Management of partial-thickness rotator cuff tears with autologous adipose-derived regenerative cells is safe and more effective than injection of corticosteroid.

Symptomatic, partial-thickness rotator cuff tears (sPTRCT) are problematic. This study tested the hypothesis that management of sPTRCT with injection of fresh, uncultured, unmodified, autologous, adipose-derived regenerative cells (UA-ADRCs) is safe and more effective than injection of corticosteroid even in the long run. To this end, subjects who had completed a former randomized controlled trial were enrolled in the present study. At baseline these subjects had not responded to physical therapy treatments for at least 6 weeks, and were randomly assigned to receive respectively a single injection of UA-ADRCs (n = 11) or a single injection of methylprednisolone (n = 5). Efficacy was assessed using the ASES Total score, pain visual analogue scale (VAS), RAND Short Form-36 Health Survey and range of motion at 33.2 ± 1.0 (mean ± SD) and 40.6 ± 1.9 months post-treatment. Proton density, fat-saturated, T2-weighted MRI of the index shoulder was performed at both study visits. There were no greater risks connected with injection of UA-ADRCs than those connected with injection of corticosteroid. The subjects in the UA-ADRCs group showed statistically significantly higher mean ASES Total scores than the subjects in the corticosteroid group. The MRI scans at 6 months post-treatment allowed to "watch the UA-ADRCs at work".

Why and how to use the body's own stem cells for regeneration in musculoskeletal disorders: a primer.

BACKGROUND: Recently, the management of musculoskeletal disorders with the patients' own stem cells, isolated from the walls of small blood vessels, which can be found in great numbers in the adipose tissue, has received considerable attention. On the other hand, there are still misconceptions about these adipose-derived regenerative cells (ADRCs) that contain vascular-associated pluripotent stem cells (vaPS cells) in regenerative medicine. METHODS: Based on our previous publications on this topic, we have developed a concept to describe the significance of the ADRCs/vaPS cells in the field of orthobiologics as briefly as possible and at the same time as precisely as possible. RESULTS: The ADRCs/vaPS cells belong to the group of orthobiologics that are based on autologous cells. Because the latter can both stimulate a patient's body's localized self-healing power and provide new cells that can integrate into the host tissue during the healing response when the localized self-healing power is exhausted, this group of orthobiologics appears more advantageous than cell-free orthobiologics and orthobiologics that are based on allogeneic cells. Within the group of orthobiologics that are based on autologous cells, enzymatically isolated, uncultured ADRCs/vaPS cells have several advantages over non-enzymatically isolated cells/microfragmented fat as well as over uncultured bone marrow aspirate concentrate and cultured cells (adipose-derived stem cells, bone marrow-derived mesenchymal stem cells). CONCLUSIONS: The use of ADRCs/vaPS cells can be seamlessly integrated into modern orthopedic treatment concepts, which can be understood as the optimization of a process which-albeit less efficiently-also takes place physiologically. Accordingly, this new safe and effective type of treatment is attractive in terms of holistic thinking and personalized medicine.

Bilateral internal iliac branch device with ipsilateral deployment.

Iliac branch endograft devices offer an elegant solution to preserve perfusion to the internal iliac artery when treating aortoiliac aneurysms; however, they are difficult to perform when bilateral access is not available owing to aortoiliac anatomy or previous endovascular aortic aneurysm repair. We present a technique to perform iliac branch endograft deployment from ipsilateral access in a patient with a prior EVAR endovascular aortic aneurysm repair, obviating the need for a difficult up-and-over access.

Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study.

BACKGROUND: This study tested the hypothesis that treatment of symptomatic, partial-thickness rotator cuff tears (sPTRCT) with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated from lipoaspirate at the point of care is safe and more effective than corticosteroid injection. METHODS: Subjects aged between 30 and 75 years with sPTRCT who did not respond to physical therapy treatments for at least 6 weeks were randomly assigned to receive a single injection of an average 11.4 × 106 UA-ADRCs (in 5 mL liquid; mean cell viability: 88%) (n = 11; modified intention-to-treat (mITT) population) or a single injection of 80 mg of methylprednisolone (40 mg/mL; 2 mL) plus 3 mL of 0.25% bupivacaine (n = 5; mITT population), respectively. Safety and efficacy were assessed using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), RAND Short Form-36 Health Survey, and pain visual analogue scale (VAS) at baseline (BL) as well as 3 weeks (W3), W6, W9, W12, W24, W32, W40, and W52 post treatment. Fat-saturated T2-weighted magnetic resonance imaging of the shoulder was performed at BL as well as at W24 and W52 post treatment. RESULTS: No severe adverse events related to the injection of UA-ADRCs were observed in the 12 months post treatment. The risks connected with treatment of sPTRCT with UA-ADRCs were not greater than those connected with treatment of sPTRCT with corticosteroid injection. However, one subject in the corticosteroid group developed a full rotator cuff tear during the course of this pilot study. Despite the small number of subjects in this pilot study, those in the UA-ADRCs group showed statistically significantly higher mean ASES total scores at W24 and W52 post treatment than those in the corticosteroid group (p < 0.05). DISCUSSION: This pilot study suggests that the use of UA-ADRCs in subjects with sPTRCT is safe and leads to improved shoulder function without adverse effects. To verify the results of this initial safety and feasibility pilot study in a larger patient population, a randomized controlled trial on 246 patients suffering from sPTRCT is currently ongoing. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT02918136. Registered September 28, 2016, https://clinicaltrials.gov/ct2/show/NCT02918136. LEVEL OF EVIDENCE: Level I; prospective, randomized, controlled trial.

Long-term durability of a physician-modified endovascular graft.

We present a unique assessment confirming the long-term durability of a physician-modified endograft deployed as part of an Investigational Device Exemption clinical trial (NCT# 01538056). After receiving an intact postmortem aorta 7 years after the index procedure, we performed microcomputed tomography, necropsy, and metallurgical analysis on the specimen. Microcomputed tomography showed a single strut fracture not noted during previous surveillance. Necropsy revealed no graft fabric compromise, and examination of all three visceral fenestrations showed excellent alignment with no evidence of degradation. Analysis of the strut fracture implicated an initially small, fatigue-induced crack that likely succumbed during postmortem handling.

A reliable method for renal volume measurement and its application in fenestrated endovascular aneurysm repair.

OBJECTIVE: Renal volume has been shown to correlate with renal function. Renal volume and renal function both decline steadily in the sixth decade of life and beyond. We sought to assess (1) the inter-rater reliability for manually measuring renal volume using computed tomography and (2) change in renal volume over time as it relates to renal function in fenestrated endovascular aortic aneurysm repair (FEVAR). METHODS: This study was conducted as part of a physician-sponsored investigational new device (#NCT01538056). First, 30 consecutive kidneys of preoperative FEVAR patients were independently measured by two raters using manual segmentation and three-dimensional modeling software. Renal volumes were calculated and compared. Intraclass correlation was calculated between the two observers. Second, renal volumes were then recorded for 85 patients undergoing FEVAR with follow-up out to 5 years. Demographic data, comorbidities, creatinine, glomerular filtration rate (GFR), renal artery stenosis or occlusion, and bilateral renal volume measurements were analyzed. Multivariate analysis was performed to delineate association of these variables with total renal volume (TRV). RESULTS: The intraclass correlation coefficient for our renal volume measurements was 0.97 (95% confidence interval, 0.81-0.99), indicating excellent correlation. Renal volume was strongly correlated with GFR. Our multivariate analysis model predicts a 17.9 mL/min increase in GFR with each 20% increase in TRV. After adjustment for all other known correlates of renal function, renal volume remained as the only significant predictor of renal function. CONCLUSIONS: Renal volume can be measured with high reliability using manual segmentation and computed tomography scans. In our baseline analysis, TRV was strongly correlated with renal function. These findings support the potential for renal volume as a surrogate for renal function.

Limb Salvage Does Not Predict Functional Limb Outcome after Revascularization for Traumatic Acute Limb Ischemia.

BACKGROUND: Traumatic vascular injury leading to acute limb ischemia (ALI) is an uncommon problem with a potential for high morbidity. We describe a contemporary series of patients with traumatic ALI managed primarily by vascular surgeons at a tertiary referral center and review factors associated with limb salvage and functional limb outcomes. METHODS: We conducted a single institution, retrospective review of all patients requiring revascularization for upper extremity (UE) and lower extremity (LE) ALI secondary to trauma from 2013 to 2016. Demographic data, transfer timing, injury severity score (ISS), Rutherford classification (RC), preoperative imaging, level of occlusion, procedural information, fasciotomy characteristics, and discharge disposition were reviewed. Outcome measures included limb salvage and functional limb outcomes. RESULTS: We identified 68 patients with traumatic ALI requiring revascularization. The majority of patients had moderate ISS scores, were RC 2a or 2b on presentation (65%), were transferred from another institution (53%), and underwent preoperative imaging (62%) with expeditious time to operation (median 4.5 hr). The most common location of vascular injury for UE was axillary-brachial (88%) and for LE was femoral-popliteal (69%). Open vascular procedures dominated the treatment strategy, and the median number of operations was 3. Fasciotomy was performed in 25% of UE and 58% of LE injuries. Shunts were utilized in only 2 patients. Overall LS was 94% for UE and 78% for LE. The median length of stay (LOS) was 11 days, with 25% of patients discharged to a skilled nursing facility. Follow-up was obtained for 59% of patients. For UE injuries, 57% of patients had no or minimal functional deficits, while 33% had major functional deficits and 10% underwent amputation. For LE injuries, 68% of patients had no or minimal functional deficits, while 6% had major functional deficits, and 26% had undergone amputation. Rutherford class and the number of operations performed were independent predictors of amputation and functional limb at follow-up in our logistic regression model (P < 0.05). CONCLUSIONS: Revascularization for traumatic ALI yields high limb salvage rates in patients with RC 1 and 2 ischemia and patients with UE injuries. However, limb salvage does not necessarily equate to good functional outcomes. This signifies the complex nature of injuries in this patient population, especially when multiple operations are required.

Not Missing the Future: A Call to Action for Investigating the Role of Regenerative Medicine Therapies in Pediatric/Adolescent Sports Injuries.

In August 2016, a group including sport medicine clinicians, researchers, and a bioethicist met in Vail, Colorado to discuss regenerative medicine and its potential role in youth sports injuries. There was consensus that a call to action is urgently needed to understand the current evidence base, the risks and rewards, and future directions of research and clinical practice for regenerative medicine therapies in youth sports. We present here a summary of our meeting, which was supported by the National Youth Sports Health and Safety Institute (NYSHSI), a partnership between the American College of Sports Medicine (ACSM) and Sanford Health. The group's goal is to educate practitioners and the public, and to pioneer a means of accumulating meaningful clinical data on regenerative medicine therapies in pediatric and adolescent athletes.

The anatomic location of digital glomus tumor recurrences.

PURPOSE: We examined the anatomic location of recurrences of digital glomus tumors treated with surgical excision to make inferences on the causes of recurrence. METHODS: We retrospectively reviewed 12 cases of glomus tumors of the hand treated surgically over an 8-year period. Two of these patients presented with recurrences after previous glomus tumor excision surgery elsewhere. The location of recurrences, duration of symptoms, gender, revision surgeries, and histological specimens were analyzed. RESULTS: All tumors developed in the periungual and subungual area of the digits. Five of the 12 patients had recurrences, with one of these patients having a second recurrence after revision surgery. All recurrent tumors occurred in new, separate locations from the original lesions. The recurrences presented from 2 months to 5 years after the initial surgery. All surgical specimens from the index surgeries, as well as revision procedures, were examined by a pathologist and confirmed to be glomus tumors. There were no discernible differences in the histology features of the tumors that recurred compared to those that did not. CONCLUSIONS: Traditionally, recurrences of digital glomus tumors after surgical excision are thought to be rare. Inadequate resection was considered the likely cause in most cases. However, recurrent symptoms might be attributed to small, synchronous, satellite lesions not detected during the original surgery. A careful preoperative and intraoperative examination for synchronous lesions should be made, and patients should be informed of the risk of recurrent symptoms.

The effect of rotator cuff tears on surgical outcomes after type II superior labrum anterior posterior tears in patients younger than 50 years.

BACKGROUND: Rotator cuff injury in the setting of type II superior labrum anterior posterior lesions is a common finding. Although predictable surgical outcomes can be expected after type II superior labrum anterior posterior repair, the effect of rotator cuff tears on surgical outcome is unknown. HYPOTHESIS: Rotator cuff tears will not negatively affect surgical outcome of type II superior labrum anterior posterior repairs. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: The study group included 93 patients younger than 50 years who underwent arthroscopic type II superior labrum anterior posterior repair and were available for review at a minimum of 2 years after surgery. Group 1 patients were identified as having normal rotator cuffs at the time of repair. Group 2 patients were identified as having rotator cuff injury at the time of repair (either partial-thickness or full-thickness tears). Statistical analysis was performed comparing the postoperative University of California, Los Angeles shoulder scores and overall improvement in University of California, Los Angeles score using the Student t test for significance. RESULTS: Mean follow-up was 2.54 years; 52.7% of patients had evidence of rotator cuff tears at the time of surgery. The mean postoperative University of California, Los Angeles score for group 1 was 32.9 (improvement of 11.0), and the mean postoperative University of California, Los Angeles score for group 2 was 33.3 (improvement of 12.2). There was not a significant difference in any of the outcome measures between groups. CONCLUSION: Predictable short-term surgical results and return to activity can be expected after repair of type II superior labrum anterior posterior lesions in patients younger than 50 years who have coexistent rotator cuff tear. Although cuff lesions did not have a negative effect on the short-term outcome in patients with type II superior labrum anterior posterior lesions, longer-term follow-up is needed to determine natural history of this pathologic condition.

Proximal biceps tendon--a biomechanical analysis of the stability at the bicipital groove.

The subscapularis tendon, coracohumeral ligament, and transverse humeral ligament are all believed to contribute to biceps tendon stability within the bicipital groove. In order to examine the relative contribution of these soft tissue structures to proximal biceps tendon stability, 11 fresh frozen cadaveric shoulder specimens were prepared and mounted onto a custom jig. A three-dimensional digitizer was utilized to record biceps tendon excursion in various shoulder positions. In sequential order, these structures were then sectioned, and biceps tendon excursion was again recorded. We found that sectioning of the subscapularis tendon significantly increased biceps tendon excursion, compared to intact specimens (8.1 +/- 4.1 mm vs. 4.3 +/- 3.6 mm; p < 0.006). In contrast, isolated sectioning of the transverse humeral ligament or the coracohumeral ligament did not significantly increase biceps excursion (5.4 +/- 2.5 mm, p = 0.26; 5.6 +/- 1.3 mm, p = 0.24). When two structures were sectioned, significant excursion in the biceps tendon only occurred in specimens where the subscapularis tendon was one of the sectioned structures. The preliminary data suggest that, of the three tested soft tissue structures, the subscapularis tendon is the most important stabilizer of the proximal biceps and that clinically significant lesions of the proximal biceps tendon may be associated with a defect in the subscapularis tendon.

Sciatic nerve palsy after primary total hip arthroplasty: a new perspective.

More than half of sciatic nerve palsies after primary total hip arthroplasties are unexplained. In 2 such cases, magnetic resonance imaging localized compressive injury between the ischial tuberosity and femoral insertion of the gluteus maximus. After these cases, we hypothesized that during limb positioning, the sciatic nerve is compressed by the gluteus maximus tendon. We present the magnetic resonance imaging findings from these 2 cases and compare the number of sciatic nerve palsies in patients with release of the gluteus maximus tendon to patients without release during primary total hip arthroplasty. There were no cases of sciatic nerve palsy when the gluteus maximus was released, compared with 3 cases in the control group.