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Background: Prior studies have suggested preoperative patient-reported outcome scores could predict patients who would achieve a clinically meaningful improvement with hallux valgus surgery. Our goal was to determine bunionectomy-specific thresholds using Patient-Reported Outcomes Measurement Information System (PROMIS) values to predict patients who would or would not benefit from bunion surgery. Methods: PROMIS physical function (PF), pain interference (PI), and depression assessments were prospectively collected. Forty-two patients were included in the study. Using preoperative and final follow-up visit scores, minimally clinically important differences (MCID), receiver operating characteristic (ROC) curves, and area under the curve (AUC) analyses were performed to determine if preoperative PROMIS scores predicted achieving MCID with 95% specificity or failing to achieve an MCID with 95% sensitivity. Results: PROMIS PF demonstrated a significant AUC and likelihood ratio. The preoperative threshold score for failing to achieve MCID for PF was 49.6 with 95% sensitivity. The likelihood ratio was 0.14 (confidence interval, 0.02-0.94). The posttest probability of failure to achieve an MCID for PF was 94.1%. PI and depression AUCs were not significant, and thus thresholds were not determined. Conclusion: We identified a PF threshold of 49.6, which was nearly 1 standard deviation higher than previously published. If a patient is hoping to improve PF, a patient with a preoperative t score >49.6 may not benefit from surgery. This study also suggests the need for additional research to delineate procedure-specific thresholds. Level of Evidence: Level III, retrospective comparative series. [ABSTRACT FROM AUTHOR]

Background: A prospective, randomized, noninferiority clinical trial of synthetic cartilage implant hemiarthroplasty for hallux rigidus demonstrated functional outcomes and safety equivalent to first metatarsophalangeal (MTP) joint arthrodesis at 24 months. We prospectively assessed safety and efficacy outcomes for synthetic cartilage implant hemiarthroplasty at a minimum of 5 years. Methods: Of 135 eligible patients from the original trial, 112 (83.0%) were enrolled (mean age, 58.2 ± 8.8 years; 87 females). Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL), and FAAM Sports subscales were completed preoperatively and 2 and 5 years postoperatively. Great toe active dorsiflexion, weightbearing radiographs, secondary procedures, and safety parameters were also evaluated. Results: At 24 months, 14/152 (9.2%) patients had undergone implant removal and conversion to arthrodesis. In years 2 to 5, 9/119 (7.6%) patients underwent implant removal and conversion to arthrodesis. At mean 5.8 ± 0.7 (range, 4.4-8.0) years' follow-up, pain VAS, FAAM ADL, and FAAM Sports scores improved by 57.9 ± 18.6 points, 33.0 ± 17.6 points, and 47.9 ± 27.1 points, respectively, from baseline. Clinically significant changes in VAS pain, FAAM ADL, and FAAM Sports were reported by 103/106 (97.2%), 95/105 (90.5%), and 97/104 (93.3%) patients, respectively. Patient-reported outcomes at 24 months were maintained at 5.8 years in patients who were not revised. Active MTP joint peak dorsiflexion was maintained. Ninety-nine of 106 (93.4%) patients would have the procedure again. Conclusion: Clinical and safety outcomes for synthetic cartilage implant hemiarthroplasty observed at 2 years were maintained at 5.8 years. The implant remains a viable treatment option to decrease pain, improve function, and maintain motion for advanced hallux rigidus. Level of Evidence: Level IV, case series. [ABSTRACT FROM AUTHOR]

Background: The Numeric Pain Rating Scale (NPRS) is a popular method to assess pain. Recently, the Patient-Reported Outcomes Measurement Information System (PROMIS) has been suggested to be more accurate in measuring pain. This study aimed to compare NPRS and PROMIS Pain Interference (PI) scores in a population of foot and ankle patients to determine which method demonstrated a stronger correlation with preoperative and postoperative function, as measured by PROMIS Physical Function (PF). Methods: Prospective PROMIS PF and PI and NPRS data were obtained for 8 common elective foot and ankle surgical procedures. Data were collected preoperatively and postoperatively at a follow-up visit at least 6 months after surgery. Spearman correlation coefficients were calculated to determine the relationship among NPRS (0-10) and PROMIS domains (PI, PF) pre- and postoperatively. A total of 500 patients fit our inclusion criteria. Results: PROMIS PF demonstrated a stronger correlation to PROMIS PI in both the pre- and postoperative settings (preoperative: ρ = −0.66; postoperative: ρ = −0.69) compared with the NPRS (preoperative: ρ = −0.32; postoperative:ρ = −0.33). Similar results were found when data were grouped by Current Procedural Terminology (CPT) code. Conclusion: PROMIS PI was a superior tool to gauge a patient's preoperative level of pain and functional ability. This information may assist surgeons and patients in setting postoperative functional expectations and pain management. Level of Evidence: Level II, prognostic. [ABSTRACT FROM AUTHOR]

Background: Establishing score points that reflect meaningful change from the patient perspective is important for interpreting patient-reported outcomes. This study estimated the minimum clinically important difference (MCID) values of 2 Patient-Reported Outcomes Measurement Information System (PROMIS) instruments and the Foot and Ankle Ability Measure (FAAM) Sports subscale within a foot and ankle orthopedic population. Methods: Patients seen for foot and ankle conditions at an orthopedic clinic were administered the PROMIS Physical Function (PF) v1.2, the PROMIS Pain Interference (PI) v1.1, and the FAAM Sports at baseline and all follow-up visits. MCID estimation was conducted using anchor-based and distribution-based methods. Results: A total of 3069 patients, mean age of 51 years (range = 18-94), were included. The MCIDs for the PROMIS PF ranged from approximately 3 to 30 points (median = 11.3) depending on the methods being used. The MCIDs ranged from 3 to 25 points (median = 8.9) for the PROMIS PI, and from 9 to 77 points (median = 32.5) for the FAAM Sports. Conclusions: This study established a range of MCIDs in the PROMIS PF, PROMIS PI, and FAAM Sports indicating meaningful change in patient condition. MCID values were consistent across follow-up periods, but were different across methods. Values below the 25th percentile of MCIDs may be useful for low-risk clinical decisions. Midrange values (eg, near the median) should be used for high stakes decisions in clinical practice (ie, surgery referrals). The MCID values within the interquartile range should be utilized for most decision making. Level of Evidence: Level I, diagnostic study, testing of previously developed diagnostic measure on consecutive patients with reference standard applied. [ABSTRACT FROM AUTHOR]

Background: Investigating the responsiveness of an instrument is important in order to provide meaningful interpretation of clinical outcomes. This study examined the responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), the PROMIS Pain Interference (PI), and the Foot and Ankle Ability Measure (FAAM) Sports subscale in an orthopedic sample with foot and ankle ailments. Methods: Patients presenting to an orthopedic foot and ankle clinic during the years 2014–2017 responded to the PROMIS and FAAM instruments prior to their clinical appointments. The responsiveness of the PROMIS PF v1.2, PROMIS PI v1.1, and FAAM Sports were assessed using paired samples t test, effect size (ES), and standardized response mean (SRM) at 4 different follow-up points. A total of 785 patients with an average age of 52 years (SD = 17) were included. Results: The PROMIS PF had ESs of 0.95 to 1.22 across the 4 time points (3, >3, 6, and <6 months) and SRMs of 1.04 to 1.43. The PROMIS PI had ESs of 1.04 to 1.63 and SRMs of 1.17 to 1.23. For the FAAM Sports, the ESs were 1.25 to 1.31 and SRMs were 1.07 to 1.20. The ability to detect changes via paired samples t test provided mixed results. But in general, the patients with improvement had statistically significant improved scores, and the worsening patients had statistically significant worse scores. Conclusion: The PROMIS PF, PROMIS PI, and FAAM Sports were sensitive and responsive to changes in patient-reported health. Level of Evidence: Level II, prospective comparative study. [ABSTRACT FROM AUTHOR]

Background: The knee scooter is a commonly used mobility device in the setting of unilateral below-knee immobilization. The bent-knee posture has been shown to decrease venous flow in a seated position, but the knee scooter differs as the patient is weightbearing through the affected extremity. Our goal was to investigate the effects of knee scooter positioning on popliteal venous flow. Methods: Duplex ultrasonography was performed to obtain venous diameter and flow velocity of the popliteal vein on healthy subjects over the age of 18 without immobilization. Measurements were performed on the left knee of each subject while standing and with the same knee flexed on the knee scooter, by 2 physicians trained in ultrasound techniques. Mean velocity, peak velocity, vessel diameter, and volumetric flow rate were calculated and t tests were performed for each variable. A power analysis was performed, determining that 9 subjects would provide 80% power with an alpha of 0.05. A total of 13 subjects participated in the study. Mean age was 33 (range 20-56) years, with 6 females and 7 males. Results: Measurements of subjects while standing and on the knee scooter demonstrated a significant decrease in mean velocity (6.5 vs 3.2 cm/s, P < .01) and volumetric flow rate (227.8 vs 106.2 mL/min, P < .01) while subjects were using the scooter. Vessel diameter (0.82 vs 0.78 cm, P = .15) and peak velocities (19.8 vs 14.7 cm/s, P = .19) were not significantly different between standing and kneeling positions. Conclusion: Our findings demonstrated a statistically significant decrease in volumetric flow rate in subjects using a knee scooter device with a flexed knee. Although venous stasis is a known risk factor for DVT, flow rate thresholds for increased thrombus formation are not well defined. The duration of scooter use, or flexed knee positioning, may have some effect on the degree of stasis. This finding should caution orthopedists to consider the risk attributed to the knee scooter as part of their overall patient assessment. Level of Evidence: Level II, therapeutic, comparative study. [ABSTRACT FROM AUTHOR]

Background: We evaluated data from a clinical trial of first metatarsophalangeal joint (MTPJ1) implant hemiarthroplasty and arthrodesis to determine the association between patient factors and clinical outcomes. Methods: Patients ≥18 years with hallux rigidus grade 2, 3, or 4 were treated with synthetic cartilage implant MTPJ1 hemiarthroplasty or arthrodesis. Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) sports and activities of daily living (ADL) scores, and Short Form-36 Physical Function (SF-36 PF) subscore were obtained preoperatively, and at 2, 6, 12, 24, 52, and 104 weeks postoperatively. Final outcome data, great toe active dorsiflexion motion, secondary procedures, radiographs, and safety parameters were evaluated for 129 implant hemiarthroplasties and 47 arthrodeses. The composite primary endpoint criteria for clinical success included VAS pain reduction ≥30%, maintenance/improvement in function, no radiographic complications, and no secondary surgical intervention at 24 months. Predictor variables included hallux rigidus grade; gender; age; body mass index (BMI); symptom duration; prior MTPJ1 surgery; preoperative hallux valgus angle, range of motion (ROM), and pain. Two-sided Fisher exact test was used (P < .05). Results: Patient demographics and baseline outcome measures were similar. Success rates between implant MTPJ1 hemiarthroplasty and arthrodesis were similar (P > .05) when stratified by hallux rigidus grade, gender, age, BMI, symptom duration, prior MTPJ1 surgery status, and preoperative VAS pain, hallux valgus, and ROM. Conclusion: Synthetic cartilage implant hemiarthroplasty was appropriate for patients with grade 2, 3, or 4 hallux rigidus. Its results in those with associated mild hallux valgus (≤20 degrees) or substantial preoperative stiffness were equivalent to MTPJ1 fusion, irrespective of gender, age, BMI, hallux rigidus grade, preoperative pain or symptom duration. Level of Evidence: Level II, randomized clinical trial. [ABSTRACT FROM AUTHOR]

Background: Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. Methods: In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject’s outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (<15%). A total of 236 patients were initially enrolled; 17 patients withdrew prior to randomization, 17 patients withdrew after randomization, and 22 were nonrandomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups. Results: VAS pain scores decreased significantly in both the implant and arthrodesis groups from baseline at 12 and 24 months. Similarly, the FAAM sports and activity of daily living subscores improved significantly at 12 and 24 months in both groups. First MTP active dorsiflexion motion improvement was 6.2 degrees (27.3%) after implant placement and was maintained at 24 months. Subsequent secondary surgeries occurred in 17 (11.2%) implant patients (17 procedures) and 6 (12.0%) arthrodesis patients (7 procedures). Fourteen (9.2%) implants were removed and converted to arthrodesis, and 6 (12.0%) arthrodesis patients (7 procedures [14%]) had isolated screws or plate and screw removal. There were no cases of implant fragmentation, wear, or bone loss. When analyzing the ITT and mITT population for the primary composite outcome of VAS pain, function (FAAM sports), and safety, there was statistical equivalence between the implant and arthrodesis groups. Conclusion: A prospective, randomized (2:1), controlled, noninferiority clinical trial was performed to compare the safety and efficacy of a small synthetic cartilage bone implant to first MTP arthrodesis in patients with advanced-stage hallux rigidus. This study showed equivalent pain relief and functional outcomes. The synthetic implant was an excellent alternative to arthrodesis in patients who wished to maintain first MTP motion. The percentage of secondary surgical procedures was similar between groups. Less than 10% of the implant group required revision to arthrodesis at 2 years. Level of Evidence: Level I, prospective randomized study. [ABSTRACT FROM AUTHOR]

Background: Surgical site infection is routinely cited as the most common complication following orthopedic foot and ankle surgery. Our institution uses 4% chlorhexidine gluconate followed by 70% isopropyl alcohol to reduce skin bacterial loads prior to surgery. These solutions have potential synergistic qualities to prevent a postoperative infection. The purpose of this study was to determine if the order of these solutions has a significant effect on the residual bacterial pathogens load following operative site preparation for foot and ankle surgery, as evidenced by positive culture swabs. Methods: A total of 95 consecutive patients, undergoing surgery of the foot and ankle with a single surgeon, were prospectively randomized to 1 of 2 operative preparation groups: isopropyl alcohol (IPA) group, whose operative site preparation consisted of a 4% chlorhexidine application followed by alcohol rinse (49 patients), and chlorhexidine gluconate (CHG) group, which had 46 patients undergo operative site preparation using alcohol followed by chlorhexidine. A total of 4 aerobic culture specimens were obtained from the third web space of the operative foot on each patient: (1) prior to operative site preparation, (2) after the prep was completed, (3) after completion of the procedure, and (4) after the incision was closed. Each patient was then followed for 6 months postoperatively to monitor the operative site. Medical comorbidities were also analyzed. Results: The average time for IPA procedures was 52 minutes vs 54 for CHG (ns). There was no difference between groups with respect to diabetes, tobacco use, obesity, race, or immunosuppression. Both groups had 100% bacterial growth from specimens obtained prior to operative site preparation (P > .05). For all postpreparation swabs, 19.0% (28/147) of the IPA cultures were positive compared to 10.9% (15/138) from the CHG group cultures (P = .07). The amount of patients with positive culture results favored the CHG group at each collection point: 6.5% (3/46) versus 25% (12/49) after draping (P = .02); 15% (7/46) versus 33% (16/49) after completion of the surgery (P = .05); and 20% (9/46) versus 35% (17/49) after skin closure (P = .07). One operative site infection was seen in the first 30 days following surgery for each treatment group, each treated with oral antibiotics. No additional skin or wound complications were encountered during the 6-month study follow-up. Conclusion: Postoperative infection rates following foot and ankle orthopedic surgery was low. Both chlorhexidine and isopropyl alcohol solutions were effective methods in reducing operative site bacterial colonization when combined. In this study, applying isopropyl alcohol solution followed by the chlorhexidine solution was more effective in reducing positive bacterial cultures taken after operative site preparation. No difference in clinical wound infection rate was seen. Level of Evidence: Level I, prospective randomized study. [ABSTRACT FROM AUTHOR]

Background: Selecting optimal patient-reported outcome (PRO) instruments is critical to improving the quality of health care. The purpose of this study was to compare the reliability, responsiveness, and efficiency of three PRO measures: the Foot and Ankle Ability Measure-Activity of Daily Living subscale (FAAM_ADL), the Foot Function Index 5-point verbal rating scale (FFI-5pt), and the PROMIS Physical Function computerized adaptive test (PF CAT). Methods: Data were aggregated from 10 clinical sites in the AOFAS's National Orthopaedic Foot and Ankle Research (OFAR) Network from 311 patients who underwent elective surgery for a disorder of the foot or ankle. Patients were administered the FAAM_ADL, FFI-5pt, and PF CAT at their preoperative visit and at 6 months after surgery. Reliabilities were evaluated using a Rasch model. Responsiveness was calculated using paired samples t test and efficiency was recorded as number of seconds to complete the instrument. Results: Similar reliabilities were found for the three instruments. Item reliabilities for FAAM_ADL, FFI-5pt, and PF CAT were all .99. Pearson reliabilities for FAAM_ADL, FFI-5pt, and PF CAT were .95, .93, and .96, respectively. On average, patients completed the FAAM_ADL in 179 seconds, the FFI-5pt in 194 seconds, and the PF CAT in 44 seconds, (P < .001). The PF CAT and FAAM_ADL showed significant improvement (P = .01 and P = .001, respectively) in patients' physical function after treatment; the FFI-5pt did not show improvement. Conclusions: Overall, the PF CAT performed best in terms of reliability, responsiveness, and efficiency in this broad sample of foot and ankle patients. It can be a potential replacement for the conventional PRO measures, but further validation is needed in conjunction with the PROMIS Pain instruments. Level of Evidence: Level I, prospective comparative outcome study. [ABSTRACT FROM AUTHOR]