Targeted Muscle Reinnervation Improves Residual Limb Pain, Phantom Limb Pain, and Limb Function: A Prospective Study of 33 Major Limb Amputees.

BACKGROUND: Targeted muscle reinnervation is an emerging surgical technique to treat neuroma pain whereby sensory and mixed motor nerves are transferred to nearby redundant motor nerve branches. In a recent randomized controlled trial, targeted muscle reinnervation was recently shown to reduce postamputation pain relative to conventional neuroma excision and muscle burying. QUESTIONS/PURPOSES: (1) Does targeted muscle reinnervation improve residual limb pain and phantom limb pain in the period before surgery to 1 year after surgery? (2) Does targeted muscle reinnervation improve Patient-reported Outcome Measurement System (PROMIS) pain intensity and pain interference scores at 1 year after surgery? (3) After 1 year, does targeted muscle reinnervation improve functional outcome scores (Orthotics Prosthetics User Survey [OPUS] with Rasch conversion and Neuro-Quality of Life [Neuro-QOL])? METHODS: Data on patients who were ineligible for randomization or declined to be randomized and underwent targeted muscle reinnervation for pain were gathered for the present analysis. Data were collected prospectively from 2013 to 2017. Forty-three patients were enrolled in the study, 10 of whom lacked 1-year follow-up, leaving 33 patients for analysis. The primary outcomes measured were the difference in residual limb and phantom limb pain before and 1 year after surgery, assessed by an 11-point numerical rating scale (NRS). Secondary outcomes were change in PROMIS pain measures and change in limb function, assessed by the OPUS Rasch for upper limbs and Neuro-QOL for lower limbs before and 1 year after surgery. RESULTS: By 1 year after targeted muscle reinnervation, NRS scores for residual limb pain from 6.4 ± 2.6 to 3.6 ± 2.2 (mean difference -2.7 [95% CI -4.2 to -1.3]; p < 0.001) and phantom limb pain decreased from 6.0 ± 3.1 to 3.6 ± 2.9 (mean difference -2.4 [95% CI -3.8 to -0.9]; p < 0.001). PROMIS pain intensity and pain interference scores improved with respect to residual limb and phantom limb pain (residual limb pain intensity: 53.4 ± 9.7 to 44.4 ± 7.9, mean difference -9.0 [95% CI -14.0 to -4.0]; residual limb pain interference: 60.4 ± 9.3 to 51.7 ± 8.2, mean difference -8.7 [95% CI -13.1 to -4.4]; phantom limb pain intensity: 49.3 ± 10.4 to 43.2 ± 9.3, mean difference -6.1 [95% CI -11.3 to -0.9]; phantom limb pain interference: 57.7 ± 10.4 to 50.8 ± 9.8, mean difference -6.9 [95% CI -12.1 to -1.7]; p ≤ 0.012 for all comparisons). On functional assessment, OPUS Rasch scores improved from 53.7 ± 3.4 to 56.4 ± 3.7 (mean difference +2.7 [95% CI 2.3 to 3.2]; p < 0.001) and Neuro-QOL scores improved from 32.9 ± 1.5 to 35.2 ± 1.6 (mean difference +2.3 [95% CI 1.8 to 2.9]; p < 0.001). CONCLUSIONS: Targeted muscle reinnervation demonstrates improvement in residual limb and phantom limb pain parameters in major limb amputees. It should be considered as a first-line surgical treatment option for chronic amputation-related pain in patients with major limb amputations. Additional investigation into the effect on function and quality of life should be performed. LEVEL OF EVIDENCE: Level IV, therapeutic study.

Targeted Muscle Reinnervation Treats Neuroma and Phantom Pain in Major Limb Amputees: A Randomized Clinical Trial.

OBJECTIVE: To compare targeted muscle reinnervation (TMR) to "standard treatment" of neuroma excision and burying into muscle for postamputation pain. SUMMARY BACKGROUND DATA: To date, no intervention is consistently effective for neuroma-related residual limb or phantom limb pain (PLP). TMR is a nerve transfer procedure developed for prosthesis control, incidentally found to improve postamputation pain. METHODS: A prospective, randomized clinical trial was conducted. 28 amputees with chronic pain were assigned to standard treatment or TMR. Primary outcome was change between pre- and postoperative numerical rating scale (NRS, 0-10) pain scores for residual limb pain and PLP at 1 year. Secondary outcomes included NRS for all patients at final follow-up, PROMIS pain scales, neuroma size, and patient function. RESULTS: In intention-to-treat analysis, changes in PLP scores at 1 year were 3.2 versus -0.2 (difference 3.4, adjusted confidence interval (aCI) -0.1 to 6.9, adjusted P = 0.06) for TMR and standard treatment, respectively. Changes in residual limb pain scores were 2.9 versus 0.9 (difference 1.9, aCI -0.5 to 4.4, P = 0.15). In longitudinal mixed model analysis, difference in change scores for PLP was significantly greater in the TMR group compared with standard treatment [mean (aCI) = 3.5 (0.6, 6.3), P = 0.03]. Reduction in residual limb pain was favorable for TMR (P = 0.10). At longest follow-up, including 3 crossover patients, results favored TMR over standard treatment. CONCLUSIONS: In this first surgical RCT for the treatment of postamputation pain in major limb amputees, TMR improved PLP and trended toward improved residual limb pain compared with conventional neurectomy. TRIAL REGISTRATION: NCT02205385 at ClinicalTrials.gov.

Locked Lateral Plating Versus Retrograde Nailing for Distal Femur Fractures: A Multicenter Randomized Trial.

OBJECTIVES: The 2 main forms of treatment for distal femur fractures are locked lateral plating and retrograde nailing. The goal of this trial was to determine whether there are significant differences in outcomes between these forms of treatment. DESIGN: Multicenter randomized controlled trial. SETTING: Twenty academic trauma centers. PATIENTS/PARTICIPANTS: One hundred sixty patients with distal femur fractures were enrolled. One hundred twenty-six patients were followed 12 months. Patients were randomized to plating in 62 cases and intramedullary nailing in 64 cases. INTERVENTION: Lateral locked plating or retrograde intramedullary nailing. MAIN OUTCOME MEASUREMENTS: Functional scoring including Short Musculoskeletal Functional Assessment, bother index, EQ Health, and EQ Index. Secondary measures included alignment, operative time, range of motion, union rate, walking ability, ability to manage stairs, and number and type of adverse events. RESULTS: Functional testing showed no difference between the groups. Both groups were still significantly affected by their fracture 12 months after injury. There was more coronal plane valgus in the plating group, which approached statistical significance. Range of motion, walking ability, and ability to manage stairs were similar between the groups. Rate and type of adverse events were not statistically different between the groups. CONCLUSIONS: Both lateral locked plating and retrograde intramedullary nailing are reasonable surgical options for these fractures. Patients continue to improve over the course of the year after injury but remain impaired 1 year postoperatively. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Comparing Temporospatial Performance During Brisk and Self-Paced Walking by Men With Osteomyoplastic Transfemoral Amputation and Controls Using Pressure and Muscle Activation Peak Times.

Background: The aim of osteomyoplastic transfemoral amputation (OTFA) is to produce sustained, robust prosthetic gait performance by residuum reconstructing. A better understanding of residuum-socket interface pressures (RSI) and residuum muscle activation should uniquely reveal gait stability to better inform long-term rehabilitation goals. Objectives: The objectives of this study are to characterize RSI pressures and residuum muscle activation in men with OTFA while walking at two speeds and compare temporospatial muscle activation with intact controls. Methods: In this study, we observed and compared healthy men with OTFA and controls during 2-min gait trials at brisk and self-paced speeds, two visits, and 1 year apart. RSI pressures and hip adductors, hamstrings, and quadriceps activation were recorded for those with OTFA. OTFA temporospatial muscle activation patterns were compared with the controls. Within the extracted strides, heel-strike and toe-off events and EMG activation peak times were characterized and compared. Peak times for pressure and EMG activity were examined in individual muscles and antagonist muscles of residual and intact limbs. Results: Six men with OTFA exhibited adductor, hamstring, and quadriceps co-contraction within intact and residual limbs, regardless of walking speed or trial. Co-contraction within their intact limb occurred throughout the gait cycle. Within the residuum, co-contraction occurred during weight transference. The 75% most likely RSI peaks occurred during stance. EMG peaks were 75% most likely to occur during early stance, terminal stance-initial swing, and terminal swing. Conclusion: Participants with OTFA demonstrated adductors-hamstrings-quadriceps co-contraction in the intact thigh and residuum with corresponding RSI pressure increase, primarily during transitions between stance and swing, indicating gait instability, demonstrating the need to explicitly address these deficits continuously in rehabilitation and wellness settings.

Benchmarking Residual Limb Pain and Phantom Limb Pain in Amputees through a Patient-reported Outcomes Survey.

More than 75% of major limb amputees experience chronic pain; however, data on severity and experience of pain are inconsistent. Without a benchmark using quantitative patient-reported outcomes, it is difficult to critically assess the efficacy of novel treatment strategies. Our primary objective is to report quantitative pain parameters for a large sample of amputees using the validated Patient-reported Outcomes Measurement System (PROMIS). Secondarily, we hypothesize that certain patient factors will be associated with worse pain. METHODS: PROMIS and Numerical Rating Scales for residual limb pain (RLP) and phantom limb pain (PLP) were obtained from a cross-sectional survey of upper and lower extremity amputees recruited throughout North America via amputee clinics and websites. Demographics (gender, age, race, and education) and clinical information (cause, amputation level, and time since amputation) were collected. Regression modeling identified factors associated with worse pain scores (P < 0.05). RESULTS: Seven hundred twenty-seven surveys were analyzed, in which 73.4% reported RLP and 70.4% reported PLP. Median residual PROMIS scores were 46.6 [interquartile range (IQR), 41-52] for RLP Intensity, 56.7 (IQR, 51-61) for RLP Behavior, and 55.9 (IQR, 41-63) for RLP Interference. Similar scores were calculated for PLP parameters: 46.8 (IQR, 41-54) for PLP Intensity, 56.2 (IQR, 50-61) for PLP Behavior, and 54.6 (IQR, 41-62) for PLP Interference. Female sex, lower education, trauma-related amputation, more proximal amputation, and closer to time of amputation increased odds of PLP. Female sex, lower education, and infection/ischemia-related amputation increased odds of RLP. CONCLUSION: This survey-based analysis provides quantitative benchmark data regarding RLP and PLP in amputees with more granularity than has previously been reported.

Long-term consequences of pelvic trauma patients with thromboembolic disease treated with inferior vena caval filters.

BACKGROUND: The use of inferior vena cava (IVC) filters for prevention of pulmonary embolism (PE) in high-risk trauma patients is well accepted. High rates of recurrent venous thrombosis, however, and postthrombotic syndrome (PTS) have been reported in nonsurgical patients with medical comorbidities. Patients with pelvic trauma and thromboembolic disease have a unique thrombogenic pathophysiology, and the long-term consequences of filter placement in these patients are unknown. We sought to evaluate the outcomes of patients who sustained pelvic trauma, and who developed venous thrombosis and were treated with a vena caval filter. METHODS: A cohort of 102 consecutive patients was treated for a pelvic or acetabular fracture who developed deep vein thrombosis (DVT) preoperatively and had a caval filter placed. Thromboembolic events and complications were evaluated by both retrospective chart review and a prospective questionnaire. Eighty-eight patients (86%) returned the questionnaire at an average follow-up of 4 years. RESULTS: No patients were readmitted to the hospital for recurrent venous thrombosis or PE. Six patients (7%) described new swelling in the lower extremities, and one (1%) demonstrated evidence of PTS. No deaths occurred related to PE. CONCLUSIONS: The use of IVC filters appears to be safe and effective in preventing PE in patients with pelvic trauma and established venous thrombosis. The risk of recurrent DVT is low and PTS is negligible in these patients. Filter placement use is not associated with the same long-term complications as in patients with thrombosis because of chronic medical comorbidities.

Transtibial Amputation Outcomes Study (TAOS): Comparing Transtibial Amputation With and Without a Tibiofibular Synostosis (Ertl) Procedure.

The optimal technique for a transtibial amputation in a young, active, and healthy patient is controversial. Proponents of the Ertl procedure (in which the cut ends of the tibia and fibula are joined with a bone bridge synostosis) argue that the residual limb is more stable which confers better prosthetic fit and improved function especially among high-performing individuals. At the same time, the Ertl procedure is associated with longer operative and healing time and may be associated with a higher complication rate compared with the standard Burgess procedure. The TAOS is a prospective, multicenter randomized trial comparing 18-month outcomes after transtibial amputation using the Ertl versus Burgess approach among adults aged 18 to 60. The primary outcomes include surgical treatment for a complication and patient-reported function. Secondary outcomes include physical impairment, pain, and treatment cost.

Improving operating room efficiency via an interprofessional approach.

BACKGROUND: Third-party payer reimbursements will likely continue to decrease. Therefore, it is imperative for operating rooms (ORs), often a hospital's largest revenue source, to improve efficiency. We report the outcome after 3 years of a lean, Six Sigma program to improve OR utilization. METHODS: In January 2011, our hospital system instituted a facility-wide approach to address the problem of OR efficiency. Interprofessional teams were formed to examine all aspects of OR use. An OR Governance Committee consisting of Department Chairs, nursing and senior administration oversaw the project. RESULTS: Outpatients' readiness on time for surgery increased from 59% to 95%, while first case on-time starts improved from 32% to 73%. Block utilization went from 68% to 74% and actual room utilization improved from 56% to 68%. The number of cases increased by 9%. Overtime went from 7% of total to 4%, so personnel costs decreased 14% despite 26% more employees. There was a reduction in annual voluntary OR staff turnover from 28% to 11%. Revenues increased more than 10% annually. CONCLUSION: A concerted effort to optimize OR performance resulted in marked improvements in access, overall case efficiency, staff satisfaction, and financial performance.

Does Syndesmotic Injury Have a Negative Effect on Functional Outcome? A Multicenter Prospective Evaluation.

OBJECTIVE: To evaluate the effect of syndesmotic disruption on the functional outcomes of Weber B, SE4 ankle fractures treated operatively. SETTING: Multicenter trauma hospitals. PATIENTS: Data were prospectively gathered during a previous, multicenter randomized trial including 242 patients (136 women, 106 men) from 9 trauma centers with operatively treated Weber B SE4 ankle fractures. There were 81 patients (35%) with syndesmotic instability confirmed intraoperatively after fibula fixation. INTERVENTION: Functional evaluations were performed postoperatively at 6, 12, 26, and 52 weeks. The presence of symptomatic hardware and peroneal tendon discomfort was evaluated with 9-12 months of follow-up. MAIN OUTCOME MEASURES: Functional outcomes evaluated included Short Musculoskeletal Function Assessment (SMFA), Bother index, and American Orthopaedic Foot and Ankle Society (AOFAS) scores. The recovery curve of the 2 groups was analyzed using a mixed linear regression analysis for repeated measures and included gender and race in the model. Symptomatic hardware and peroneal tendon discomfort were compared between the 2 groups with a χ analysis. RESULTS: The adjusted mean linear regression analyses demonstrated that patients without a syndesmotic injury had better functional outcomes for some outcome measures. SMFA scores at 12 weeks were statistically lower in patients without syndesmotic injury (P = 0.02), but not at other visits. AOFAS scores were significantly higher (P = 0.0006), and Bother index trended toward lower results (P = 0.07) in patients without syndesmotic injury at all time points. Isolated analyses (T-tests) at 1 year demonstrated a difference in the SMFA (P = 0.04) and Bother index (P = 0.05), but not the AOFAS (P = 0.21). Men consistently demonstrated better recovery than women for all outcomes, whereas race was not significant for any measure. Symptomatic hardware and peroneal tendon irritation was not statistically different between the groups. CONCLUSIONS: The recovery curves after ankle fractures were different based on syndesmotic injury. However, the difference was at the limit of clinical significance. Syndesmotic injury has a slightly detrimental effect on outcomes of operatively treated Weber B SE4 fractures. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.