM) before and after implant removal (IR). METHODS: 16 patients (mean age 55.2 ± 15.3 (SD) years; 62.5% female) were included who underwent operative treatment with locking plates of either carbon fiber reinforced Polyetheretherketone (PEEK) (PEEKPower® humeral fracture plate, Arthrex, Naples, Florida, USA, n = 8) or titanium alloy (Ti) (Philos®, DePuy Synthes, Johnson & Johnson Medical, Raynham, Massachusetts, USA, n = 8) for PHF. All patients presented with a limited ROM and persistent pain in everyday life after the fracture had healed, whereupon IR was indicated. ROM before and after IR were compared as well as the Constant Score (CS) and the CS compared to the contralateral shoulder (%CS) 1 year after IR. RESULTS: In group PEEK, elevation was 116.3° ± 19.2° pre- and 129.4° ± 23.7° post-IR (p = 0.027). External rotation was 35.0° ± 7.6° pre- and 50.6° ± 21.8° post-IR (p = 0.041). External rotation with the humerus abducted 90° was 38.8° ± 18.1° pre- and 52.5° ± 25.5° post-IR (p = 0.024). In group Ti, elevation was 110.0° ± 34.6° pre- and 133.8° ± 31.1° post-IR (p = 0.011). External rotation with the humerus at rest was 33.8° ± 23.1° pre- and 48.8° ± 18.7° post-IR (p = 0.048). External rotation with the humerus abducted 90° was 40.0° ± 31.6° pre- and 52.5° ± 22.5° post-IR (p = 0.011). Comparison of the two implant materials showed no significant difference. The overall CS was 90.3 ± 8.8, the %CS was 91.8% ± 14.7%. CONCLUSION: There was no significant difference in ROM, CS and %CS with respect to plate materials, although lower cell adhesion is reported for the hydrophobic PEEK. However, all patients showed improved functional outcomes after IR in this pilot study. In patients with shoulder stiffness following locked plating for PHF, implants should be removed and open arthrolysis should be performed, independently from the hardware material. LEVEL OF EVIDENCE: II.

One-Stage Mastopexy-Lipofilling after Implant Removal in Cosmetic Breast Surgery.

INTRODUCTION: Revising unsatisfactory outcomes in breast augmentation represents one of the most challenging procedures in aesthetic breast surgery. Different techniques for revising unsatisfactory outcomes in breast augmentation have been described, which can be summarized in two options: implant replacement procedures and implant explantation procedures. Implant explantation procedures can be performed alone or in combination with other techniques to restore volume. Depending on the native volume, the shape and the elasticity of the remaining breast tissue, implant removal can be also associated with mastopexy, auto-augmentation mammoplasty or fat graft. This article portrays our series of combined mastopexy and lipofilling after implant explantation for revising unsatisfactory outcomes of breast augmentation. MATERIAL AND METHOD: A prospective observational study was performed including all patients underwent cosmetic one-stage mastopexy-lipofilling after implant removal. Collected data included patient's age and BMI, smoking, previous scar location (periareolar, inframammary fold or trans-axillary), implant characteristics (size and location), reason why patient wants to remove the implant (capsular contracture, implant rupture, animation deformity, chronic pain, asymmetry), mean liposuction and fat injection volume, type of capsulectomy, mean operating time and postoperative complications. Cosmetic results and patient satisfaction were evaluated using the 5 points Likert scale and BreastQ reduction/mastopexy module, respectively. RESULTS: A total of 14 patients (28 breasts) were included with a mean follow-up of 11.3 months. Mean liposuction and injection volumes were 980 mL and 295 mL, respectively. Regarding breast volume, a reduction in one-cup size was noted in 100% of cases. Only one patient (7.69%) requested additional breast volume and underwent a second fat grafting session. Regarding aesthetic outcomes, the mean scores for breast volume, shape, symmetry, quality of scars, nipple-areola complex and donor site shape were 4.2, 4.2, 4.9, 4, 4.3 and 4.7, respectively. BreastQ showed an improvement of patients reported satisfaction with a median (Quartile Rank) score increase of 19 points for the "satisfaction with breast" domain (p < .00001) and a decrease of 17 points for the "physical well-being" domain (p < .00001). "Satisfaction with outcomes" median (Quartile Rank) score was 72. CONCLUSION: Combined mastopexy and lipofilling after implant removal represents a new tool in plastic surgeon armamentarium. This technique is indicated in patients who do not desire anymore breast implant, presenting ptosis of the remaining breast gland and donor site availability. Our article suggested that combined mastopexy and lipofilling achieves satisfactory aesthetic results and excellent patient-reported outcomes. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The Ultrasound Evolution of Lateral Thoracic Perforator Flaps Design and Harvest for Partial and Total Breast Reconstruction.

BACKGROUND: The lateral thoracic area is a known source for perforator flaps for partial breast reconstruction. In this paper, we report our experience in designing and harvesting lateral thoracic perforator flaps for partial and total breast reconstruction with the introduction of the "propuller" concept. PATIENTS AND METHODS: Between September 2013 and August 2021, 95 flaps were performed for immediate, partial and total breast reconstruction. On a total of 95 flaps, 30 (19 thoracodorsal artery perforator(TDAP) flaps, 10 lateral intercostal artery perforator(LICAP) flaps and 1 lateral thoracic artery perforator(LTAP) flap) were harvested in the traditional fashion (control group) and 65 (57 LICAP, 2 LTAP and 6 TDAP flaps) according to the propeller concept (study group). All cases were preoperatively planned with Color-Coded Duplex Ultrasound. RESULTS: No flap losses were experienced in both groups. The mean operative time was 156 minutes (range 118-234) for the control group and 75 minutes (range 53-125) for the study group (p < 0.0001). A significantly higher number of LICAP flaps were chosen in the study group compared to control group. None of the patients had donor site complications. Patients' and Surgeons' satisfaction was high to very high. CONCLUSION: The ultrasound preoperative planning led to the development of an easier and safer method of local perforator flap harvesting, that we named as propuller design. Its novelty lies in that perforator intraoperative selection and fully skeletonization are not needed and a more efficient flap movement (propeller plus advancement) which transfers more tissue into the new breast can be achieved safely, faster and easier.

Does implant removal of superior clavicle plate osteosynthesis affect the functional outcome: a prospective trial.

BACKGROUND: Elective implant removal (IR) accounts for up to 30% of all orthopaedic surgeries. While there is general acceptance about the need of implant removal for obvious reasons, such as infections or implant failure, little is known about the beneficial aspects in cases of minor reasons such as patients' wish for IR. Therefore, we initiated this study to define patients' benefit of elective implant removal following plate osteosynthesis of displaced clavicle fractures. PATIENTS AND METHODS: Prospective evaluation of patients was conducted before implant removal and 6 weeks postoperative. Subjective and objective criteria included pain rating on a visual analogue scale (VAS) and active range of motion (ROM) pre- and 6 weeks postoperative. Functional scoring included Constant-Murley Score, DASH (Disabilities of Arm, Shoulder and Hand Score), MSQ (Munich Shoulder Questionnaire) and SPADI (Shoulder Pain and Disability Index). RESULTS: 37 patients were prospectively enrolled in this study and implant removal was performed after 16 ± 6.1 months. No re-fractures nor other complications were detected during routine follow up. Functional outcome increased through all scores (Constant score 73.3 ± 14.6 preoperative to 87.4 ± 12.0 postoperative (p = 0.000), MSQ 85.0 ± 7.3 preoperative to 91.8 ± 9.0 postoperative (p = 0.005), DASH Score 7.4 ± 8.2 preoperative to 5.7 ± 9.5 postoperative (p = 0.414), SPADI 93.4 ± 6.6 preoperative to 94.0 ± 10.1 postoperative (p = 0.734). CONCLUSIONS: Discomfort during daily activities or performing sports as well as limited range of motion were the main reasons for patients' wish for implant removal. We found increased functional outcome parameters and decreased irritation after implant removal. Therefore we suggest implant removal in case of patients' wish and completed fracture consolidation. TRIAL REGISTRATION: Trial registration no: NCT04343118, Retrospective registered: www.clinicaltrials.gov .