Facilitators and barriers to adolescent participation in a TB clinical trial.

The inclusion of adolescents in TB drug trials is essential for the development of safe, child-friendly regimens for the prevention and treatment of TB. TB Trials Consortium Study 31/AIDS Clinical Trials Group A5349 (S31/A5349) enrolled adolescents as young as 12 years old. We assessed investigator and coordinator described facilitators and barriers to adolescent recruitment, enrollment, and retention.Interviews were conducted with six investigators from sites that enrolled adolescent participants and six investigators from non-enrolling sites. Additionally, two focus groups were conducted with study coordinators from enrolling sites and two focus groups with non-enrolling sites. Discussions were transcribed, analyzed, summarized, and summaries were reviewed by Community Research Advisors Group members and research group representatives for content validity.Investigators and coordinators attributed the successful enrollment of adolescents to the establishment and cultivation of external partnerships, flexibility to accommodate adolescents' schedules, staff engagement, recruitment from multiple locations, dedicated recruitment staff working onsite to access potential participants, creation of youth-friendly environments, and effective communications. Non-enrolling sites were mainly hindered by regulations. Suggestions for improvement in future trials focused on study planning and site preparations.Proactive partnerships and collaboration with institutions serving adolescents helped identify and reduce barriers to their inclusion in this trial..

A novel needle-free method of lidocaine administration during standing castration of Holstein bulls.

The American Veterinary Medical Association recognizes castration to be important for both human and animal safety. Lidocaine delivered through-the-needle has been shown to be effective at reducing cortisol response to castration, but this method has drawbacks for both animals and caretakers. As such, a study was conducted to examine the potential benefits of lidocaine delivery using a pneumatic needle-free device immediately before standing bovine castration. Twelve Holstein bulls weighing 400.7 ± 39.5 kg (mean ± standard deviation) were enrolled. Bulls were allocated to receive a local anesthetic block of 2% lidocaine for surgical castration by traditional needle injection or by needle-free injection. Outcomes were collected out to 48 h postcastration. Outcome variables included plasma cortisol concentrations, visual analog scale scores for pain, medial canthus temperatures as measured using infrared thermography, pressure mat changes, and chute defense scores. A time effect was observed for cortisol, visual analog scale scores, infrared thermography temperatures, and some pressure mat outcomes. No statistically significant differences between lidocaine delivery methods were observed, but further research is needed to build upon this small dataset.

Isolated Talonavicular Arthrodesis as Treatment for Flexible Progressive Collapsing Foot Deformity: A Case Series.

Background: For the younger, more active patient with flexible symptomatic progressive collapsing foot deformity (PCFD), joint-sparing procedures may be preferred to preserve functional motion. Isolated talonavicular (TN) arthrodesis has been described for treatment of rigid and flexible PCFD for patients that are older and less active whose deformity is still correctable through the TN joint. The purpose of this study was to evaluate radiographic and clinical outcomes in patients with PCFD treated with isolated triplanar correction with a TN joint arthrodesis. Methods: Forty-nine patients (53 feet) with flexible PCFD underwent isolated TN arthrodesis. Weightbearing radiographs were performed pre- and postoperatively, and measurements included lateral talar-first metatarsal angle, calcaneal pitch, TN coverage angle, and the anteroposterior (AP) talar-first metatarsal angle. The Foot and Ankle Ability Measure (FAAM) and Veterans-Rand 12-Item Health Survey (VR-12) scores were also collected. Results: Thirty-five females and 14 males were evaluated with a mean age of 63 years, at an average follow-up of 41.3 months. Significant improvements were found radiographically. Lateral radiographs demonstrated improvements in lateral talar-first metatarsal angle from 25.2 degrees preoperatively to 9.5 degrees postoperatively (P < .001) and calcaneal pitch from 14.9 degrees preoperatively to 17.5 degrees postoperatively (P < .001). AP radiographs showed the TN coverage angle improving from 35.0 degrees to 4.9 degrees postoperatively (P < .001) and AP talar-first metatarsal angle improving from 17.3 degrees to 5.9 degrees postoperatively (P < .001). Clinical outcomes were improved in the FAAM pain score (48.6 to 39.2, P = .130), FAAM ADL score (53.8 to 69.2, P = .002), FAAM Sport score (29.5 to 40.7, P = .099), and the overall FAAM score (47.7 to 63.1, P = .006). Patient satisfaction with medical care was 85.2/100 postoperatively. Conclusion: Isolated TN arthrodesis is a viable surgical option for older, lower-demand patients with flexible PCFD. This study demonstrated significant improvements in radiographic alignment and FAAM scores. Comparative studies with other surgical procedures should be performed to determine which is the best technique for older, lower-demand patients with flexible PCFD. Level of Evidence: Level III, retrospective cohort study.

Outcomes of Conversion of Ankle Fusion to Total Ankle Arthroplasty.

With ankle replacements gaining popularity and documented good functional outcomes, there is an increasing number of patients inquiring about the possibility of converting an ankle fusion to a replacement. This could be due to pain, limited function, or increasing adjacent joint arthritis. There is an increasing body of evidence in the literature that a conversion to a replacement is possible and that the outcomes are positive. There are also absolute contradictions for a conversion. An absent fibula, pain of unknown origin, and recent infection fall in this category. Long-term follow-up is needed to see if conversions of ankle fusions to replacements have the same functional results and longevity as primary replacements.

Prospective Multicenter Study of Salto Talaris Ankle Arthroplasty With Minimum 4-Year Follow-Up.

BACKGROUND: Total ankle arthroplasty (TAA) continues to be investigated as a primary treatment for end-stage ankle arthritis. The objective of this study is to report mid- to long-term results of the Salto Talaris TAA using prospectively collected patient-reported outcomes and implant survival rates with 4- to 13-year follow-up. METHODS: This was a retrospective study of prospectively collected data from 2 multicenter cohort studies from 3 centers. Three hundred fourteen subjects who received a Salto Talaris TAA from 2005 to 2015 were included in the study. Follow-up ranged 4-13 years following index procedure. Outcomes included 36-Item Short Form Health Survey (SF-36) mental and physical component summary scores, pain scores, and adverse events including additional surgeries, revision, or removal of components. RESULTS: Significant improvements were seen in pain and physical function scores at 2-year follow-up and were generally maintained through most recent follow-up. The survival rate of the prosthesis was >95% (n = 30/32 at >10 years, n = 272/282 at 4.5-10 years). Thirteen patients (4.1%) underwent revision or removal of their prosthesis. Time to revision ranged from 2 months to 6.5 years following the index procedure. Twenty-two patients (7.0%) had additional surgery that did not involve revision or removal of components. CONCLUSION: Treatment of end-stage ankle arthritis with this implant provided patients with improved pain and functional outcome scores at mid- to long-term follow-up. The significant improvements reported at 2-4 years appeared to endure through the extended follow-up period. LEVEL OF EVIDENCE: Level III, retrospective cohort study.

Rationale and design of an implant procedure and pivotal study to evaluate safety and effectiveness of Medtronic's tibial neuromodulation device.

Percutaneous tibial neuromodulation is a medical guideline recommended therapy for treating symptoms of overactive bladder. Stimulation is delivered to the tibial nerve via a thin needle placed percutaneously for 30 min once a week for 12-weeks, and monthly thereafter. Studies have shown that this therapy can effectively relieve symptoms of overactive bladder; however, the frequent office visits present a barrier to patients and can impact therapy effectiveness. To mitigate the burden of frequent clinic visits, small implantable devices are being developed to deliver tibial neuromodulation. These devices are implanted during a single minimally invasive procedure and deliver stimulation intermittently, similar to percutaneous tibial neuromodulation. Here, we describe the implant procedure and design of a pivotal study evaluating the safety and effectiveness for an implantable tibial neuromodulation device. The Evaluation of Implantable Tibial Neuromodulation (TITAN 2) pivotal study is a prospective, multicenter, investigational device exemption study being conducted at up to 30 sites in the United States and enrolling subjects with symptoms of overactive bladder.

Outcomes of Surgically Treated Purely Ligamentous Stage II Lisfranc Injuries.

BACKGROUND: Low-energy stage II Lisfranc injuries are rare, and treatment can be operative or nonoperative based on a surgeon's assessment of midfoot stability. No previously published patient-reported outcome measures (PROMs) data for Lisfranc injuries isolates purely ligamentous stage II injuries. The purpose of this study was to analyze PROMs for patients who underwent operative management of stage II Lisfranc injuries. METHODS: Thirty-nine patients (39 feet) with confirmed Nunley-Vertullo stage II Lisfranc injuries between May 2012 and February 2022 were identified through a retrospective chart review. PROMs that were analyzed were the visual analog scale (VAS) pain scale, Veterans RAND 12-Item Health Survey (VR-12), Foot and Ankle Ability Measure (FAAM), and patient satisfaction. RESULTS: Thirty-two open reduction internal fixations (ORIFs) and 7 fusions were performed. The mean latest follow-up was 44.6 (range, 12-92) months. There were 2 complications (5%, 2/39) that required a revision procedure. Twenty-six patients (67%, 26/39) underwent secondary surgery to remove retained hardware. The mean time to hardware removal was 3.97 (range, 2.70-7.47) months. The overall mean patient satisfaction score with overall medical care including clinical visits and interactions with medical staff personnel was 93.6/100. All PROMs (VAS, VR-12, FAAM) demonstrated statistically significant improvement (P < .05) from preoperative (injury) values to latest follow-up postinjury values. CONCLUSION: Patients who were treated surgically with stage II purely ligamentous Lisfranc injuries via the methods used were found to mostly undergo hardware removal and have high levels of overall satisfaction with their process of medical care. LEVEL OF EVIDENCE: Level IV, retrospective case series.

Veterinarians' perspectives of pain, treatment, and diagnostics for bovine respiratory disease in preweaned dairy calves.

Background: Bovine Respiratory Disease (BRD) is a leading cause of morbidity and mortality in preweaned dairy calves. Early detection and therefore treatment are essential to minimize animal welfare concerns, particularly given that recent research also demonstrates that BRD is painful. Veterinarians are essential to ensuring calves with BRD receive appropriate treatment, but little to no research exists regarding veterinarians' perspectives about BRD detection and treatment in dairy calves. This is a critical step to determine education and outreach needs that can target BRD treatment to improve calf welfare. Thus, the objectives of the current study were to describe US veterinarians' current detection methods and treatment practices for BRD in preweaned dairy calves, understand veterinarians' rationale for treatment decisions, and identify gaps in knowledge regarding treatment and management of calf BRD. Methods: An online survey was sent to two veterinarian-focused list-serves and newsletter. Final responses (n = 47) were analyzed using qualitative and quantitative analyses. Results: On-farm necropsy was the diagnostic tool most considered "extremely important" (26, 55.3%). All veterinarians indicated that BRD was at least mildly painful. However, only 53% of veterinarians (n = 25) assess pain in preweaned calves with BRD in order to make treatment decisions. Furthermore, of the veterinarians that assessed pain, 40% (n = 10) reported that their knowledge of pain assessment and treatment was adequate, but most (n = 24) considered a calf's pain-level at least "moderately important" to make BRD treatment decisions. The most important ancillary therapy for antimicrobials were NSAIDs (21, 44.7%). The ancillary therapy most often considered "extremely important" for treating BRD was NSAIDs. Qualitative analysis identified the following as factors that influenced veterinarians' willingness to provide analgesia: the farm's willingness to administer drugs, clinical signs, perceived severity of pain, the need for anti-inflammatories, and the presence of fever and comorbidities. Discussion: This study included a small sample size and an extremely low response rate; results should therefore be interpreted with caution. Despite this limitation, important gaps in knowledge were identified, including pain assessment and consideration when making treatment decisions, and diagnostic tools. Addressing these needs in future research and outreach efforts could help ensure appropriate and timely treatment of calf BRD, including pain mitigation.

Characterizing the diagnostic sensitivity and specificity of pain biomarkers in cattle using receiver operating characteristic curves.

Biomarkers are used to assess pain and analgesic drug efficacy in livestock. However, often the diagnostic sensitivity and specificity of these biomarkers for different painful conditions over time have not been described. Receiver operating characteristic (ROC) curves are graphical plots that illustrate the diagnostic ability of a test as its discrimination threshold is varied. The objective of this analysis was to use area under the curve (AUC) values derived from ROC analysis to characterize the predictive value of potential pain biomarkers at specific time points following a painful stimulus. The biomarkers included in the analysis were plasma cortisol, salivary cortisol, hair cortisol, infrared thermography (IRT), mechanical nociceptive threshold (MNT), substance P, kinematic gait analysis, and a visual analog scale for pain. A total of 7,992 biomarker outcomes collected from 7 pain studies involving pain associated with castration, dehorning, lameness, and abdominal surgery were included in the analysis. Each study consisted of 3 treatments: uncontrolled pain (tissue damage), no pain (handled controls), and analgesic use (tissue damage, administered a nonsteroidal anti-inflammatory drug). Results comparing analgesic effects to uncontrolled pain consistently yielded AUC values >0.7 (95% confidence interval: 0.40 to 0.99) for plasma cortisol (time points: 1.5, 2, 3, 4, 6, and 8 h), hair cortisol (time point: 62 d), and IRT (time point: 72 h). Results comparing analgesic effects to uncontrolled pain consistently yielded AUC values <0.7 (95% confidence interval: 0.28 to 0.90) for salivary cortisol (6, 13, 20, 34, 48, and 62 d); MNT (6, 25, and 49 h); substance P (1, 2, 3, 4, 6, 8, 12, 18, 24, 48, 72, 96, 120, 144, 312, 480, 816, 1,152, and 1,488 h); kinematic gait analysis including area (8, 16, 48, 72, 96, and 120 h), force (8, 16, 24, 48, 72, 96, and 120 h), and pressure (8, 16, 24, 48, 72, 96, and 120 h); and a visual analog scale for pain (1, 2, 3, 4, 5, and 6 d). These results indicate that ROC analysis can be used to characterize the predictive value of pain biomarkers and provide new knowledge on the diagnostic accuracy of pain biomarkers within this data set. This analysis, using data from 7 studies, was a preliminary approach to identify biomarkers and collection time points that could inform additional analytical approaches or meta-analyses with larger sample sizes, which are needed to further validate these hypotheses and conclusions.

Determination of milk concentrations and pharmacokinetics of salicylic acid following acetylsalicylic acid (aspirin) administration in postpartum dairy cows.

The objectives of this descriptive study were to (1) describe the pharmacokinetics of salicylic acid (SA) in the milk and plasma of postpartum dairy cattle following oral administration of acetylsalicylic acid (ASA; aspirin), (2) to estimate a recommended milk withdrawal period for dairy cattle treated with ASA, and (3) to determine the effect of ASA administration on plasma prostaglandin E2 metabolite (PGEM) concentrations. Primiparous (n = 3) and multiparous (n = 7) postpartum Holstein dairy cows received 2 oral treatments with ASA at 200 mg/kg of body weight, 24 h apart. Concentrations of SA in plasma and milk from 0 h through 120 h after ASA administration were analyzed using ultra performance liquid chromatography triple quadrupole mass spectrometry and a milk withdrawal period was estimated using the United States Food and Drug Administration Milk Discard App in R. Two withdrawal periods were estimated: (1) a whole-herd treatment scenario with no dilution factor and (2) an individual animal treatment scenario with a bulk tank factor included in analysis. Plasma PGEM concentrations in samples from 0 h to 24 h after ASA administration were determined using a commercially available competitive ELISA. Milk SA concentrations were undetected in all cows by 48 h after the last ASA treatment. Secondary peaks were observed in plasma at 58 and 82 h after the last treatment and in milk at 87 h after the last treatment. In the absence of a tolerance for SA in milk, the estimated milk withdrawal periods were (1) 156 h for the whole-herd treatment scenario and (2) 120 h for the individual animal treatment scenario. Plasma PGEM concentrations were reduced compared with baseline for up to 12 h after ASA administration, with the greatest reduction observed at 2 h. Results from this study suggest that the current milk withhold recommendation for dairy cattle administered ASA may need revision to 120 h (5 d) and that ASA administration may mitigate postpartum inflammation through reduction in prostaglandin production for up to 12 h after treatment. Pharmacokinetic and milk withdrawal data from this study will inform future recommendations for extra-label use of aspirin in postpartum dairy cows. Further research is required to determine the basis for the secondary SA peaks and to elucidate the long-term effects of ASA administration on dairy cow health.

Takedown of Ankle Fusions and Conversion to Total Ankle Replacements.

BACKGROUND: With ankle replacements gaining credibility, there is a small subset of patients who might benefit from a conversion of an ankle fusion to a replacement. The objective of this study is to present clinical and radiographic results of patients who had their ankle fusion converted to total ankle arthroplasty (TAA). METHODS: Patients presented to the senior author with ongoing ankle pain following fusion or increasing pain after a period of relative comfort after an ankle fusion. Outcomes were evaluated preoperatively and postoperatively with the Veterans Rand Health Survey (VR-12), Ankle Osteoarthritis Scale (AOS), and visual analog scale (VAS) pain scale. A patient satisfaction survey was also distributed. RESULTS: All ankle fusion conversions between April 2010 and December 2019 were included. Fifty-one patients (30 females) with the mean age of 62.6 (range, 37-83) years were followed. Mean follow-up was 4.2±2.3 (range, 2-11.5) years. Two patients were lost to follow-up (1 is deceased). Pre- and postoperative mean patient-reported outcome scores were all significantly different between groups except VR-12 mental subscale scores. VR-12 physical scores improved from 28.7±8.9 preoperatively to 38.9±9.9 (P < .001) postoperatively; VR-12 mental score was stable. AOS pain and disability subscales similarly improved: 55.9±24.4 to 27.9±25.4 (P < .001) and 61.7±21.1 to 31.1±25.7 (P < .001), respectively. VAS pain improved from a mean of 64.5±27.3 to 29.4±27.7 (P < .001). There was no tibiotalar dorsiflexion or plantarflexion with the ankle fusion. Initial postoperative visit revealed that average dorsiflexion was 10.9±5.93 degrees and average plantarflexion was 14.1±5.22 degrees. At the latest follow-up, dorsiflexion improved significantly to 15.5±6.33 degrees (P < .001), with no significant improvement in plantarflexion (P = .980). CONCLUSION: In this single-surgeon longitudinal study of 51 patients with a painful, malaligned, or nonhealed ankle fusion treated with an ankle replacement, we found highly satisfactory functional outcomes at an average of 4.2 years. Continued long-term follow-up will reveal whether the longevity of these replacements is comparable to primary replacements.

Factors associated with mortality in patients with COVID-19 admitted to intensive care: a systematic review and meta-analysis.

Identification of high-risk patients admitted to intensive care with COVID-19 may inform management strategies. The objective of this meta-analysis was to determine factors associated with mortality among adults with COVID-19 admitted to intensive care by searching databases for studies published between 1 January 2020 and 6 December 2020. Observational studies of COVID-19 adults admitted to critical care were included. Studies of mixed cohorts and intensive care cohorts restricted to a specific patient sub-group were excluded. Dichotomous variables were reported with pooled OR and 95%CI, and continuous variables with pooled standardised mean difference (SMD) and 95%CI. Fifty-eight studies (44,305 patients) were included in the review. Increasing age (SMD 0.65, 95%CI 0.53-0.77); smoking (OR 1.40, 95%CI 1.03-1.90); hypertension (OR 1.54, 95%CI 1.29-1.85); diabetes (OR 1.41, 95%CI 1.22-1.63); cardiovascular disease (OR 1.91, 95%CI 1.52-2.38); respiratory disease (OR 1.75, 95%CI 1.33-2.31); renal disease (OR 2.39, 95%CI 1.68-3.40); and malignancy (OR 1.81, 95%CI 1.30-2.52) were associated with mortality. A higher sequential organ failure assessment score (SMD 0.86, 95%CI 0.63-1.10) and acute physiology and chronic health evaluation-2 score (SMD 0.89, 95%CI 0.65-1.13); a lower PaO2 :FI O2 (SMD -0.44, 95%CI -0.62 to -0.26) and the need for mechanical ventilation at admission (OR 2.53, 95%CI 1.90-3.37) were associated with mortality. Higher white cell counts (SMD 0.37, 95%CI 0.22-0.51); neutrophils (SMD 0.42, 95%CI 0.19-0.64); D-dimers (SMD 0.56, 95%CI 0.43-0.69); ferritin (SMD 0.32, 95%CI 0.19-0.45); lower platelet (SMD -0.22, 95%CI -0.35 to -0.10); and lymphocyte counts (SMD -0.37, 95%CI -0.54 to -0.19) were all associated with mortality. In conclusion, increasing age, pre-existing comorbidities, severity of illness based on validated scoring systems, and the host response to the disease were associated with mortality; while male sex and increasing BMI were not. These factors have prognostic relevance for patients admitted to intensive care with COVID-19.

Comparing 4-Year Changes in Patient-Reported Outcomes Following Ankle Arthroplasty and Arthrodesis.

BACKGROUND: The rate of total ankle arthroplasty (TAA) is increasing relative to ankle arthrodesis (AA) for patients seeking surgical treatment for end-stage ankle arthritis. Patients and providers would benefit from a more complete understanding of the rate of improvement, the average length of time to achieve maximal function and minimal pain, and whether there is a greater decline in function or an increase in pain over time following TAA compared with AA. The objectives of this study were to compare treatment changes in overall physical and mental function and ankle-specific function, as well as pain intensity at 48 months after TAA or AA in order to determine if the improvements are sustained. METHODS: This was a multisite prospective cohort study that included 517 participants (414 TAA and 103 AA) who presented for surgical treatment. Participants were compared 48 months after surgery using the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and Sports subscales (0 to 100 points), the Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) scores (0 to 100 points), and pain scores (0 to 10 points). RESULTS: Both groups achieved significant improvement in the 2 FAAM measures, the SF-36 PCS score, and all of the pain measures at 48 months after surgey (p < 0.001). Mean improvements from baseline in patients undergoing TAA for the FAAM Activities of Daily Living, FAAM Sports, and SF-36 scores were at least 9 points, 8 points, and 3.5 points, respectively, which were higher than in those undergoing AA. Mean improvements in worst and average pain were at least 0.9 point higher in patients undergoing TAA than in those undergoing AA at 12, 24, and 36 months. These differences were attenuated by 48 months. For both treatments, all improvements from baseline to 24 months had been maintained at 48 months. CONCLUSIONS: When both procedures are performed by the same group of surgeons, patients who undergo TAA or AA for end-stage ankle arthritis have significant improvement in overall function, ankle-specific function, and pain at 48 months after surgery, with better functional improvement in the TAA group. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Converting Ankle Arthrodesis to a Total Ankle Arthroplasty.

Several articles in the literature discuss the positive results of converting a painful ankle fusion to an ankle replacement. Our results confirm that in well-selected cases a conversion to a total ankle replacement is not only possible, but also significantly improves quality of life and reduces pain. The outcome of a total ankle replacement after an ankle fusion depends to a degree on the method of fusion. Less destructive fusion that is arthroscopic has better results than conventional transfibular open fusions. Absence of a fibula should be an absolute contraindication for a conversion.

Femoral Head Allografts for Talar Body Defects.

BACKGROUND: Large structural bone deficits after a failed ankle arthroplasty or avascular necrosis (AVN) of the talus present a complex reconstruction challenge. The aim of this study was to report the results of patients undergoing an ankle arthrodesis or tibiotalocalcaneal fusion using a femoral head allograft (FHA). METHODS: All ankle and tibiotalocalcaneal fusions using FHA between February 2006 and January 2019 were included. Forty-four patients (45 ankles) with a mean follow-up of 42.8 months were studied. Males accounted for 58.1% (25/43 patients). All patients had either failure of primary or revision total ankle arthroplasty (TAA) or AVN of the talus. Pre- and postoperative Veterans RAND Health Survey (VR-12), Foot and Ankle Ability Measure (FAAM), Ankle Osteoarthritis Scale (AOS) and visual analog scale (VAS) for pain scores were obtained. A patient satisfaction survey was distributed postoperatively and results were tabulated. RESULTS: Preoperatively to postoperatively, the VR-12 Mental score remained essentially unchanged (P = .752) and the VR-12 Physical score improved (P = .007); the FAAM Activities of Daily Living (ADL) and Sport scores improved (P < .001); the AOS Pain and Disability scores improved (P < .001); and the man VAS score improved (P < .001). The overall satisfaction rate was 78.6 on a 100-point scale. At an average of 18.7 weeks, 90.7% of the ankles were substantially fused. Five patients went on to nonunions and revision surgery. CONCLUSION: The use of FHA to treat talar defects was a viable option. In this complex patient population, the arthrodesis rate was high at 89% with very positive patient-reported outcome scores. LEVEL OF EVIDENCE: Level IV, case series.

Traditional Modified Broström vs Suture Tape Ligament Augmentation.

BACKGROUND: The modified Broström (MB) procedure has long been the mainstay for the treatment of chronic lateral ankle instability (CLAI). Recently, suture tape (ST) has emerged as augmentation for this repair. The clinical benefit of such augmentation has yet to be fully established. The purpose of this study was to determine if ST augmentation provides an advantage over the traditional MB. METHODS: Adult patients were identified for inclusion in the study based on indications for primary lateral ligament reconstruction for CLAI. The primary outcome measure was time to return to preinjury level of activity (RTPAL). Secondary outcome measures included complications, ability to participate in an accelerated rehabilitation protocol (ARP), patient-reported outcomes (PROs), and visual analog pain scale (VAS). A total of 119 patients with CLAI were enrolled and randomized to the MB (59 patients) or ST (60 patients) treatment arm. RESULTS: Average RTPAL was 17.5 weeks after MB and 13.3 weeks after ST (P < .001). At 26 weeks, 12.5% of patients in the MB group and 3.6% of patients in the ST group had not managed RTPAL (P = .14). The complication rate was 8.5% in the MB group vs 1.7% in the ST group (P = .12). Four patients in the MB group failed to complete the ARP vs 1 in the ST group (P = .144). CONCLUSION: Results from this multicenter, prospective, randomized trial suggest that ST augmentation allows for earlier RTPAL than MB alone. ST augmentation may support successful accelerated rehabilitation and did not result in increased complications or morbidity. LEVEL OF EVIDENCE: Level II, prospective comparative study.

Evaluation of a carbon dioxide laser scalpel for disbudding Holstein calves: A pilot study.

Cautery hot-iron disbudding is a painful routine husbandry practice performed on many dairy farms and calf rearing facilities. Refinements to eliminate or reduce the pain associated with disbudding are desired. Carbon dioxide (CO2) laser scalpels cut and ablate tissue using high-power light energy. The objective of this study was to test the utility of a CO2 laser scalpel in bovine disbudding and to compare healing and pain measures with those of cautery hot-iron disbudding. Twelve Holstein bull calves (6-39 d of age) were enrolled in the study. Calves were randomly assigned into groups that were disbudded with a CO2 laser scalpel (n = 6) or cautery hot iron (n = 6). Calves were sedated with xylazine for the procedure and were given oral meloxicam and a local anesthetic block for analgesia. Outcome measures were maximum surface temperature by infrared thermography, mechanical nociception threshold (MNT) tests, and digital images for wound healing. The infrared thermography and MNT measures were collected before disbudding and out to 72 h postprocedure. Images for wound healing were collected before disbudding and at 6, 24, and 72 h and 7, 14, 28, and 42 d postdisbudding. Overall maximum surface temperatures were not different between groups (35.3 ± 0.3°C vs. 36.0 ± 0.3°C for laser and hot iron, respectively). No differences in overall MNT measures were noted between the laser calves (2.28 ± 0.19) and the hot-iron calves (2.42 ± 0.19 kg of force). All 6 calves in the laser group were completely healed by d 42, whereas only 4 out of 6 hot-iron calves were fully healed. These results suggest that disbudding calves using a CO2 laser scalpel may be painful based on the outcomes measured. Further research that focuses on pain associated with time points beyond those used in this study and that performs the procedure in unsedated calves is needed to fully evaluate its utility.

Randomized controlled trial comparison of analgesic drugs for control of pain associated with induced lameness in lactating dairy cattle.

Both the economic loss and welfare implications of lameness affect the dairy industry. Currently no analgesic drugs are approved to alleviate lameness-associated pain in lactating dairy cattle in the United States. In this randomized controlled trial, 48 lactating Holsteins were enrolled to evaluate the effect of oral meloxicam and i.v. flunixin meglumine on induced lameness. Cows were allocated to 1 of 4 treatment groups (n = 12 per group): lameness and flunixin meglumine (LAME + FLU); lameness and meloxicam (LAME + MEL); lameness and placebo (LAME + PLBO); or sham induction and placebo (SHAM + PLBO). Six hours before treatment, arthritis-synovitis was induced in the distal interphalangeal joint with 20 mg of amphotericin B, whereas SHAM cows were given an intra-articular injection of an equal volume (4 mL) of isotonic saline. Cows in LAME + FLU received 2.2 mg/kg flunixin meglumine i.v. and whey protein placebo orally; LAME + MEL were administered 1 mg/kg meloxicam orally and 2 mL/45 kg sterile saline placebo i.v.; LAME + PLBO were administered 2 mL/45 kg sterile saline placebo i.v. and whey protein placebo orally; and SHAM + PLBO received 2 mL/45 kg sterile saline placebo i.v. and whey protein placebo orally. The initial treatment of MEL, FLU, or PLBO was identified as time 0 h and followed by a second dose 24 h later with data collection for 120 h. The methods used to assess analgesic efficacy were electronic pressure mat, visual lameness assessment, visual analog score, plasma cortisol concentration, plasma substance P concentration, mechanical nociception threshold, and infrared thermography imaging. Linear mixed effect modeling was the primary method of statistical analysis. Visual lameness scoring indicated a lower proportion of the FLU + LAME group was lame at the T2 h and T8 h time points in comparison to the positive controls, whereas MEL therapy resulted in a lower proportion of lame cows at the T8 h time point. Cortisol area under the effect curve was lower following FLU therapy compared with LAME + PBLO for the 0-2 h (LSM difference = 35.1 ng·h/mL, 95% CI: 6.8, 63.3 ng·h/mL), 2-8 h (LSM difference = 120.6 ng·h/mL, 95% CI: 77.2, 164.0 ng·h/mL), and 0-24 h (LSM difference = 226.0 ng·h/mL, 95% CI: 103.3, 348.8 ng·h/mL) time intervals. Following MEL therapy, cortisol area under the effect curve was lower than LAME + PLBO for both the 2 to 8 h (LSM difference = 93.6 ng·h/mL, 95% CI: 50.2, 137.0 ng·h/mL) and 0 to 24 h time intervals (LSM difference = 187.6 ng·h/mL, 95% CI: 64.9, 310.4 ng·h/mL). Analysis of data from other assessment modalities failed to discern biologically relevant differences between treatment groups. We conclude that meaningful differences were evident for visual lameness assessment and cortisol from MEL and FLU treatment versus the positive control. Further clinical research is needed toward development of a model that will create reproducible events that are more pronounced in severity and duration of lameness which can be validated as a substitute for naturally occurring lameness cases.