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1.  Unique aspects of pain reduction in osteoarthritis of the knee with LMWF-5A 
Osteoarthritis of the knee (OAK) is a common form of arthritis that can lead to substantial pain and disability. This commentary highlights key aspects of the recently published phase 3 A Efficacy and Safety Study of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee (SPRING) study. SPRING (NCT01839331) was a multicenter, randomized, vehicle-controlled, double-blind trial that evaluated the safety and efficacy of the low-molecular-weight fraction of 5% human serum albumin (LMWF-5A) for treatment of pain, measured by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale, in patients with symptomatic OAK (N=329). Patients in this study reflected many characteristics of “real-world” individuals with OAK, with a broad range of disease severity and disability. The most important finding from this study was that treatment with a single intra-articular injection of LMWF-5A led to significant pain reduction in the patients with objective radiographic evidence of severe disease and joint deterioration (Kellgren-Lawrence grade 3; P=0.04 and Kellgren-Lawrence grade 4; P=0.02). The magnitude of pain reduction in the entire cohort treated with LMWF-5A was 42% from baseline and the treatment effect compared with vehicle control (estimated difference in WOMAC pain, −0.25; P=0.004) was also notable, especially relative to a previously reported study of hyaluronic acid, in which only a marginally significant treatment effect was observed (mean difference in WOMAC pain compared with control, −0.15; P=0.047). Significant improvement in physical function observed with LMWF-5A (P=0.04) was also noted and suggests that LMWF-5A may provide therapeutic benefit for those who are limited in the activities of daily living. Intra-articular injection of LMWF-5A was well tolerated, and the adverse event profile was similar to that of control. These results demonstrate significant benefit of LMWF-5A for patients with greatest disability (Kellgren-Lawrence grades 3 and 4) and highest therapeutic need who have limited pharmacologic options for relief of pain associated with OAK.
doi:10.2147/OARRR.S71537
PMCID: PMC5045122  PMID: 27790041
human serum albumin; knee; osteoarthritis; pain; Kellgren-Lawrence
2.  A case of long term survival with skeletal only metastatic breast cancer 
Highlights
•Patients with limited, skeletal only recurrent breast Ca have better survival than widespread metastatic disease.•The osteotropic phenotype may directly affect mortality.
Introduction
The prognosis of patients with metastatic breast cancer is very poor. Because of this, treatment of skeletal metastasis is often palliative with limited goals rather than cure. However, there are those patients, such as presented here, who survive for an extended time.
Presentation of case
This thirty-six year old female presented with lytic lesions to one ulna and rib five years after mastectomy for breast cancer. Despite radiation and chemotherapy, the ulnar lesion expanded and resulted in an elbow dislocation. The rib lesion was resected and the arm amputated above the elbow. She developed local recurrence in both her above elbow amputation stump and chest wall and a more proximal below shoulder amputation was performed with resection of chest wall lesion. Even though she had locally aggressive disease, she has survived for 31 years after diagnosis without any evidence of disease.
Discussion
Reports of metastatic breast cancer survival indicate the five year survival to be 15%. There have been few reports indicating that those patients with skeletal only or oligometastatic disease have improved prognosis. It is not clear what biological properties of these tumors results in the improved survival.
Conclusion
This case highlights the challenges of giving patients the optimal treatment in the light of limited ability to predict prognosis. It also highlights the need to further investigate the phenotypes of breast cancer that can, despite metastatic disease and with modern treatment go on to long survival. In addition this case demonstrates the importance of long term followup.
doi:10.1016/j.ijscr.2014.12.017
PMCID: PMC4334204  PMID: 25556998
Breast cancer; Oligometastasis; Survival; Amputation
3.  Hip Arthroscopic Portal Bridge Retraction Technique for Improved Peripheral Compartment Visualization 
Arthroscopy Techniques  2014;3(4):e501-e503.
Hip arthroscopy has been shown to be an effective technique in managing an increasingly widening set of indications for hip pathology. In any arthroscopic procedure, obtaining good visualization is one of the most critical components to performing a successful operation. Whereas other authors have described various techniques for improving visualization, we describe an additional simple but effective technique in this report. We describe the use of a retracting suture bridge between portal sites that allows for improved visualization of the peripheral compartment in hip arthroscopy, as well as other arthroscopic procedures.
doi:10.1016/j.eats.2014.05.011
PMCID: PMC4175157  PMID: 25264511
4.  A Randomized Clinical Trial to Evaluate Two Doses of an Intra-Articular Injection of LMWF-5A in Adults with Pain Due to Osteoarthritis of the Knee 
PLoS ONE  2014;9(2):e87910.
Objective
The Low Molecular Weight Fraction of 5% human serum Albumin (LMWF-5A) is being investigated as a treatment for knee pain from osteoarthritis.
Methods
This was a multicenter randomized, vehicle-controlled, double-blind, parallel study designed to evaluate the safety and efficacy of two doses of an intra-articular injection of LMWF-5A. Patients with symptomatic knee osteoarthritis were randomized 1∶1∶1∶1 to receive a single 4 mL or 10 mL intra-articular knee injection of either LMWF-5A or vehicle control (saline). The primary efficacy endpoint was the difference between treatment groups in the Western Ontario and McMaster Universities (WOMAC) pain change from baseline over 12 weeks. Safety was examined as the incidence and severity of adverse events (AEs).
Results
A total of 329 patients were randomized and received treatment. LMWF-5A resulted in a significant decrease in pain at 12 weeks compared to vehicle control (−0.93 vs −0.72; estimated difference from control: −0.25, p = 0.004); an injection volume effect was not observed (p = 0.64). The effect of LMWF-5A on pain was even more pronounced in patients with severe knee OA (Kellgren Lawrence Grade IV): the estimated difference from control was −0.42 (p = 0.02). Adverse events were generally mild and were similar in patients who received vehicle control (47%) and LMWF-5A (41%).
Conclusions
This clinical trial demonstrated that LMWF-5A is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee.
Trial Registration
ClinicalTrials.gov NCT01839331
doi:10.1371/journal.pone.0087910
PMCID: PMC3912151  PMID: 24498399
5.  Relationship Express: A Pilot Program to Teach Anesthesiology Residents Communication Skills 
Background
The Accreditation Council for Graduate Medical Education requires residency programs to teach 6 core competencies and to provide evidence of effective standardized training through objective measures. George Washington University's Department of Anesthesiology and Critical Care Medicine implemented a pilot program to address the interpersonal and communication skill competency. In this program, we aimed to pilot the Relationship Express model, a series of exercises in experiential learning to teach anesthesiology residents to build effective relationships with patients in time-limited circumstances. The purpose of this paper is to describe the application of this model for anesthesiology training.
Methods
A total of 7 first-year clinical anesthesiology residents participated in this pilot study, and 4 residents completed the entire program for analysis purposes. Relationship Express was presented in three 1.5-hour sessions: (1) introduction followed by 2-case, standardized patient pretest with feedback to residents from faculty observers; (2) interpersonal and communication skills didactic workshop with video behavior modeling; and (3) review discussion followed by 2-case, standardized patient posttest and evaluation.
Results
Modified Brookfield comments revealed the following themes: (1) time constraints were realistic compared with clinical practice; (2) admitting errors with patients was difficult; (3) patients were more aware of body language than anticipated; (4) residents liked the group discussions and the video interview; (5) standardized patients were convincing; and (6) residents found the feedback from faculty and standardized patients helpful.
Conclusions
Resident retrospective self-assessment and learning comments confirm the potential value of the Relationship Express model. This program will require further assessment and refinement with a larger number of residents.
doi:10.4300/JGME-D-10-00012.1
PMCID: PMC3010947  PMID: 22132285
6.  Alveolar Soft Part Sarcoma Metastatic to Small Bowel Mucosa Causing Polyposis and Intussuseption 
Sarcoma  2001;5(3):133-137.
A report of alveolar soft part sarcoma metastatic to the small bowel is presented. Hematogenous metastases to the small bowel from primary tumors outside the abdominal cavity are uncommon, and most remain asymptomatic and are not discovered until autopsy. However, small bowel metastases can lead to intestinal obstruction, intussuseption or even perforation. While metastases to the small bowel have been described for other tumor types, including melanoma and lung cancer, this is extremely uncommon for sarcoma, especially alveolar soft part sarcoma. We describe a 42-year-old male with a long history of alveolar soft part sarcoma, metastatic to the lung and brain, who developed an intussuseption from metastases to the small bowel.
doi:10.1080/13577140120048584
PMCID: PMC2408368  PMID: 18521439

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