Single-Dose Intravenous Tranexamic Acid Does Not Increase Venous Thromboembolic Rate or Complication Rate During Hip Arthroscopy.

PURPOSE: To determine whether tranexamic acid (TXA) is safe to administer preoperatively in patients undergoing hip arthroscopy by comparing the venous thromboembolic rate and complication rate between patients who did and did not receive TXA preoperatively. METHODS: This was a multicenter consecutive-cohort series of patients who underwent arthroscopic hip surgery between 2014 and 2021. The 2 cohorts comprised patients who did and did not receive TXA preoperatively (single dose of 1-2 g), after a practice change. Data were collected via chart review. Surgical outcomes included days until follow-up, visual analog scale pain score at first follow-up, total operating room (OR) time, number of arthroscopic fluid bags (3 L/bag), and complications and revision operations up to 1 year after surgery. The Mann-Whitney U test was performed for continuous variables, and the χ2 test, for categorical variables. RESULTS: A total of 862 patients were identified: 449 (52%) received TXA and 413 (48%) did not. Patient demographic characteristics including age, sex, height, weight, body mass index, smoking status, and procedures performed, as well as number of anchors used (3.5 anchors for no TXA vs 3.7 anchors for TXA) and traction time (38 minutes for no TXA vs 40 minutes for TXA), did not significantly differ between groups. Significantly more patients underwent prior hip arthroscopy in the TXA group (n = 45; primary, n = 404) than in the group that did not receive TXA (n = 25; primary, n = 388) (P = .03). Visual analog scale pain scores at the first follow-up visit (2.61 for no TXA vs 2.62 for TXA, P = .62) and the need for subsequent revision surgery (24 patients with no TXA vs 18 patients with TXA, P = .68) were not significantly different. TXA use was associated with less arthroscopic fluid utilization (5.9 bags of 3 L of fluid for no TXA vs 5.3 bags of 3 L of fluid for TXA, P < .01) and less total OR time (99.5 minutes for no TXA vs 90.0 minutes for TXA, P < .01). There was a higher overall complication rate in the group that did not receive TXA (n = 27) than in the group that did (n = 10) (P = .01). However, if lateral femoral cutaneous nerve neurapraxia was excluded, then no difference in complication rate was observed (P = .24). CONCLUSIONS: There was no difference in the incidence of venous thromboembolic complications between patients who did and did not receive TXA preoperatively. We observed a lower overall complication rate in patients who received TXA preoperatively; however, this normalized between the 2 groups when lateral femoral cutaneous nerve neuritis was excluded. No difference in early pain control or revision surgery rate was observed between groups. Although there was statistically less arthroscopic fluid utilization and less total OR time in the group that received TXA, further studies are needed to clarify whether this is clinically meaningful. Preoperatively administered TXA is a safe adjunct medication in patients undergoing arthroscopic hip surgery. LEVEL OF EVIDENCE: Level III, retrospective multicenter consecutive series.

A pharmacokinetic study of extended-release buprenorphine in cynomolgus monkeys (Macaca fasicularis).

BACKGROUND: A novel buprenorphine (BUP) extended-release formulation (BUP-XR) produced as a lipid-encapsulated, low viscosity BUP suspension for subcutaneous (SC) injection to control pain was evaluated for pharmacokinetics and safety in four adult male cynomolgus monkeys. METHODS: Each animal was given 0.2 mg/kg reformulated BUP-XR SC. Clinical observations were made during the course of the study. Blood samples were obtained from each animal before BUP-XR administration, 6, 24, 48, 72, and 96 h post-BUP-XR injection. Plasma levels of buprenorphine were analyzed using HPLC-MS/MS. The PK values calculated included peak plasma concentration of the BUP analyte, time to peak plasma concentration, plasma half-life, area under the plasma concentration-time curve, clearance, apparent volume of distribution, and elimination rate constant (Cmax , Tmax , T½ , AUC0-t , CL, Vd, and Ke, respectively). RESULTS: Observable adverse clinical signs were not detected. BUP concentration peaked from 6 to 48 h, then declined in a linear fashion. Quantifiable plasma BUP was measured in all monkeys at all time points. Results indicate that a single BUP-XR dose at 0.2 mg/kg can reliably provide plasma levels of BUP reported in the literature to be therapeutically relevant for up to 96 h. CONCLUSIONS: Because of the lack of any clinical observations or adverse effects at the injection site or absence of observable abnormal behaviors, it may be concluded that the use of BUP-XR is safe and efficacious in this species of non-human primate at the dose regimen described in this study for up to 96 h post-administration.

Return to Sport After Knee Injuries in Collegiate Wrestling.

Background: Wrestling is known to be a sport of relatively high injury incidence, and knee injuries account for a large percentage of those injuries. Treatment of these injuries varies considerably depending on injury and wrestler characteristics, leading to variability in complete recovery and return to sport (RTS). The purpose of this study was to evaluate injury trends, treatment strategies, and RTS characteristics after knee injuries in competitive collegiate wrestling. Methods: NCAA Division I collegiate wrestlers who sustained knee injuries between January 2010 and May 2020 were identified using an institutional Sports Injury Management System (SIMS). Wrestling-related knee, meniscus, and patella injuries were identified, and treatment strategies were documented to investigate potential recurrent injury trends. Descriptive statistics were used to quantify the number of days, practices, and competitions missed, return to sport times, and recurrent injuries among wrestlers. Results: Overall, 184 knee injuries were identified. After excluding non-wrestling injuries (n=11), 173 injuries remained (77 wrestlers). The mean age at time of injury was 20.8 ± 1.4 years, and the mean BMI was 25.9 ± 3.8 kg/m2. There were 135 primary injuries (74 wrestlers), which consisted of 72 (53%) ligamentous injuries, 30 (22%) meniscus injuries, 14 patellar injuries (10%), and 19 other injuries (14%). The majority of ligamentous injuries (93%) and patellar injuries (79%) were treated non-operatively, while the majority of meniscus tears (60%) underwent surgery. Twenty-three wrestlers (22%) sustained recurrent knee injuries, of which 76% were treated non-operatively after their initial injury. Recurrent injuries consisted of 12 (32%) ligamentous injuries, 14 (37%) meniscus injuries, eight (21%) patellar injuries, and four (11%) other injuries. Fifty percent of recurrent injuries were treated operatively. When comparing recurrent injuries to primary injuries, recurrent injuries had a significantly longer return to sport time (Recurrent 68.3 ± 96.0 days vs. Primary 26.0 ± 56.4 days, p=0.01). Conclusion: The majority of NCAA Division I collegiate wrestlers who sustained knee injuries were initially treated non-operatively, and approximately one in five wrestlers sustained recurrent injuries. Return to sport time was significantly increased after a recurrent injury. Level of Evidence: IV.

Food Insecurity Is Common in the Orthopedic Trauma Population at a Rural Academic Trauma Center.

Background: Food insecurity is an increasingly recognized public health issue. Identifying risk factors for food insecurity would support public health initiatives to provide targeted nutrition interventions to high-risk individuals. Food insecurity has not been investigated in the orthopedic trauma population. Methods: From April 27, 2021 to June 23, 2021, we surveyed patients within six months of operative pelvic and/or extremity fracture fixation at a single institution. Food insecurity was assessed using the validated United States Department of Agriculture Household Food Insecurity questionnaire generating a food security score of 0 to 10. Patients with a food security score ≥ 3 were classified as Food Insecure (FI) and patients with a food security score < 3 were classified as Food Secure (FS). Patients also completed surveys for demographic information and food consumption. Differences between FI and FS for continuous and categorical variables were evaluated using the Wilcoxon sum rank test and Fisher's exact test, respectively. Spearman's correlation was used to describe the relationship between food security score and participant characteristics. Logistic regression was used to determine the relationship between patient demographics and odds of FI. Results: We enrolled 158 patients (48% female) with a mean age of 45.5 ± 20.3 years. Twenty-one patients (13.3%) screened positive for food insecurity (High security: n=124, 78.5%; Marginal security: n=13, 8.2%; Low security: n=12, 7.6%; Very Low security: n=9, 5.7%). Those with a household income level of ≤ $15,000 were 5.7 times more likely to be FI (95% CI 1.8-18.1). Widowed/single/divorced patients were 10.2 times more likely to be FI (95% CI 2.3-45.6). Median time to the nearest full-service grocery store was significantly longer for FI patients (t=10 minutes) than for FS patients (t=7 minutes, p=0.0202). Age (r= -0.08, p=0.327) and hours working (r= -0.10, p=0.429) demonstrated weak to no correlation with food security score. Conclusion: Food insecurity is common in the orthopedic trauma population at our rural academic trauma center. Those with lower household income and those living alone are more likely to be FI. Multicenter studies are warranted to evaluate the incidence and risk factors for food insecurity in a more diverse trauma population and to better understand its impact on patient outcomes. Level of Evidence: III.

Outcomes of Arthroscopic Decompression of the Anterior Inferior Iliac Spine: A Systematic Review and Meta-analysis.

BACKGROUND: Anterior inferior iliac spine (AIIS) impingement has been increasingly recognized as a source of extra-articular impingement and hip pain. However, no aggregate data analysis of patient outcomes after AIIS decompression has been performed. PURPOSE: To evaluate outcomes after arthroscopic AIIS decompression. STUDY DESIGN: Meta-analysis; Level of evidence, 4. METHODS: A systematic review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. PubMed, EMBASE, and Cochrane Central Register of Controlled Trials were queried for all English-language studies reporting outcomes of arthroscopic AIIS decompression performed in isolation or in conjunction with hip impingement correction surgery. After screening, 10 articles were included. The indications for AIIS decompression were recorded, and weighted mean improvements in patient-reported outcome (PRO) scores, complication rates, and revision rates were calculated. RESULTS: A total of 547 patients (311 women; 57%) were identified, with a total of 620 operative hips. The mean age was 28.42 ± 5.6 years, and the mean follow-up was 25.22 ± 11.1 months. A total of 529 hips (85%) underwent AIIS decompression, 530 hips (85%) underwent femoral osteochondroplasty, and 458 hips (74%) underwent labral repair. Of the patients, 13% underwent bilateral AIIS decompression. The mean modified Harris Hip Score improved from 61.3 ± 6.9 to 88.7 ± 4.7 postoperatively (change, 27.4 ± 5.7 points; P < .001), the Hip Outcome Score-Activities of Daily Living improved from 67.2 ± 10.6 to 91.1 ± 3.2 postoperatively (change, 24.0 ± 8.0 points; P = .001), and the Hip Outcome Score-Sports Specific Subscale improved from 36.8 ± 19.2 to 82.8 ± 3.8 postoperatively (change, 46.0 ± 18.2 points; P = .002). The pooled risk of postoperative complications was 1.1% (95% CI, 0.1%-2.1%), and the pooled risk of needing revision surgery was 1.0% (95% CI, 0.1%-2.0%). No complication was directly attributed to the AIIS decompression portion of the procedure. CONCLUSION: PROs improved significantly after hip arthroscopy with AIIS decompression, with a low risk of postoperative complications and subsequent revision surgeries. Failure to identify extra-articular sources of hip pain in outcomes of femoroacetabular impingement syndrome, including from the AIIS, could lead to poorer outcomes and future revision surgery.

The Incidence and Outcomes Following Treatment of Capsulolabral Adhesions in Hip Arthroscopy: A Systematic Review.

Background: To perform a systematic review to evaluate the incidence of capsulolabral adhesions following hip arthroscopy (HA) for femoroacetabular impingement (FAI); including risk factors and post-treatment outcomes. Methods: Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we queried PubMed, EMBASE, and Cochrane Central Register of Controlled Trials for English-language studies with minimum 6-month follow-up after primary or revision HA for FAI, which reported the incidence of capsulolabral adhesions. Potential adhesion risk factors, such as anchor type used and protocol for capsule closure, were assessed. Pre-operative and post-operative modified Harris Hip Score (mHHS) values were compared in studies that reported them. Results: Thirty-seven articles were included (24 primary HA; 13 revision HA). There were 6747 patients who underwent primary HA (6874 hips; 3005 female, 44%). The incidence of capsulolabral adhesions, confirmed surgically during revision HA, was low. Patients undergoing surgical treatment reported postoperative improvement per modified Harris Hip Scores. Data for 746 patients undergoing second revision HA (761 hips; 449 female, 60%), showed an incidence of adhesions greater than that of primary HA patients. Conclusion: While the incidence of symptomatic capsulolabral adhesions after primary hip arthroscopy is low; revision hip arthroscopy is strongly associated with adhesion development. Lysis of adhesions in primary hip arthroscopy patients reliably improved patient-reported outcomes. Level of Evidence: IV.

A Pilot Study of Nutritional Supplementation in Soft Tissue Sarcoma Patients.

Background: Wound healing is particularly important for sarcoma patients who undergo neoadjuvant radiation therapy. Previous studies have demonstrated wound complications in this population approaching 35%. With this high rate of wound healing issues, identifying treatment modalities to minimize these complications is of paramount importance. Methods: All patients with high grade bone and soft tissue sarcoma received 15 days of twice daily amino acid supplementation starting in the immediate post-operative period. We documented the healing status of the surgical wound, the primary outcome, at all follow up appointments until six months after surgery. Non-healing wounds were defined as any wound requiring 1) a return visit to the OR for debridement, 2) IV antibiotics (ABX), and 3) unhealed wounds at 6 months post-operatively.1 For each patient, we collected biometrics with lean body mass analysis at preoperative appointment, and two and six weeks postoperatively. The proportion with non-healing wounds was compared with a historical patient cohort using the chi-square test. In a subgroup of participants with body composition measurements, we also compared changes in mean fat mass, lean mass, and psoas index from pre-operative baseline to 6 months post-operative using generalized linear models. Results: A total of 33 consecutive patients were supplemented with a branched chain amino acid (BCAA) formulation. The historical cohort included 146 participants from the previous 7 years (2010-2017). 26% of patients in the historical cohort experienced wound complications compared to 30% in the supplemented group. (p=0.72) When focusing specifically on lower extremity sarcomas treated with neoadjuvant radiation therapy, 46% of patients in the supplemented group experienced wound healing complications compared to 39% in the non-supplemented group (p=0.68). BCAA supplementation was found to be protective with regards to decreasing muscle wasting with no difference in psoas index measurements throughout the study period compared to a 20% muscle loss in the historical cohort (p=0.02). Conclusion: In our limited sample size, there was no difference in wound healing complications between sarcoma patients who received postoperative BCAA supplementation compared to a historical cohort who were not supplemented. Patients who did not receive supplementation had a significant decline in post-operative psoas index following operative sarcoma removal. Level of Evidence: III.

Arthroscopic Decompression of the Anterior Inferior Iliac Spine.

Background: Pathologic contact between the femoral neck and anterior inferior iliac spine (AIIS or subspine) often occurs concomitantly with femoroacetabular impingement, contributing to hip pain and dysfunction1-4. We perform arthroscopic AIIS decompression to alleviate this source of extra-articular impingement and eliminate a potential cause of persistent pain following primary hip arthroscopy5-7. Description: After identifying abnormal AIIS morphology on preoperative false-profile radiographs and/or 3D computed tomography, we utilize a beaver blade to make a small incision in the proximal capsule and rectus femoris tendon. This peri-capsulotomy window grants access to the subspine region. We then shuttle an arthroscopic burr into place within this window and begin debriding the subspine deformity under direct visualization. Fluoroscopy is utilized intraoperatively to ensure adequate resection, using intraoperative false-profile views achieved by canting the C-arm approximately 40°. Resection is considered adequate when the AIIS deformity is no longer readily apparent on false-profile views and when intraoperative range-of-motion testing confirms no further impingement with hip hyperflexion. Alternatives: Femoroacetabular impingement can be treated nonoperatively with use of physical therapy and activity modification8; however, outcomes following nonoperative treatment are inferior to those following hip arthroscopy, according to various studies9-12. There are no known alternative treatments specific to subspine impingement. Rationale: As patients with subspine deformities progress through hip flexion, the femoral neck collides with the AIIS, limiting range of motion. As such, subspine deformities have been shown to be more common in dancers and other high-flexion athletes13,14. Additionally, studies have demonstrated that low femoral version of <5° is associated with increased contact between the distal femoral neck and the AIIS. This pathologic contact can occur even in the absence of an obvious subspine deformity15. In both of these patient populations, surgeons should have a high suspicion for subspine impingement, and a subspine decompression should be performed during hip arthroscopy in order to maximize patient outcomes. Expected Outcomes: This is a safe procedure that, if performed when indicated, can improve outcomes following primary hip arthroscopy. A recent systematic review found a pooled complication risk of 1.1%, a pooled revision risk of 1.0%, and significant postoperative improvements in patient-reported outcome measures16. Important Tips: Suspect subspine impingement in high-flexion athletes and patients with low femoral version, even in the absence of an obvious deformity.Ensure adequate visualization of the entire subspine deformity by creating a pericapsular window.Confirm thorough resection with use of fluoroscopic imaging intraoperatively, including false-profile views demonstrating absent subspine deformity. Acronyms and Abbreviations: FAI = femoroacetabular impingementAP = anteroposterior, refers to the technique used to obtain one of the pelvic radiographs3D CT = three-dimensional computed tomographyLCEA = lateral center-edge angle, a measurement used to quantify severity of hip dysplasiaOR = operating roomAlpha = alpha angle, a measurement used to measure femoral head-neck offset and assess the severity of a cam deformityIc = iliocapsularisRFd = direct head of rectus femorisRFr = reflected head of rectus femorisCap = hip capsuleGMi = gluteus minimusmHHS = modified Harris Hip ScoreHOS-ADL = Hip Outcome Score - Activities of Daily LivingHOS-SSS = Hip Outcome Score - Sports Specific Subscale.

Reliability of Multifrequency Bioelectrical Impedance Analysis to Quantify Body Composition in Patients After Musculoskeletal Trauma.

Background: Changes in body composition, especially loss of lean mass, commonly occur in the orthopedic trauma population due to physical inactivity and inadequate nutrition. The purpose of this study was to assess inter-rater and intra-rater reliability of a portable bioelectrical impedance analysis (BIA) device to measure body composition in an orthopedic trauma population after operative fracture fixation. BIA uses a weak electric current to measure impedance (resistance) in the body and uses this to calculate the components of body composition using extensively studied formulas. Methods: Twenty subjects were enrolled, up to 72 hours after operative fixation of musculoskeletal injuries and underwent body composition measurements by two independent raters. One measurement was obtained by each rater at the time of enrollment and again between 1-4 hours after the initial measurement. Reliability was assessed using intraclass correlation coefficients (ICC) and minimum detectable change (MDC) values were calculated from these results. Results: Inter-rater reliability was excellent with ICC values for body fat mass (BFM), lean body mass (LBM), skeletal muscle mass (SMM), dry lean mass (DLM), and percent body fat (PBF) of 0.993, 0.984, 0.984, 0.979, and 0.986 respectively. Intra-rater reliability was also high for BFM, LBM, SMM, DLM, and PBF, at 0.994, 0.989, 0.990, 0.983, 0.987 (rater 1) and 0.994, 0.988, 0.989, 0.985, 0.989 (rater 2). MDC values were calculated to be 4.05 kg for BFM, 4.10 kg for LBM, 2.45 kg for SMM, 1.21 kg for DLM, and 4.83% for PBF. Conclusion: Portable BIA devices are a versatile and attractive option that can reliably be used to assess body composition and changes in lean body mass in the orthopedic trauma population for both research and clinical endeavors. Level of Evidence: III.

Conditionally Essential Amino Acid Supplementation Reduces Postoperative Complications and Muscle Wasting After Fracture Fixation: A Randomized Controlled Trial.

BACKGROUND: Postoperative complications and substantial loss of physical function are common after musculoskeletal trauma. We conducted a prospective randomized controlled trial to assess the impact of conditionally essential amino acid (CEAA) supplementation on complications and skeletal muscle mass in adults after operative fixation of acute fractures. METHODS: Adults who sustained pelvic and extremity fractures that were indicated for operative fixation at a level-I trauma center were enrolled. The subjects were stratified based on injury characteristics (open fractures and/or polytrauma, fragility fractures, isolated injuries) and randomized to standard nutrition (control group) or oral CEAA supplementation twice daily for 2 weeks. Body composition (fat-free mass [FFM]) was measured at baseline and at 6 and 12 weeks postoperatively. Complications were prospectively collected. An intention-to-treat analysis was performed. The relative risk (RR) of complications for the control group relative to the CEAA group was determined, and linear mixed-effects models were used to model the relationship between CEAA supplementation and changes in FFM. RESULTS: Four hundred subjects (control group: 200; CEAA group: 200) were enrolled. The CEAA group had significantly lower overall complications than the control group (30.5% vs. 43.8%; adjusted RR = 0.71; 95% confidence interval [CI] = 0.55 to 0.92; p = 0.008). The FFM decreased significantly at 6 weeks in the control subjects (-0.9 kg, p = 0.0205), whereas the FFM was maintained at 6 weeks in the CEAA subjects (-0.33 kg, p = 0.3606). This difference in FFM was not seen at subsequent time points. CONCLUSIONS: Our results indicate that CEAA supplementation has a protective effect against common complications and early skeletal muscle wasting after operative fixation of extremity and pelvic fractures. Given the potential benefits of this inexpensive, low-risk intervention, multicenter prospective studies in focused trauma populations are warranted. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

In Situ Straightening of a Bent Tibiofemoral Intramedullary Nail: Case Report and Review of the Literature.

Background: Intramedullary nailing is considered the gold standard for the surgical management of diaphyseal long bone fractures of the lower extremity. A rare complication following intramedullary nailing of a femur or tibia fracture is periprosthetic fracture following secondary trauma with deformation of the nail itself. We present a case of a 51-year-old male with a long history of prior left knee arthrodesis with a tibiofemoral nail who sustained a work injury resulting in a proximal tibia fracture and bent tibiofemoral nail. Clinically, he presented with significant varus and procurvatum limb deformity and a six-centimeter limb length discrepancy. The patient was successfully managed with in situ straightening of the tibiofemoral nail under a general anesthetic with return to work three months following manipulation. Level of Evidence: IV.

Pharmacokinetic and Histopathologic Study of an Extended-Release, Injectable Formulation of Buprenorphine in Sprague-Dawley Rats.

A novel buprenorphine (BUP) extended-release formulation (BUP-XR) produced as a lipid-encapsulated, low viscosity BUP suspension for SC injection to control pain was evaluated for pharmacokinetics and safety in Sprague-Dawley rats given either 0.65 mg/kg (low dose) or 1.30 mg/kg (high dose). The 2 dosage groups each contained 6 male and 6 female rats to determine whether BUP-XR behaved differently in male or female animals. Blood samples were obtained from each animal before BUP-XR administration and at 6, 24, 48, 72, 96, and 168 h after administration. For necropsy and injection-site histopathology evaluation, 3 animals of each sex from each test group were euthanized on day 8, with the remaining animals euthanized on day 15. Mean plasma BUP concentration peaked from 6 to 24 h in all test groups, then declined in a linear fashion. Quantifiable plasma BUP was measured in all male rats at all time points except for one low dose group sample taken at 168 h. Female rats had quantifiable plasma BUP at all time points except for 1 low dose group sample at 72 and 96 h, and 2 low dose group samples at 168 h. The low dose groups, whether male or female, had lower mean plasma BUP levels at all time points as compared with their high dose counterparts, and female rats had lower mean plasma BUP levels than male rats at all time points. Results indicate that a single BUP-XR dose at either dose concentration can reliably provide plasma levels of BUP reported in the literature to be therapeutically relevant for up to 72 h, although lower plasma BUP levels can be anticipated in female rats compared with male counterparts. Mild to moderate injection-site granulomatous inflammation was observed in 6 of 12 rats in the low dose group and 7 of 12 in the high dose group. This reaction is characteristic of lipid material designed to persist in situ.

Interstitial duplication of 8q22.1-q23.1- A case report and review of the literature.

This report highlights the clinical features seen in duplication of 8q22.1q23.1 inherited from balanced father. It stresses the importance of obtaining a karyotype to identify the location of a large copy number variant for accurate recurrence risk estimation.

Quality management for the international transport of laboratory animals.

Increased collaboration between investigators at different institutions has increased the number of laboratory animals being transported. The current system of laws and regulations governing animal shipments is inconsistent and government agencies often have areas of overlapping regulatory management. Furthermore, the lack of industry-wide shipping standards and good practices contributes to confusion among those responsible for shipment. One answer to these quality control issues would be the establishment of independent, industry-regulated 'good practices' for animal transport, similar to those used in laboratories for experimental design. These good practices could be based on the existing International Air Transport Association Live Animals Regulations, with contributions from representatives of the specialties involved. Additionally, quality control under the current system of patchwork regulations could be improved if each institution, both academic and commercial, would designate a single point of contact to follow each shipment from start to finish.