Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain.

Purpose: This multicenter, randomized, double-blinded, active sham-controlled pivotal study was designed to assess the efficacy and safety of high-frequency nerve block treatment for chronic post-amputation and phantom limb pain. Patients and Methods: QUEST enrolled 180 unilateral lower-limb amputees with severe post-amputation pain, 170 of whom were implanted with the Altius device, were randomized 1:1 to active-sham or treatment groups and reached the primary endpoint. Responders were those subjects who received ≥50% pain relief 30 min after treatment in ≥50% of their self-initiated treatment sessions within the 3-month randomized period. Differences between the active treatment and sham control groups as well as numerous secondary outcomes were determined. Results: At 30-min, (primary outcome), 24.7% of the treatment group were responders compared to 7.1% of the control group (p=0.002). At 120-minutes following treatment, responder rates were 46.8% in the Treatment group and 22.2% in the Control group (p=0.001). Improvement in Brief Pain Inventory interference score of 2.3 ± 0.29 was significantly greater in treatment group than the 1.3 ± 0.26-point change in the Control group (p = 0.01). Opioid usage, although not significantly different, trended towards a greater reduction in the treatment group than in the control group. The incidence of adverse events did not differ significantly between the treatment and control groups. Conclusion: The primary outcomes of the study were met, and the majority of Treatment patients experienced a substantial improvement in PAP (regardless of meeting the study definition of a responder). The significant in PAP was associated with significantly improved QOL metrics, and a trend towards reduced opioid utilization compared to Control. These data indicate that Altius treatment represents a significant therapeutic advancement for lower-limb amputees suffering from chronic PAP.

Electrodiagnostic evidence of suprascapular nerve recovery after decompression.

INTRODUCTION: The purpose of this study was to determine whether surgical arthroscopic decompression or ultrasound-guided aspiration of a paralabral cyst would result in suprascapular nerve recovery from axonal regeneration based on electrodiagnostic testing. METHODS: Nine patients with preoperative electromyography (EMG) evidence of suprascapular neuropathy due to paralabral cysts at the suprascapular or spinoglenoid notch were prospectively studied. Eight patients underwent arthroscopic surgical decompression, and 1 patient underwent ultrasound-guided aspiration. Postoperative EMG was performed in all patients to evaluate nerve regeneration. RESULTS: Three (33%) patients had cysts at the suprascapular notch, whereas 6 (67%) patients had cysts at the spinoglenoid notch. All patients showed complete electrophysiological recovery after decompression. DISCUSSION: Decompression of paralabral cysts at the suprascapular or spinoglenoid notch resulted in postoperative EMG evidence of nerve recovery. Long-term studies with a greater number of patients are required to elucidate time to recovery. Muscle Nerve 59:247-249, 2019.

Resident Accuracy of Musculoskeletal Palpation With Ultrasound Verification.

OBJECTIVES: The purpose of this observational study was to determine the accuracy of musculoskeletal palpation of the medial joint line of the knee, medial patellar tendon, and posterior tibialis tendon verified by ultrasound imaging among physical medicine and rehabilitation residents. METHODS: Eighteen physical medicine and rehabilitation resident physicians at a single specialized institution were asked to identify the medial joint line of the knee, medial patellar tendon, and posterior tibialis tendon on 2 separate standardized patient models during a single data collection. They were asked to place a paper clip flat on the surface of the skin parallel to the specified anatomic structure. A high-frequency linear array transducer was used to identify whether the paper clip was correctly placed over the structures and to measure the distance from the intended structure. RESULTS: The accuracy rates for palpation of the medial joint line, medial patellar tendon, and posterior tibialis tendon in both models were 14%, 36%, and 28%, respectively, for all levels of residents. Accuracy rates for all of the structures by level of education were 19%, 29%, and 31% for postgraduate years 2, 3, and 4. Median confidence scores were 3.75, 3.5, and 2 for the medial joint line, medial patellar tendon, and posterior tibialis tendon. CONCLUSIONS: This study highlights the level of inaccuracy of musculoskeletal palpation skills and draws further attention to an area of much-needed improvement in our musculoskeletal residency training programs. Ultrasound imaging is an effective noninvasive method for providing swift feedback to medical students and residents and thereby reduce the instances of inaccurate musculoskeletal palpation.

Systematic Review of the Efficacy of Particulate Versus Nonparticulate Corticosteroids in Epidural Injections.

OBJECTIVE: To systematically analyze published studies in regard to the comparative efficacy of particulate versus nonparticulate corticosteroids for cervical and lumbosacral epidural steroid injections (ESI) in reducing pain and improving function. TYPE: Systematic review. LITERATURE SURVEY: MEDLINE (Ovid), EMBASE, and Cochrane databases were searched from the period of 1950 to December 2015. METHODOLOGY: Criteria for inclusion in this review were (1) randomized controlled trials and (2) retrospective studies that compared particulate versus nonparticulate medication in fluoroscopically guided injections via a transforaminal (TF) or interlaminar (IL) approach. Each study was assigned a level of evidence (I-V) based on criteria for therapeutic studies. A grade of recommendation (A, B, C, or I) was assigned to each statement. Categorical analysis of the data was reported when available, with success defined by the minimal clinically important difference for appendicular radicular pain-a reduction of at least 2 on the visual analog scale. When data were available, additional categorical analysis included the proportion of individuals with a reduction in pain of at least 50%, 70%, or 75%. Follow-up was included at all reported intervals from 2 weeks to 6 months. SYNTHESIS: Three cervical ESI and 6 lumbar ESI studies were found to be suitable for review. Of the 3 cervical ESI studies, 2 were retrospective studies with grade III level of evidence and 1 was a randomized controlled trial with grade II evidence. Of 4 lumbar ESI studies that used a TF approach, the 2 randomized double-blinded controlled trials were grade I evidence and 2 retrospective studies were grade II and III level of evidence. One randomized controlled trial using the lumbar IL approach was level II evidence. One retrospective cohort study using the lumbar TF, IL and caudal approach was level III evidence. CONCLUSIONS: There is no statistically significant difference in terms of pain reduction or improved functional outcome between particulate and nonparticulate preparations in cervical ESI and, therefore, the authors recommend using nonparticulate steroid when performing cervical TFESI (Grade of Recommendation: B). In patients with lumbar radiculopathy due to stenosis or disk herniation, TFESI using particulate versus non-particulate is equivocal in reducing pain (Grade of Recommendation: B) and improving function (Grade of Recommendation: C) and therefore the authors recommend the use of nonparticulate steroids for lumbar TFESI in patients with lumbar radicular pain (Grade of Recommendation: B). There is insufficient information to make a recommendation of one steroid preparation over the other in lumbar ILESI (Grade of Recommendation: I). Given the lack of strong data favoring the efficacy of one steroid preparation over the other, and the potential risk of catastrophic complications, all of which have been reported with particulate steroids, nonparticulate steroids should be considered as first line agents when performing ESIs. LEVEL OF EVIDENCE: III.

Treatment of postherpetic neuralgia using a thoracic transforaminal epidural steroid injection.

A 64-year-old male patient with a history of herpes zoster exposure presented with severe, constant, burning pain in the left T10 dermatome consistent with postherpetic neuralgia. Previous treatment included oral and topical medications as well as an intercostal nerve block; however, these treatment options did not provide significant relief. The patient was treated with a single-level T10 thoracic transforaminal epidural steroid injection for refractory postherpetic neuralgia. He reported complete resolution of his symptoms at 2- and 12-week follow-ups. This case illustrates transforaminal epidural steroid injections may be a successful treatment option for postherpetic neuralgia.

Intravenous versus oral outpatient antibiotic therapy for pediatric acute osteomyelitis.

The optimal route (oral versus intravenous) of antibiotic administration for pediatric acute osteomyelitis is not well established. Seventy-eight children from our university hospital and 17 children at our county hospital were treated for acute osteomyelitis. The rates of intravenous antibiotics upon discharge were 95% versus 65% (P=0.002), respectively. The recurrence rate and line complication rates were 10% and 24% at the university hospital, compared to 0% (P=0.34) and 6% (P=0.29) at the county hospital. Based on this data, a prospective comparison between intravenous and early oral antibiotic therapy for pediatric acute osteomyelitis is recommended.

Predictors of bone loss in revision total knee arthroplasty.

Revision total knee arthroplasty (RTKA) requires preoperative planning to enable the reconstruction of bony deficiencies. The objective of this project was to identify predictors of bone loss management at RTKA based on the preoperative failure mode and patient demographics known preoperatively. We retrospectively reviewed 245 consecutive RTKA procedures in which the same revision knee system was utilized. Patient demographic and treatment data were recorded, and locations of bone loss were identified based on the reconstructive management. We identified significant predictors for use of femoral augments at all four positions. Several predictors significantly predisposed to use of a thick (>19 mm) polyethylene; however, no predictors of tibial augments were significant. Although the reconstruction of bone loss is primarily based on the intraoperative assessment, these findings may provide additional information to help the surgeon prepare for difficult revision procedures.

Minced skin for tissue engineering of epithelialized subcutaneous tunnels.

We used minced, autologous skin for neoepithelialization of surgically created subcutaneous tunnels in a large animal model. Partial-thickness skin grafts were harvested from the back region of five 50-60 kg Yorkshire pigs. The skin was minced to 0.8 x 0.8 x 0.3 mm particles. Silicone-latex tubes were covered with fibrin, rolled in minced skin, and placed in subcutaneous tunnels created in the abdominal area. For comparison, single cell suspensions of keratinocytes and fibroblasts in fibrin or fibrin only were transplanted on tubes. Tunnels were extracted after 14, 21, and 28 days for microscopic evaluation. All tubes transplanted with minced skin particles showed neoepithelialization. The epithelium was stratified and differentiated after 2 weeks in vivo, and the stratum corneum was directed toward the implanted tube. No epithelium formed from tubes transplanted with single cell suspensions, and only sparse keratinocytes could be detected by serial sectioning and immunostaining on day 14, but not later. No epithelial lining was found in tunnels with fibrin-only-coated tubes. Epithelial cysts could be found the first 2 weeks after transplantation in the minced skin group but not later. In conclusion, a minced skin technique could serve as a potential source for tissue engineering of tubular conduits for reconstructive purposes of the urethra and for cutaneous stomas for bladder catheterization, or intestinal irrigations. The method would have the advantage of being simple and expeditious and not requiring in vitro culturing.

Measuring the report card: the validity of pay-for-performance metrics in orthopedic surgery.

To assess the validity of performance measures used in a nationwide pay-for-performance (P4P) project on hip and knee replacement, we analyzed hospital performance data from a Medicare P4P initiative and compared them to publicly available outcomes data. Overall, the ability to measure hospital quality was poor. A hospital's ranking on the composite score was primarily determined by process measures. A higher composite quality score was not associated with lower rates of complications or mortality. The current Medicare P4P quality measure has limited validity because of poor discrimination, lack of measure balance, and lack of correlation with important clinical outcomes.

Hospital characteristics associated with success in a pay-for-performance program in orthopaedic surgery.

BACKGROUND: Pay-for-performance programs are designed to link payments to clinical outcomes. We investigated the characteristics of hospitals in the United States, such as size and volume, that were associated with the receipt of a clinical performance bonus in a nationwide pay-for-performance program involving hip and knee replacement. METHODS: We obtained hospital-level outcomes data from a nationwide pay-for-performance demonstration project on hip and knee replacement. We obtained data on the hospital's size, procedure volume, and case-mix index as well as whether it was a teaching hospital and then performed a multivariate analysis to determine which factors were associated with the receipt of a performance bonus. RESULTS: Hospital size and revenue were not associated with the receipt of a performance bonus. Top-performance hospitals tended to be those specialized in orthopaedics (p < 0.002). Multivariate analysis revealed that high-performance hospitals tended to perform a high volume of hip and knee replacements (p < 0.008), to be teaching hospitals (p < 0.037), and to be located in the Midwestern United States (p < 0.001). CONCLUSIONS: Teaching hospitals that perform a high volume of hip and knee replacements will tend to succeed should pay-for-performance programs be enacted nationwide.

Routine use of wound vacuum-assisted closure does not allow coverage delay for open tibia fractures.

BACKGROUND: Prevention of infection is a paramount concern after open fracture of the tibia. Previous studies have shown that delay in soft-tissue coverage may raise infection rates. Use of vacuum-assisted closure devices in open fracture wounds has become common. The authors analyzed whether use of the vacuum-assisted closure sponge can allow delay of flap coverage for open tibia fractures without an increase in infection rate. METHODS: The authors identified 38 patients with Gustilo grade IIIB open fractures from their trauma registry with a minimum 1-year follow-up. From the medical record, the authors collected information on the time from injury to definitive wound coverage, type of fixation, type of coverage, and demographics. Infected patients were defined as patients that required surgical debridement after coverage with positive cultures. RESULTS: Patients who underwent definitive coverage within 7 days had a significantly decreased rate of infection (12.5 percent) compared with patients who had coverage at 7 days or more after injury (57 percent) (p < 0.008). The overall infection rate was 36 percent with routine use of the vacuum-assisted closure sponge. Patients who developed infection had a greater mean time to coverage than patients who did not develop infection (8.9 days versus 4.8 days; p < 0.029). CONCLUSIONS: Routine use of vacuum-assisted closure with open tibia fractures is safe and provides a good primary dressing over open wounds. For Gustilo grade IIIB tibia fractures, vacuum-assisted closure therapy does not allow delay of soft-tissue coverage past 7 days without a concomitant elevation in infection rates.

Regulation of neuron-specific alternative splicing of neurofibromatosis type 1 pre-mRNA.

Neurofibromatosis type 1 (NF1) is one of the most common heritable autosomal dominant disorders. Alternative splicing modulates the function of neurofibromin, the NF1 gene product, by inserting the in-frame exon 23a into the region of NF1 mRNA that encodes the GTPase-activating protein-related domain. This insertion, which is predominantly skipped in neurons, reduces the ability of neurofibromin to regulate Ras by 10-fold. Here, we report that the neuron-specific Hu proteins control the production of the short protein isoform by suppressing inclusion of NF1 exon 23a, while TIA-1/TIAR proteins promote inclusion of this exon. We identify two binding sites for Hu proteins, located upstream and downstream of the regulated exon, and provide biochemical evidence that Hu proteins specifically block exon definition by preventing binding of essential splicing factors. In vitro analyses using nuclear extracts show that at the downstream site, Hu proteins prevent binding of U1 and U6 snRNPs to the 5' splice site, while TIAR increases binding. Hu proteins also decrease U2AF binding at the 3' splice site located upstream of exon 23a. In addition to providing the first mechanistic insight into tissue-specific control of NF1 splicing, these studies establish a novel strategy whereby Hu proteins regulate RNA processing.

A randomized prospective study of music therapy for reducing anxiety during cast room procedures.

BACKGROUND: Cast room procedures, such as cast application and removal, pin removal, and suture removal can cause significant anxiety in young children. The use of music therapy in the cast room to decrease anxiety has not been previously reported. METHODS: We performed a randomized, prospective study of soft lullaby music compared with no music in 69 children 10 years or younger undergoing cast room procedures. Heart rates (beats per minute) were recorded in the waiting room and cast room using a pulse oximeter. RESULTS: A total of 28 children were randomized to music and 41 children to no music. The mean rise in heart rate between the waiting room and entering the cast room was -2.7 beats/min in the music group and 4.7 beats/min in the no music group (P = 0.001). The mean difference in heart rate between the waiting room and during the procedure was 15.3 beats/min in the music group and 22.5 beats/min in the no music group (P = 0.05). There were 7 patients in the no music group with heart rate increases of greater than 40 beats/min. No patient in the music group had an increase of this magnitude. CONCLUSIONS: Playing soft music in the cast room is a simple and inexpensive option for decreasing anxiety in young children during cast room procedures. LEVEL OF EVIDENCE: Randomized Clinical Trial, Level II.