Average 3-year Follow-up Research Articles

Cementless Metal-Backed Patellar Components in Primary Total Knee Arthroplasty: An Average 10-Year Follow-Up

BackgroundHistorically, 1st generation metal-backed cementless patellar implants demonstrated high failure rates due to multiple factors. The 2nd generation cementless implants were developed with purported improvements in component design and polyethylene wear characteristics. This study evaluated clinical results of a current generation cementless metal-backed patellar implant with a minimum 5-year follow-up. MethodsOne hundred and thirty-six primary total knee arthroplasties (TKAs) with metal-backed cementless patellae were compared to 183 cemented patellae with the same implant design. The cementless group mean age was 61 years (range, 40 to 81), mean body mass index (BMI) of 34.9 (range, 22.6 to 64.5), and mean follow-up of 10 years (range, 5 to 13). The cemented group mean age was 65 years (range, 32 to 89), mean BMI of 32.5 (range, 18.2 to 56.6), and mean follow-up of 10 years (range, 5 to 12). Significant demographic differences of age (P < .001), BMI (P < .01), and sex (P < .001) were found, with cementless patients being younger, heavier, and with more men. ResultsThere were no statistical differences in non-revision procedures (P = .214), TKA revisions (P = .639), patellar revisions (P = .151), and patellar aseptic loosening (P = .737). The 10-year survivorship of the cementless metal-backed patella was 95.9% with all-cause failure as the endpoint. The 10-year survivorship of the cemented patellar component was 98.9%. ConclusionThis study demonstrated noninferiority of a 2nd generation HA-coated cementless metal-backed patellar implant in primary TKA compared to cemented patellae with 10-year survivorship of 95.9%. Advances in implant design and polyethylene wear properties have led to improved clinical results with metal-backed patellar components in primary TKA.

Risk factors for recurrence of periprosthetic joint infection following operative management: a cohort study with average 5-year follow-up.

Periprosthetic joint infections (PJIs) remain challenging to eradicate even after surgical management, which in most cases involves either debridement, antibiotics and implant retention (DAIR) or single- or two-staged revision. The purpose of this study is to determine predictors of PJI recurrence after operative management for PJI, and to determine differences in recurrence-free survival between DAIR and staged revision. This is a retrospective analysis of prospectively collected data of revision hip and knee arthroplasty surgeries due to PJI between 2011 and 2018 at an academic hospital. Any patient undergoing revision surgery for PJI was included except if the index surgery information was unknown. The primary outcome was confirmed PJI recurrence. Multivariable logistic regression analysis was utilized to determine the relationship between the predictor variables and outcome variable. Log rank testing was used to compare recurrence-free survival between DAIR and staged revision. A total of 89 patients (91 joints) underwent revision surgery due to PJI. Younger age and presence of a sinus tract were statistically significant for risk of PJI recurrence. A multivariable logistic regression model including both variables was significant for predicting recurrence of PJI (χ2=10.2, P=0.006). Survival was not significantly different between patients who underwent DAIR versus a staged revision. Younger patients and those with a chronic sinus tract are at significantly higher risk of recurrent PJI. This study also demonstrated that PJI can be successfully managed in the majority of cases with DAIR or staged revision.

Analysis of factors related to the decision of Hartmann's procedure and its reversal: a single-center experience.

Hartmann's procedure (HP) is commonly applied to resolve acute clinical conditions in most cases with colonic obstruction or perforation. HP and the closure of the end colostomy are associated with high morbidity-mortality rates. In our study, we aimed to report our clinical experience in HP. Demographic data and outcomes of Hartmann procedures performed between 2015 and 2023 were retrospectively reviewed. The median age of our study was 63 (18-94) years; 65 of the patients were female, and 97 were male. Colorectal malig-nancies were the primary etiology in 50% of patients who underwent HP, with 70% presenting with obstruction and 30% with perfora-tion. Two-thirds of the patients were American Society of Anesthesiologists-2 or higher. Postoperative complications did not develop in 74.7% of patients. Our mortality rate was 33.3%. The colostomy was closed in 59 patients during an average 2-year follow-up. The median closure time was 311 (57-1319) days. A stapler was used in 89.8% of patients during the closure. A diverting ileostomy was created in only two patients. The median hospital stay was 8 (5-70) days. Post-operative complications did not develop in 25.4% of patients, while four patients died. In our population, HP was more commonly performed for colorectal cancer. The procedure and closure of the ostomy result in low stoma closure rates, high morbidity, and mortality rates, as well as surgical difficulties.

Association of serum uric acid with the risk of developing hypertension: A prospective cohort study with mediation analysis.

Elevated serum uric acid (SUA) is associated with the incidence of hypertension, but whether relevant metabolic factors have mediating effects is not certain. Our study was based on a functional community cohort established in Beijing. In 2015, a total of 7482 individuals without hypertension were recruited and followed up until 2019. Multivariate logistic regression analysis was used to investigate the association between SUA and hypertension. Cross-lagged panel analysis and mediation analysis were used to explore the effects of metabolic factors on the association between SUA and incident hypertension. During the average 4-year follow-up, the cumulative incidence of hypertension was 10.9% (n = 580). SUA was an independent risk factor for hypertension, and the RRs (95% CI) for subjects with baseline SUA levels in quartile 2, quartile 3 and quartile 4 were 1.20 (0.88-1.63), 1.50 (1.10-2.05), and 1.57 (1.11-2.22) compared to those in quartile 1, respectively. The cross-lagged panel analysis showed that the increases in Cr, TG, LDL, ALT, AST and WBC occurred after SUA increased (P < 0.001). Among these factors, TG, WBC and ALT played an intermediary role in both men (TG: 14.76%; WBC: 11.61%; ALT: 15.93%) and women (TG: 14.55%; WBC: 8.55%; ALT: 6.89%). The elevated SUA concentration was an independent risk factor for hypertension in the Chinese population, and TG, WBC and ALT had important mediating effects on the association between SUA and hypertension.

Risk scores of incident mild cognitive impairment in a Beijing community-based older cohort.

Objective: It is very important to identify individuals who are at greatest risk for mild cognitive impairment (MCI) to potentially mitigate or minimize risk factors early in its course. We created a practical MCI risk scoring system and provided individualized estimates of MCI risk.Methods: Using data from 9,000 older adults recruited for the Beijing Ageing Brain Rejuvenation Initiative, we investigated the association of the baseline demographic, medical history, lifestyle and cognitive data with MCI status based on logistic modeling and established risk score (RS) models 1 and 2 for MCI. We evaluated model performance by computing the area under the receiver operating characteristic (ROC) curve (AUC). Finally, RS model 3 was further confirmed and improved based on longitudinal outcome data from the progression of MCI in a sub-cohort who had an average 3-year follow-up.Results: A total of 1,174 subjects (19.8%) were diagnosed with MCI at baseline, and 72 (7.8%) of 849 developed MCI in the follow-up. The AUC values of RS models 1 and 2 were between 0.64 and 0.70 based on baseline age, education, cerebrovascular disease, intelligence and physical activities. Adding baseline memory and language performance, the AUC of RS model 3 more accurately predicted MCI conversion (AUC = 0.785).Conclusion: A combination of risk factors is predictive of the likelihood of MCI. Identifying the RSs may be useful to clinicians as they evaluate their patients and to researchers as they design trials to study possible early non-pharmaceutical interventions to reduce the risk of MCI and dementia.

Culture-negative Peri-prosthetic Joint Infection after Total Hip Arthroplasty Treatment Protocol and Outcomes in Acute and Chronic Cases.

The treatment of culture-negative periprosthetic joint infections (CN PJI) of the hip represents complex entities. We, as a result of this, report on 12 cases. Irrigation and debridement (I&D) with implant retention were performed in acute cases and two-stage revisions in chronic infections. Combined antibiotic therapy was administered in all cases for 12 weeks. Infection control was achieved in all patients with an infection-free rate of 100% at 7.5 years of average follow-up.

Cementless femoral neck endoprosthesis SPIRON in men in aspects of clinical status and quality of life in an average 7-year follow-up

BackgroundWe report the clinical evaluation, quality of life and pain assessment in patients who had a femoral neck SPIRON endoprosthesis.MethodsThe study group consisted of 27 men in whom 35 femoral neck endoprosthesis were implanted (8 on the left side, 12 on the right side and 7 bilateral) due to idiopathic osteoarthritis of the hip (20 patients) or avascular femoral osteonecrosis (7 patients) in a mean 7-year follow-up.ResultsThe median pre-operative Harris Hip score (HHS) was 35.5 and post-operative 98.5 (p < 0.001). The median WOMAC HIP score was pre-operatively 57 and post-operatively 0 (p < 0.001). The median SF-12 score was pre-operatively 4 and post-operatively 33 (p < 0.001). The median pain assessment in VAS scale was 7 pre-operatively and 0 post-operatively (p < 0.001).ConclusionsThe results of all examined patients have changed significantly in every category showing that SPIRON endoprosthesis improved their quality of life and statistically reduced pain ailments. Moreover we have proved that higher BMI (> 30) is associated with worse operation outcomes.

Subtalar arthroereisis in pediatric flexible flat foot: Functional and radiographic results with 5 years of average follow-up

The aim of this retrospective study is to evaluate the clinical-functional and radiographic results in pediatric patients with painful and disabling Flexible Flat Foot (FFF) refractory to conservative treatment who underwent percutaneous subtalar arthroereisis with a Maxwell Brancheau Arthroereisis® (MBA) implant. Patients aged 8–14 years old with a minimum follow-up of 24 months were included. A pre and postoperative radiographic evaluation was carried out analyzing Meary's angle, internal Moreau-Costa-Bartani´s angle, Talar declination angle, Calcaneal Pitch, Kite's angle, Talar-1st metatarsal angle, and Talonavicular coverage angle. In those patients with more than 5 years of follow-up, the development of subtalar osteoarthritis was evaluated. A clinical-functional evaluation was carried out using the American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot rating scale. Pre and postoperative pain was evaluated using the visual analog scale (VAS). Postoperative complications were described. Fourteen patients (19 feet) met the inclusion criteria. The mean age at surgery was 12 years old with a mean follow-up of 68.26 months. All radiographic angles improved significantly. No signs of subtalar osteoarthritis were identified. The mean pre and postoperative pain according to VAS was 7.05 and 0.77 respectively. The mean pre and postoperative AOFAS was 75.42 and 97.05 respectively. One female patient had persistent pain in both feet (VAS = 4). However, she was able to do sports and daily life activities without restrictions. None of the implants needed to be removed due to intolerance or pain. Subtalar arthroereisis seems to be effective to improve the clinical-functional and radiographic parameters in moderate pediatric FFF.

Outdoor ambient air pollution and breast cancer survival among California participants of the Multiethnic Cohort Study.

Within the Multiethnic Cohort (MEC), we examined the association between air pollution and mortality among African American, European American, Japanese American, and Latina American women diagnosed with breast cancer. We used a land use regression (LUR) model and kriging interpolation to estimate nitrogen oxides (NOx , NO2) and particulate matter (PM2.5, PM10) exposures for 3,089 breast cancer cases in the MEC, who were diagnosed from 1993 through 2013 and resided largely in Los Angeles County, California. Cox proportional hazards models were used to examine the association of time-varying air pollutants with all-cause, breast cancer, cardiovascular disease (CVD), and non-breast cancer/non-CVD mortality, accounting for key covariates. We identified 1,125 deaths from all causes (474 breast cancer, 272 CVD, 379 non-breast cancer/non-CVD deaths) among the 3,089 breast cancer cases with 8.1years of average follow-up. LUR and kriged NOX (per 50ppb) and NO2 (per 20ppb), PM2.5 (per 10µg/m3), and PM10 (per 10µg/m3) were positively associated with risks of all-cause (Hazard Ratio (HR) range=1.13-1.25), breast cancer (HR range=1.19-1.45), and CVD mortality (HR range=1.37-1.60). Associations were statistically significant for LUR NOX and CVD mortality (HR=1.60; 95% CI: 1.08-2.37) and kriged NO2 and breast cancer mortality (HR=1.45; 95% CI 1.02-2.07). Gaseous and PM pollutants were positively associated with breast cancer mortality across racial/ethnic group. In this study, air pollutants have a harmful impact on breast cancer survival. Additional studies should evaluate potential confounding by socioeconomic factors. These data support maintaining clean air laws to improve survival for women with breast cancer.

Long-term effect of immobilization in external rotation after first-time shoulder dislocation: an average 18-year follow-up.

Immobilization in external rotation (ER) after a first-time shoulder dislocation was introduced to reduce the risk of recurrence compared with immobilization in internal rotation (IR), but its efficacy remains controversial. The purpose of this study was to determine the long-term effect of immobilization in ER after a first-time shoulder dislocation. Between October 2000 and March 2004, 198 patients with a first-time anterior dislocation of the shoulder (average age 37) were randomly assigned to immobilization in ER (ER group = 104 shoulders) or IR (IR group = 94 shoulders) for 3 weeks. At an average 2-year follow-up, 159 patients (80.3%) were available for evaluation. In the current study, these 159 patients were further followed up and interviewed by telephone. The following items were evaluated: recurrent instability, apprehensive feeling, surgical intervention, limitation in the range of motion, return to sports, and the Single Assessment Numeric Evaluation (SANE) score. The average follow-up period was 18.2 years (range, 16-20 years). Fifty-six patients were available for follow-up with the follow-up rate of 35%. The number of recurrent patients was 6 of 27 (22%) in the ER group and 6 of 29 (21%) in the IR group (P = .889). The number of surgically stabilized patients was 3 of 27 (11%) in the ER group and 10 of 29 (34%) in the IR group (P = .038). In total, the recurrence rate was 33% (9 of 27) in the ER group and 55% (16 of 29) in the IR group (P = .100). Adding the surgical cases and those with the SANE score ≤70% as failure cases, the failure rate in the ER group (26%) was significantly lower than that in the IR group (52%) (P = .048). Among those who survived without surgical intervention, there were no significant differences in apprehensive feeling, return to sports, limited range of motion, and the SANE score between the groups. Immobilization in ER reduced the risk of surgical intervention compared with IR in the long term.

Open reduction and locked compression plate fixation, with or without allograft strut, for periprosthetic fractures in patients who had a well-fixed femoral stem: a retrospective study with an average 2-year follow-up

BackgroundThe use of cortical strut allograft has not been determined for Vancouver type B1 or C fracture. This study aimed to evaluate the short-term efficacy of locking compression plating with or without cortical strut allograft in managing these types of fractures.MethodsWe retrospectively assessed 32 patients (17 males, 15 females; 23–88 years, mean: 67.2 years) with Vancouver type B1 or C fractures. Seventeen patients (Group A; B1 fractures in 15 hips, C fractures in 2 hips) were treated with open reduction and internal fixation with locking compression plates (group A). The other 15 patients (Group B; B1 in 14 hips, C in 1 hip) were fixed by locking compression plating combined with cortical strut allografting (group B). The fracture healing rate, healing time, complications and function were compared between these two groups.ResultsThe mean follow-up time was 32.4 months (12 to 66), and the overall fracture union rate of the 32 patients was 96.9%. Group B had a higher fracture union rate than Group A, but the difference was not statistically significant. Group A had one case of nonunion of type B1 fracture and one case of malunion; the mean time to fracture healing was 5.3 months (3 to 9). In group B, all patients reached bony union without malunion, with a mean time of fracture healing of 5.1 months (3 to 8).ConclusionTreatment of Vancouver type B1 or C fractures by locking compression plating, with or without cortical strut allografting, resulted in similar union rates in these patients. This suggest that, the use of cortical strut allografting should be decided cautiously.

Medial malleolar osteotomy for the correction of tibiotalar varus deformity during total ankle arthroplasty: Results in 95 ankles

BackgroundThe importance of deformity correction before or during total ankle replacement (TAR) has been recognized for a long time. Our results of TAR, combined with medial malleolar lengthening osteotomy, for the reconstruction of osteoarthritic ankles with varus deformity are hereby reported. MethodsAll ankles in which a medial malleolar osteotomy was performed during implantation of an ankle prosthesis during the period 1998–2018 were filtered out of our database. Preoperative coronal talar alignment was evaluated by measuring the angle between the tibial shaft and talar dome on the weightbearing mortise ankle radiograph. Patient-reported outcomes were measured with the Foot and Ankle Outcome Score (FAOS) and the Foot and Ankle Ability Measure (FAAM). A Kaplan-Meier survival curve was constructed and the number of revisions per 100 observed component years was calculated for interprosthetic comparison. ResultsA total of 95 TARs were included, consisting of the Alpha Ankle Arthroplasty (n = 22); Buechel-Pappas (n = 14) and the Ceramic Coated Implant Evolution (n = 59) prostheses. The preoperative average talar angle in these ankles was 12.4 degrees varus. In 33% (31/95) corrective procedures, in addition to the medial malleolar osteotomy, were performed. A reoperation rate of 44% (42/95) was found, including 28 revisions (revision rate 29% (4% septic; 25% aseptic) at an average follow-up of 5.9 years, resulting in a survival of 0.69 for the total cohort at 10 years of follow-up.At an average follow-up of 6.6 years the average FAOS scores were: FAOSsymptoms 66, FAOSpain 73, FAOSfunction 78, FAOSsport 45 and FAOSquality of life 56 respectively. The FAAMadl score averaged 64. ConclusionThis is the largest cohort of TAR combined with medial malleolar osteotomy to date. A 29% revision rate at 5.9 years of average follow-up compares unfavorably with regular cohort studies and with most other results in varus-deformed ankles. Scores on the FAOS and FAAM are comparable to those obtained in regular cohorts with similar length of follow-up. TAR in varus-deformed ankles necessitating medial malleolar osteotomy has an even higher failure rate than regular TAR. Obtaining a stable prosthesis with a neutrally-aligned hindfoot at the end of the procedure is of paramount importance. Level of evidenceIV.

LONG-TERM THYROID DISORDERS IN CHILDREN RECEIVING ONCOLOGIC TREATMENT AND RADIOTHERAPY.

Childhood cancer survival has increased substantially over the past few decades. However, long-term side effects associated with cancer treatment have also risen. Especially thyroid gland disorders are common. The present retrospective cross-sectional study aimed to investigate risk factors of long-term TD in survivors of leukemia-lymphoma. The study included 44 acute lymphoblastic leukemia (ALL) and 26 Hodgkin lymphoma survivors (HL). Abnormal laboratory and pathological ultrasonographic findings of the thyroid gland were accepted as a thyroid disorder. The possible causes of thyroid disorders were investigated. Long-term thyroid disorder was found in 40% of the patients. This rate was higher in HL patients than in ALL (65% vs. 25%). Thyroid disorder was significantly more common in patients who received radiotherapy to the neck (57% vs. 17%). Radiotherapy to the neck area was the only significant determinant for thyroid disorders in the regression models [OR 33.17, 95% CI (2.76-398.9) p = 0.006]. However, HL remained significantly associated with TD in the logistic model performed using cancer type [OR 19.25, 95% CI (2.39-155.3) p = 0.006]. The study showed that radiotherapy applied to the neck was an essential risk factor for long-term TD in the average 6-year follow-up of cancer survivors. However, we recommend that childhood cancer survivors should be followed closely for a long time since long-term endocrine side effects were reported during longer than six years follow-up periods.

Improving and maintaining healthy lifestyles are associated with a lower risk of diabetes: A large cohort study.

AimsIt is well known that healthy lifestyles measured at one time‐point are inversely associated with diabetes risk. The impact of transitions in combined lifestyles in real settings remains unknown.Materials and MethodsThe trajectory patterns of combined lifestyles over three years were identified using group‐based trajectory modeling in 26,647 adults in Japan. Two types of indices (not having the unhealthy lifestyle [easy goal] and having healthiest lifestyles [challenging goal]) were developed using five lifestyle factors: smoking, alcohol consumption, exercise, sleep duration, and body weight control. This index was calculated using the yearly total score (0–5; higher score indicated healthier lifestyles). Diabetes was defined by high plasma glucose level, high hemoglobin A1c level, and self‐report.ResultsFive trajectory patterns were identified for each index and it was shown that healthier patterns are associated with a lower risk of type 2 diabetes during 6.6 years of average follow‐up. For example, with a challenging‐goal, compared with a persistently very unhealthy pattern, the adjusted hazard ratios (95% confidence intervals) were 0.65 (0.59, 0.73), 0.50 (0.39, 0.64), 0.43 (0.38, 0.48), and 0.33 (0.27, 0.41) for ‘persistently unhealthy’, ‘improved from unhealthy to moderately healthy’, ‘persistently moderately healthy’, and ‘persistently mostly healthy’ patterns, respectively.ConclusionsOur data reinforce the importance of improving and maintaining health‐related lifestyles to prevent diabetes.

Joint Line Obliquity Does Not Affect the Outcomes of Opening Wedge High Tibial Osteotomy at an Average 10-Year Follow-up

Background: A significant number of high tibial osteotomies (HTOs) result in an overcorrected tibia and subsequent excessive lateral joint line obliquity (JLO). The correlation between excessive JLO and poor outcomes is controversial. Purpose: To evaluate the prognostic factors (including a pathological postoperative JLO) related with the outcomes of opening wedge HTO at 10 years of follow-up. Study Design: Case series; Level of evidence, 4. Methods: All patients undergoing HTO between 2004 and 2017 for medial osteoarthritis and with a postoperative hip-knee-ankle angle between 176° and 185° were included. Clinical evaluation included Knee Society Score (KSS; knee score and function score), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and visual analog scale for pain. Several mechanical and anatomic angles were measured pre- and postoperatively on long-leg weightbearing radiographs. Abnormal JLO was defined as a Mikulicz–joint line angle (MJL) ≥94° or a mechanical medial proximal tibial angle (mMPTA) ≥95°. Regression analysis was performed to evaluate the association between independent variables and each outcome. A Kaplan-Meier cumulative survival analysis was performed. Results: A total of 92 knees in 76 patients were included. The mean age of the patients was 53.5 years (SD, 9.7 years), and the mean follow-up was 129.4 months (SD, 44.4 months). Increased JLO was associated with a significant preoperative varus deformity (small preoperative hip-knee-ankle angle), increased mechanical lateral distal femoral angle, increased joint line congruency angle, and increased knee-ankle joint angle. Male sex was associated with better WOMAC scores (P = .0277), and increased body mass index (BMI) was associated with inferior WOMAC scores (P = .0024). A good preoperative range of motion was associated with better knee score (P = .0399) and function score (P = .0366) on the KSS. An increased BMI was associated with inferior KSS function scores (P = .0317). MJL ≥94° and mMPTA ≥95° were not associated with inferior WOMAC or KSS outcomes. With indication to total knee arthroplasty as an endpoint, Kaplan-Meier analysis showed a survival rate of 98.7% at 5 years, 95.5% at 10 years, and 92.7% at 12 years. Conclusion: Increased lateral JLO (MJL ≥94° or mMPTA ≥95°) was not correlated with the clinical outcomes of opening wedge HTO at 10 years of follow-up.

Pilot Study to Assess the Change in Vaginal Dimensions Following Vaginal Brachytherapy (VBT)

Toxicities related to vaginal brachytherapy can be challenging to capture in patients with endometrial cancer treated with VBT HDR. In this pilot study, we sought to objectively measure the changes in vaginal length and caliber while capturing patient reported acute and chronic toxicities.63 patients with endometrial carcinoma treated with VBT 30 Gy in 3 fractions to the vaginal surface using Ir192 HDR from March 2015 through December 2018 were invited to return for a research visit. 18 patients with AJCC 8th pT1-T2 pNx-N1 cM0 endometrial carcinoma returned to clinic for measurement of vaginal length and diameter using VBT cylinders. Measurements were compared to vaginal length/diameter assessed during the first brachytherapy treatment. Vaginal and vulvar atrophy were assessed. Pain during insertion was measured on a scale of 0 to 10. The patients completed questionnaires regarding vaginal, rectal, urinary and dermatologic toxicities (using CTCAE v5.0). Toxicities were classified as acute if they occurred within the first 2 months after treatment, or chronic if they occurred 2 months after treatment. The mean differences in change between start of VBT and research visit for both vaginal length and diameter were calculated.Median age at time of diagnosis was 69 years (range 46-88). Tumor stage was pT1a 50% (n = 9), pT1b 38.9% (n = 7), and pT2 11.1% (n = 2). Of the 18, 13 (72.2%) had endometrioid tumors, 2 (11.1%) had serous, 2 (11.1%) had mixed, and 1 (5.6%) had clear cell. Median length of time from VBT start until research visit was 43.3 months. The median original vaginal length of the 18 women was 13.9 cm (range 11 - 18 cm). The median original cylinder size was 3.0 cm (range 2.5-3.0 cm). The mean decrease in vaginal length from VBT start to visit date was 1.4 cm, which was significantly different from zero (P = 0.0002). The mean decrease for the vaginal diameter was 0.03 cm which was not significantly different from zero (P = 0.6). On exam, 12 (66.6%) had grade 1-2 vaginal atrophy and 5 (27.8%) had grade 1 vulvar atrophy. Pain during cylinder placement was median of 1 (range 0-10); 77.8% had 0-2 out of 10 pain. Patient-reported acute grade 1-2 toxicities included dermatitis (n = 1), and cystitis (n = 1). There were no patient-reported grade 3-5 acute or chronic toxicities. Patient-reported chronic grade 1-2 toxicities included cystitis (n = 2), vaginal stenosis (n = 2), and diarrhea (n = 1).In our pilot study of 18 patients treated with VBT with 30 Gy in 3 fractions to the vaginal surface, we found a statistically significant average vaginal shortening after approximately 4.5 years of average follow-up. We observed no significant change in vaginal diameter. VBT was followed by infrequent patient-reported grade 1-2 acute or chronic toxicities. This report adds to the scarce literature of objective data on vaginal sequelae of VBT for endometrial carcinoma.K. Nieto: None. B. Levine: None. D.R. Brown: None. H.S. McGinnis: None. C.M. Lanier: None. K. Hines: None. K.M. Greven: None.

Analysis of Interwoven Nitinol Stenting for the Treatment of Critical Limb Ischemia: Outcomes From an Average 3-Year Follow-up Period.

We assessed the clinical outcomes of patients with critical limb-threatening ischemia (CLTI) who underwent interwoven nitinol stent (Supera) implantation for significant stenoses of the femoropopliteal segment. In this retrospective cohort study, 116 consecutive patients with CLTI who were treated with Supera stents between September 2015 and March 2020 were included in this analysis. Primary endpoint analysis was completed for amputation-free survival, target lesion revascularization (TLR), and mortality. After a mean follow-up time of 3.4 years, 21 (18%) patients had undergone amputations, 3 (2.6%) died, and, overall, the amputation-free survival rate was 81%. TLR occurred in 21 (18%) patients, resulting in the freedom from target lesion revascularization of 82%. The average Wagner score for all patients was 2.8 ± 1.1. A subgroup analysis of 57 patients revealed a median ulcer size of 3.0cm2 [1.65, 9.0], with complete healing for 45 patients by 20 months. The Wagner score of this subgroup decreased by an average of 3.4 ± .9 points. Supera stents can be used together with other endovascular therapies and are a safe and effective treatment modality for CLTI.

Rotator Cuff Repair and the Bovine Bioinductive Patch: Excellent Functional Outcomes and Satisfaction in Patients with Comorbidities (238)

Objectives:Structural failure of rotator cuff repair (RCR) has been reported to occur in 20-94% at one to two-year follow-up with 80% of these failures occurring within three months of surgical intervention. Poor functional outcomes as well as higher rates of retear have been reported in patients with compromised healing potential due to comorbidities such as diabetes, smoking, obesity, and hypercholesterolemia. Augmentation with growth factors and stem cells and/or biologically augmented patches has been shown to decrease re-tear rates. Biologically-augmented patches provide an environment that is conducive for cell and vessel migration. We investigated patient outcomes following RCR plus bovine bioinductive patch augmentation.Methods:A consecutive series of patients (2015-2018) that underwent RCR plus bovine bioinductive patch by a single surgeon were identified. Patients with diabetes, obesity, hypercholesterolemia, and smokers were included. Patients were excluded with revision rotator cuff repairs. Physical exam included shoulder ROM and manual muscle strength. Patients completed DASH, SF-12 physical and mental, VAS pain and patient satisfaction scores to assess postoperative functional outcomes. Paired sample t-tests were used to assess differences before and after surgery (p<0.05).Results:Sixteen patients (5 females, 62.3±14 years of age, BMI 32.3±13.7) that underwent arthroscopic RCR plus bovine bioinductive patch augmentation were included. Twelve patients had symptomatic 50-90% partial tears and four patients had full thickness tears. Average follow-up was 25.8±13.1 months. Mean shoulder flexion increased from 148.8°±17.5° to 164.7°±15.0° (p=0.0097), external rotation at 90° abduction increased from 67.8°±36.4° to 88.4°±3.5° (p=0.0316). No significant changes were seen in internal rotation behind the back (p=0.1750) or shoulder muscle strength measurements (all p>0.4471). Postoperative DASH score was 10.4±12.8, SF-12 physical score was 52.8±5, SF-12 mental score was 54.2±5.6, VAS pain score was 0.56±0.88, and patient satisfaction was 8.5±0.55. There were no complications or clinical failures at average 3-year follow-up. Patients returned to preoperative sports, including tennis, swimming, bowling, and weightlifting at an average of 21.9±14.3 weeks.Conclusions:RCR with bovine bioinductive patch augmentation is a good alternative treatment for patients with multiple comorbidities and partial and full thickness rotator cuff tears yielding high patient satisfaction, no loss of shoulder ROM or strength, good functional outcomes, and return to preoperative sports.

Conversion to Extension Contracture as a Means of Correction of Severe Flexion Contracture of the PIP Joint Using a Modified Dynamic External Fixator.

Background: This is a retrospective case series investigating the outcomes using a dynamic external fixator (DEF) for treatment on severe flexion contractures at the proximal interphalangeal (PIP) joint. Severe flexion contractures of the PIP joint occurring after multiple operations and neglected over a long period of time are difficult to treat. The recurrence of contracture, even after successful treatment, is inevitable in patients with severe cases. In this study, we defined the severity of PIP joint contracture based on the active range of motion (ROM), soft tissue condition, and duration of the contracture. We also illustrated the strategy, results, and complications of using a DEF with rubber bands in these severe cases. Methods: We studied 11 fingers of 10 patients with PIP joint contracture treated by DEF. These were fixed at a small arc and neglected for an average 4.1 years (range, 1-9 years). The temporal Kirshner wire (K-wire) fixation after achieving an extension via DEF was maintained for 9.1 weeks on average. We retrospectively reviewed the results of these patients with an average 2-year follow-up. Results: Our method yielded favorable results upon retrospective evaluation. The average active ROM of the affected PIP joint improved from 90/96° to 34/83° with a functional arc and good patient satisfaction. The elastic force induced by strong rubber bands was safe and effective. The first step of joint space widening was the key to obtaining a successful joint extension afterwards. Serious progression of osteoarthritis at the PIP joint and pin-site fracture were a complication in each one case. Conclusions: In this study, we evaluate the surgical strategy of using DEFs powered by elastic torque from rubber bands to treat severe cases of flexion contractures of fingers. We first created extension contracture intentionally, followed by promoting flexion movement during follow-up in this group of patients.

Non-steroidal Anti-inflammatory Drug Use and Risk of Age-Related Macular Degeneration in the California Teachers Study.

PurposeThe aim of this study was to examine whether use of regular aspirin and/or other non-steroidal anti-inflammatory drugs (NSAIDs) is associated with the development of age-related macular degeneration (AMD).MethodsIn the California Teachers Study cohort (N = 88,481) we identified diagnoses of AMD up to December 31, 2012 by linkage to statewide hospital discharge records. Aspirin, ibuprofen, other NSAIDs, and acetaminophen use and comprehensive risk factor information were collected via self-administered questionnaires at baseline in 1995–1996 and a follow-up questionnaire in 2005–2006. We employed Cox proportional hazard regression to model AMD risk.ResultsWe did not find any associations between AMD and frequency and duration of aspirin or ibuprofen use reported at baseline. In the subsample with more specific information on medication use, we observed a 20% decrease in risk of AMD among low-dose aspirin users (HR 0.81, 95% CI 0.70–0.95) and a 55% decrease among cyclooxygenase-2 (COX-2) inhibitor users (HR 0.45, 95% CI 0.26–0.78) during 6.3 years of average follow-up.ConclusionThe decrease in risk of intermediate- or late-stage AMD among women who reported regular use of low-dose aspirin or specific COX-2 inhibitors suggests a possible protective role for medications with COX-2 inhibitory properties or aspirin at doses used for cardiovascular disease prevention.