Phase 2 study of gandotinib (LY2784544) in patients with myeloproliferative neoplasms.

BACKGROUND: The Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs) are associated with increases in janus kinase 2 (JAK2) signaling, often resulting from the JAK2 V617F mutation. LY2784544 (gandotinib) is a potent, selective, small-molecule inhibitor of JAK2 that has potential dose-dependent selectivity for the JAK2 V617F mutation and may inhibit additional JAK2 mutant isoforms in nonclinical testing. METHODS: A multicenter, single-arm, outpatient phase 2 study evaluated the efficacy, safety, and pharmacokinetics (PK) of gandotinib administered to patients (120 mg once daily) with MPNs, including polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF). Between May 2012 and March 2015, 138 patients received at least one dose of study drug. FINDINGS: Most frequent Grade 3 or 4 treatment-emergent adverse events that were considered study-drug related were anemia (11.6%), hyperuricemia (3.2%), fatigue (2.9%), diarrhea (2.2%), and thrombocytopenia (2.2%). Overall response rates (ORRs) in patients with JAK2 V617F-mutated PV, ET, and MF were 95%, 90.5%, and 9.1%, respectively, while patients with ET and MF without the JAK2 V617F mutations had ORRs of 43.7% and 0%, respectively. INTERPRETATIONS: LY2784544 demonstrated efficacy in JAK2 V617F-mutated MPNs, including in patients previously on ruxolitinib therapy, who had an ORR of 3.3%. At the 1-year visit, 44% of patients experienced a ≥50% improvement in the MPN-Symptom Assessment Form Total Symptom Score, and 26% of patients had a 50% reduction in Brief Fatigue Inventory score.

Arthroscopic decompression for impingement syndrome secondary to an unstable os acromiale.

PURPOSE: The purpose of this study was to examine cases of patients with impingement syndrome secondary to an unfused, unstable, os acromiale. TYPE OF STUDY: Retrospective case series. MATERIALS AND METHODS: Twelve consecutive patients (13 shoulders) presented with impingement symptoms in the presence of an os acromiale. The os acromiale, at the meso-acromion level, was seen on standard radiographs. The patients were all treated conservatively with rotator cuff strengthening, stretching, anti-inflammatory medications, and steroid injections. All patients underwent an impingement test with lidocaine, resulting in complete relief of their pain. After failure of the conservative management, the 12 patients (13 shoulders) underwent an extended arthroscopic subacromial decompression. The goal of the modified arthroscopic acromioplasty was resection of adequate bone to remove the mobile anterior acromial tip. In general, this consisted of more bony resection than the typical arthroscopic acromioplasty. Postoperatively, the patients began a rehabilitation program emphasizing early range of motion followed by isolated free-weight rotator cuff strengthening exercises. Five shoulders had a partial-thickness tear of the rotator cuff. Four involved less than 50% of the thickness of the rotator cuff. These 4 partial-thickness tears underwent arthroscopic rotator cuff debridement. One partial-thickness tear was greater than 50% and repair was performed with a mini-open deltoid-splitting technique. RESULTS: Results were evaluated using UCLA shoulder scoring. Preoperatively, the score averaged 17. The 3-month postoperative score was 27, and at 6 and 12 months, averaged 28. The final follow-up score averaged 31. There were 11 satisfactory results with UCLA scores >/=28. Two unsatisfactory results showed UCLA scores in the fair category. Full strength of the anterior deltoid and rotator cuff muscles was achieved in all patients by 6 months postoperatively as evaluated by manual muscle testing. Twelve of the 13 shoulders were rated by the patients as having a satisfactory result. All of the patients rated their cosmetic results as acceptable. There was no evidence of postoperative deltoid detachment. No patient developed pain at the pseudarthrosis point. CONCLUSIONS: Given the previously reported poor results with attempts at fusion of an unstable os acromiale and open complete excision of meso-acromial fragments, the authors conclude that an extended arthroscopic subacromial decompression results in a reasonable outcome for patients with impingement syndromes secondary to an unstable os acromiale.

Placental transfer of fentanyl in early human pregnancy and its detection in fetal brain.

We have investigated the transfer of fentanyl across the early human placenta in 38 women (8-14 weeks' gestation) undergoing termination of pregnancy. After administration of a bolus dose of fentanyl 2 micrograms kg-1 at induction of anaesthesia, maternal blood n = 38), placenta (n = 38), amniotic fluid (n = 38) and fetal brain (n = 7) samples were collected and assayed for fentanyl by radioimmunoassay. Fentanyl was detected in all placental and fetal brain samples but not in amniotic fluid. There was a rapid decrease in fentanyl concentrations in maternal serum after the bolus but placental concentrations had not started to decline 30 min later. There was no difference in placental drug concentrations at different gestational ages. These data suggest that there is rapid transfer of fentanyl to the fetus in early pregnancy and that the drug remains in fetal tissue for some time after the initial dose is given to the mother.

In-vivo measurement of intrauterine gases and acid-base values early in human pregnancy.

A new multiparameter sensor that combines electrochemical and fibre-optic technology was used for continuous in-vivo investigation of pH, carbon dioxide partial pressure (PCO(2)), oxygen partial pressure (PO(2)), bicarbonate concentration (HCO(3)(-)), base excess, and oxygen saturation (O(2)Sat) early in human pregnancy. The sensor was inserted into the amniotic cavity and the placental bed of 16 pregnancies at 10-15 weeks gestation, before termination under general anaesthesia. Amniotic fluid and retroplacental blood from the same site were also aspirated and analysed by means of cartridges and a portable blood gas analyser. Eleven series of measurements were obtained. The variation in measurements over the 5 min of monitoring was

Light-chain paraproteins with lupus anticoagulant activity.

A patient with newly diagnosed multiple myeloma manifested by urine kappa light-chain excretion and a small monoclonal spike (0.4 g/dl), presented with lower extremity deep venous thrombosis. A preheparin plasma-activated partial thromboplastin time (aPTT) was prolonged at 68 sec (normal control 26-42 sec). Additional studies confirmed the presence of lupus anticoagulant activity in the serum: the modified Russell Viper Venom Time (MRVVT) was 73 sec (normal control 24-42 sec) and with a 50:50 mix of the patient's plasma and pooled normal plasma, the MRVVT remained prolonged. Kappa light chains (LC) were isolated from the patient's urine and their purity confirmed by electrophoresis and immunofixation using specific immunoglobulin antisera. The patient's LC mixed with pooled normal plasma demonstrated LA activity by in vitro clotting tests (plasma-activated partial thromboplastin time 62 sec, with normal control of 45 sec), MRVVT of 44 sec with normal control of 35 sec. Purified urinary kappa light chains from a control patient with multiple myeloma and normal clotting studies, failed to prolong either the plasma-activated partial thromboplastin time or the MRVVT. We hypothesize that kappa LC in our patient demonstrated LA activity, which was unique to these LCs. Paraproteins with LA activity, to date, have included only intact immunoglobulins (Ig). While intact Ig paraproteins have been reported to possess LA activity, this is the first report to our knowledge of light-chain paraproteins possessing similar activity and resulting in clinically evident thrombosis. Light chain paraproteins could serve as useful models for further study of the mechanisms of activity of acquired LA inhibitors.

Cost-benefit comparison: holmium laser versus electrocautery in arthroscopic acromioplasty.

This prospective study was designed to measure the costs and benefits of using a laser rather than electrocautery for soft tissue resection during arthroscopic shoulder decompression. Forty-nine shoulders with refractory Neer stage II impingement (persistent fibrosis and tendinitis) were divided into 2 groups. The composition of the 2 groups was similar with regard to sex, worker's compensation status, dominant arm involvement, duration of symptoms, and length of conservative treatment. In one group, electrocautery was used to ablate the bursa and periosteum, release the coracoacromial ligament, and maintain hemostasis. In the other group, a laser was used in place of electrocautery. Patients had been evaluated preoperatively with 2 functional scoring systems. The patients were reexamined at 1 week and at 1, 2, 3, 6, and 12 months after surgery. There were no differences between the groups with regard to functional outcome or satisfaction. There was also no difference in terms of estimated blood loss or operative time. However, there was a statistically significant difference in total hospital charges between groups, with the laser group having a 23% higher hospital bill. On the basis of these results, it is concluded that there was no medical benefit to laser-assisted arthroscopic subacromial decompression but there was an increased monetary cost.

Use of in vitro data for construction of a physiologically based pharmacokinetic model for naphthalene in rats and mice to probe species differences.

A physiologically based pharmacokinetic (PBPK) model with five tissue groups (lung, liver, fat, richly perfused, and poorly perfused tissues plus venous and arterial blood compartments) has been developed from in vitro data and models of primary cell cultures for naphthalene toxicity in mice and rats. It extends a previous naphthalene PBPK model (Sweeney et al., 1996) and demonstrates a possible approach to a predictive mathematical model that requires minimal animal data. Naphthalene metabolism was examined after four exposure routes (intraperitoneal injection (ip), intravenous injection (iv), ingestion (po), and inhalation). Naphthalene and its primary metabolite, naphthalene oxide, are consumed by enzymes in pulmonary and hepatic tissues (cytochrome P450 monooxygenases, epoxide hydrolase, and glutathione-S-transferase). Additionally, the nonenzymatic reactions of naphthalene oxide in all tissues and in blood are included in the model. Kinetic constants for the model were derived primarily from cell fraction and primary cell culture incubations presented in the literature. The mouse model accurately predicts glutathione (GSH) and covalent naphthalene oxide-protein binding levels after a range of ip doses, and the rat model provides excellent estimates for mercapturate excretion following po doses; but neither model simulates well naphthalene blood concentrations after low iv doses. Good prediction of in vivo response using only in vitro data for parameter estimation (except for epoxide-protein binding rates) suggests that the assumed molecular description is a plausible representation of the underlying mechanisms of toxicity. Mice and rats show significant species differences in response to naphthalene. The model results suggest that species differences in toxicity may be explained, in part, by the lower overall rate of enzyme activities in the rat cells. Lower enzyme activities in the rat result in out-of-phase GSH minima in hepatic and lung compartments, while the simultaneous occurrence of these minima in mice results in higher naphthalene oxide concentrations, thereby allowing formation of more metabolites (e.g., covalent binding to proteins) that may be toxic.

A comparison of the vasodilatation produced by two topical anaesthetics.

The vasoactive properties of EMLA (eutectic mixture of local anaesthetic) and amethocaine were compared using Doppler colour ultrasound to measure vein diameter in 20 male volunteers. EMLA or amethocaine cream were applied over veins on the dorsum of the hand and vein diameter was measured prior to application of the preparations and at 1, 1.5 and 2 h after removal. Visual analogue scores for skin colour and vasodilatation were performed at 1 h. The results showed no significant difference in vein diameter between the EMLA and amethocaine groups. However, the amethocaine-treated hands were significantly more erythematous at 1 h (p < 0.00002).

Acute mitral valve regurgitation created in sheep using echocardiographic guidance.

BACKGROUND AND AIM OF STUDY: This study was designed to determine: (i) Whether acute mitral valve regurgitation (MVR) due to chordal rupture can be reproducibly created under echocardiographic guidance; (ii) what degree of MVR can be created; (iii) what degree of acute regurgitation is survivable; and (iv) whether acute MVR due to chordal rupture progresses over time. METHODS: In a pilot group of six juvenile farm-bred sheep, selected chordae tendineae were ruptured using either a biopsy needle or endoscopic scissors under echocardiographic guidance, without need for cardiopulmonary bypass. Sheep were sacrificed acutely (n = 2), and at six weeks (n = 2) or eight weeks (n = 2). When the technique was optimized, five sheep entered a study group in which chords were ruptured using endoscopic scissors; the sheep were sacrificed 16 weeks after surgery. RESULTS: In the pilot study, acute MVR (grade 2-4+) was produced in all sheep, normal ventricular wall motion was maintained, with minimal progression of regurgitation over time. In one pilot sheep which did not survive, grade 4+ MVR was created acutely. Use of endoscopic scissors was preferable to the biopsy needle. In the study group, acute MVR (grade 2-4+) was produced in all five sheep, and was still present at 16 weeks, with progression in only one animal. CONCLUSIONS: This pilot study demonstrated that controlled degrees of survivable acute MVR due to chordal rupture can be created under echocardiographic guidance, with minimal progression of MVR over time. This animal model can be applied to investigate the pathogenesis of clinical MVR, and to suggest appropriate medical or surgical intervention.

Complete development of the porcine coccidium Isospora suis Biester, 1934 in cell cultures.

Development from inoculated sporozoites to unsporulated oocysts of Isospora suis Biester, 1934 is described in a swine testicular (ST) cell line. Sporozoites penetrated ST cells within 1 hr postinoculation (PI). Development was initially by endodyogeny to produce binucleate type I meronts and type I merozoites. Division by endodyogeny continued during the 13-day observation period and type I merozoites were the developmental stages most abundant at observation periods >3 days PI. Mutinucleate type II meronts and type II merozoites were first observed 7 days PI. Gamonts and oocysts were present 12 days PI. Oocysts did not sporulate in vitro. The ultrastructural features of stages were similar to those that occur in the pig host.

Home based rehabilitation for anterior cruciate ligament reconstruction.

Fifty-four patients who underwent arthroscopically assisted anterior cruciate ligament reconstruction with bone-patellar tendon-bone autograft or allograft were studied prospectively to compare a postoperative home based rehabilitation program with a clinic based program. Fifty-four patients (mean age, 30 years) were assigned randomly to the home based program (27 patients) or the clinic based program (27 patients). The home based schedule featured six physical therapy visits during a 6-month postoperative study period, whereas the clinic based schedule specified 24 physical therapy visits during those 6 months. All patients entered in the study met strict selection criteria: age older than 15 years, no previous ligament repair or reconstruction, no complicating medical conditions, no collegiate or professional athletes, reconstruction at least 6 weeks after injury, and informed consent. At the 6-month followup, no significant statistical differences were found between the two groups in range of motion, thigh atrophy, anterior drawer compliance, hopping tests, Lysholm scores, or subjective health status scores. Thus, the authors conclude that in a selected group of patients who have undergone anterior cruciate ligament reconstruction, a home based postoperative rehabilitation program is feasible, safe, and effective.

Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial.

PURPOSE: To evaluate the effectiveness and safety of samarium-153 (153Sm) lexidronam (EDTMP) in a double-blind, placebo-controlled study. PATIENTS AND METHODS: Patients with painful bone metastases secondary to a variety of primary malignancies were randomized to receive 153Sm-EDTMP 0.5 or 1.0 mCi/kg, or placebo. Treatment was unblinded for patients who did not respond by week 4, with those who had received placebo eligible to receive 1.0 mCi/kg of active drug in an open-label manner. Patient and physician evaluations were used to assess pain relief, as was concurrent change in opioid analgesia. RESULTS: One hundred eighteen patients were enrolled onto the study. Patients who received 1.0 mCi/kg of active drug had significant reductions in pain during each of the first 4 weeks in both patient-rated and physician-rated evaluations. Pain relief was observed in 62% to 72% of those who received the 1.O-mCi/kg dose during the first 4 weeks, with marked or complete relief noted in 31% by week 4. Persistence of pain relief was seen through week 16 in 43% of patients who received 1.0 mCi/kg, of active drug. A significant correlation (P = .01) was observed between reductions in opioid analgesic use and pain scores only for those patients who received 1.0 mCi/kg 153Sm-EDTMP. Bone marrow suppression was mild, reversible, and not associated with grade 4 toxicity. CONCLUSION: A single dose of 1.0 mCi/kg of 153Sm-EDTMP provided relief from pain associated with bone metastases. Pain relief was observed within 1 week of administration and persisted until at least week 16 in the majority of patients who responded.

Altered collagen concentration in mitral valve leaflets: biochemical and finite element analysis.

BACKGROUND: Ischemic mitral regurgitation or ventricular wall motion abnormalities will alter the stress distribution in the mitral valve. We hypothesize that in response, the regional collagen concentration will be altered and will significantly impact the stress distribution in the mitral valve. METHODS: Two sheep served as normal (sham) controls. Two other sheep had coronary ligation resulting in abnormal ventricular wall motion. Four sheep underwent ligation to infarct the posteromedial papillary muscle, resulting in ischemic regurgitation. After 4 or 8 weeks, the mitral valves were excised, and the anterior leaflet sections were subjected to an assay for collagen concentration. Next, in a finite element model, to simulate changes in collagen concentration, the tissue stiffness was increased by 20%, and then decreased by 20%. In another model, the thickness of the tissue was increased by 20%, and then combined with decreased tissue stiffness. Physiologic loading pressures were applied, and leaflet stress, chordal stress, and coaptation results were analyzed. RESULTS: The average collagen concentration in the normal sheep leaflets was 59.2% (dry weight), 50.6% in the ischemic controls, and 45.8% in the papillary muscle infarct group. Collagen concentration was greatest at the midline and decreased toward the commissures. Increased tissue stiffness resulted in increased leaflet and chordal stresses, as well as reduced coaptation. Decreased stiffness resulted in the opposite. Increased tissue thickness reduced leaflet and chordal stresses, but also reduced coaptation. The combination of increased tissue thickness and decreased stiffness demonstrated the greatest reduction in leaflet and chordal stress, while maintaining normal leaflet coaptation. CONCLUSIONS: The observed changes may demonstrate an early effort to compensate for increased leaflet stress. Microstructural alterations may demonstrate an early effort to compensate for altered physiologic loading to reduce stress and maintain coaptation. It is crucial in repairing or partially replacing thickened tissue that normal geometry and physiology be restored.

Suprascapular nerve entrapment caused by supraglenoid cyst compression.

Twenty-two cases of suprascapular nerve entrapment caused by supraglenoid cyst compression were reviewed. Pain and weakness were the presenting symptoms in 14 shoulders and pain alone in 8. Twenty of the cysts were diagnosed by magnetic resonance imaging, and two were confirmed at surgical exploration. Electromyography of 20 shoulders was positive for neurologic involvement for both the infraspinatus and supraspinatus in 4 cases, for the infraspinatus only in 12, and negative in 4. Sixteen shoulders were treated by open excision, arthroscopy, or both. Superior labral lesions were diagnosed in 11 of 12 patients who underwent arthroscopy. At follow-up 10 of the patients who underwent surgery had complete resolution of symptoms, 5 had occasional pain or weakness, and 1 recurrence required a second surgery. Of six patients treated without surgery, two improved and four had no change. Supraglenoid ganglion cysts are common and can easily be diagnosed by magnetic resonance imaging. For patients with symptoms arthroscopy with repair of the superior labral lesion and either arthroscopic debridement or direct open decompression and excision of the cyst is recommended.

Collagen synthesis is upregulated in mitral valves subjected to altered stress.

Mitral regurgitation (MR) and abnormal ventricular wall motion (AVWM) are two cardiac conditions that may increase mitral valve (MV) stresses. Theoretically, increased stress could induce damaging MV tissue alterations. These alterations may impair the preferred option of repair, and mandate replacement. It is hypothesized that MV collagen synthesis is upregulated in response to MR and AVWM. To test this hypothesis in a pilot study, an ischemic sheep model (n = 8) was employed. Four sheep underwent selective coronary artery ligation to infarct a papillary muscle, which resulted in MR. Two other sheep underwent similar coronary ligation to create AVWM. As controls, two sheep underwent sham surgery (no ligation). Sheep were killed 4 and 8 weeks post operatively and their MVs were sectioned. Sections were stained with an antibody (SP1.D8, University of Iowa) to procollagen I (precursor to collagen I). The percent area of procollagen stain present present was measured by image analysis (Optimas Corporation) and used as an indicator of collagen synthesis. Procollagen results indicated that MV collagen synthesis was upregulated by factor of 1.8 in both the MR and AVWM groups versus controls. In addition, results showed greater upregulation in anterior leaflets compared with posterior leaflets in both infarct groups. These results indicate that MV collagen synthesis is upregulated in response to MR and AVWM.

Joint pain and weather. A critical review of the literature.

Many people believe that weather conditions can influence joint pain, but science offers no proof. If the phenomenon were real, cause-and-effect mechanisms might provide clues that would aid joint pain treatment. Literature on the subject is sparse, conflicting, and vulnerable to bias, and further physiologic investigations are not likely to produce useful information. However, for patients who believe that weather can influence their pain, the causes may be unknown, but the effect is real.

Chronically injured posterior cruciate ligament: magnetic resonance imaging.

Magnetic resonance imaging has been said to be highly reliable for diagnosis of acute posterior cruciate ligament insufficiency. In the present study, 13 patients whose posterior cruciate ligament insufficiency had been documented by magnetic resonance imaging within 10 weeks of the acute injury were recalled for a followup examination and magnetic resonance imaging. The followup interval ranged from 5 months to 4 years. In only 23% of the cases did the posterior cruciate ligament still appear discontinuous on followup magnetic resonance imaging. In the remaining 77%, the posterior cruciate ligament was continuous from tibia to femur, although it appeared abnormally arcuate or hyperbuckled. Conventional interpretation of these magnetic resonance images would suggest that the posterior cruciate ligament had healed. Nevertheless, by clinical examination results, these same patients all were judged to have posterior cruciate ligament insufficiency. Thus, it was concluded that although magnetic resonance imaging may be reliable for evaluation of acute posterior cruciate ligament injury, magnetic resonance imaging findings should not be used to infer functional status in chronic cases.

A self-regulating cell culture analog device to mimic animal and human toxicological responses.

The overall goal of this project is the development of a new methodology for translating advances in molecular level understanding of toxicological responses into a predictive tool for dose response in whole animals and humans exposed to single compounds or mixtures of compounds. The methodology incorporates a mechanistic cellular level model into a PBPK (physiologically based pharmacokinetic) model which simultaneously guides the development of an in vitro cell culture analog (CCA) to the PBPK. Where the PBPK specifies an organ, (e.g., liver) the in vitro or CCA system contains a compartment with the appropriate cell or cell population (e.g., hepatocytes for the liver). The CCA has significant advantages over other in vitro systems and PBPK systems used independently for evaluating metabolic responses to drugs or potentially toxic chemicals where the exchange of metabolites between organs is likely to be important. The CCA system is superior to a PBPK because an a priori description of complete metabolism is not required and secondary, unexpected interactions can be detected. The CCA system, unlike other in vitro systems, gives a dynamic response that realistically simulates in vivo interactions between organs. Furthermore, the CCA allows dosing on the same basis as animal tests (e.g., milligrams per kilogram of body mass equivalent). Because the construction of a CCA is guided by a PBPK, this approach allows extrapolation to low doses and across species, including extrapolation to humans. We have constructed a prototype system and have conducted proof-of-concept experiments using naphthalene as a test chemical. These experiments clearly demonstrate the ability to generate a reactive metabolite in one compartment and detect its effects (on LDH release and glutathione depletion) in a second compartment. However, this prototype device would be expensive to replicate and requires nearly constant supervision from a trained investigator. For this concept to replace animals an inexpensive, self-regulating device is needed. An initial design to accomplish this goal is described as well as the corresponding model using naphthalene as a test compound. (c) 1996 John Wiley & Sons, Inc.

Randomized placebo-controlled trial of granulocyte-macrophage colony-stimulating-factor support for dose-intensive cyclophosphamide, etoposide, and cisplatin.

This is a double-blind randomized placebo-controlled trial to evaluate the efficacy and safety of granulocyte-macrophage colony-stimulating-factor (GM-CSF) after dose-intensive cyclophosphamide, etoposide, and cisplatin (DICEP). Fifty-six patients with lymphoma or breast carcinoma were randomized to receive GM-CSF 250 microg/m2 or placebo subcutaneously (SC) every 12 hr after each course of DICEP until recovery of absolute neutrophil count (ANC) of 1.5 x 10(9)/L. Each patient was to receive three courses of DICEP. There were 28 patients in each group. The median duration of ANC below 0.5 x 10(9)/L was 10 versus 12 days for Course 1 (P = 0.010), 10 versus 12 days for Course 2 (P = 0.248), and 16.5 versus 15 days for Course 3 (P = 0.126); platelet counts below 20 x 10(9)/L was 4 versus 4 days for Course 1 (P = 0.586), 8.5 versus 7 days for Course 2 (P = 0.013), and 23.5 versus 10.5 days for Course 3 (P = 0.104); hospitalization for patients readmitted with cytopenic fever were 4 versus 8 days for Course 1 (P = 0.035); 7 versus 6 days for Course 2 (P = 0.692); and 8 versus 12 days for Course 3 (P = 0.884) in the GM-CSF and placebo group, respectively. GM-CSF significantly shortens the duration of neutropenia and readmission only during the first course of DICEP. There was a delay in platelet recovery and an increase in transfusion requirement during subsequent courses in the GM-CSF group. The result cautions the routine use of lineage specific hematopoietic growth factors in supporting repeated cycles of dose-intensive chemotherapy.

Arthroscopic versus open reconstruction of the shoulder in patients with isolated Bankart lesions.

We compared open and arthroscopic stabilizations of true Bankart lesions in patients with traumatic, unidirectional anterior glenohumeral dislocations. The 27 patients were men (age range, 18 to 56 years) who were involved in recreational sports. One group (15 patients) had elected an arthroscopic Bankart repair; the other group (12 patients) had chosen open stabilization with a standard deltopectoral approach. Patients were followed up 17 to 42 months after surgery by examination, radiographs, and interviews. In the open repair group, 1 of the 12 patients experienced a subluxation in the follow-up period, but no patients had dislocations or reoperations. In the arthroscopic group, 5 of 15 patients had experienced subluxation or dislocation; of these 5 patients, 2 underwent reoperation. The arthroscopic group had significantly worse results in satisfaction, stability, apprehension, and loss of forward flexion in the operated limb. In summary, the arthroscopic procedure did not significantly improve function; instead, it produced an increased failure rate compared with the open procedure. Therefore, we believe that open stabilization remains the procedure of choice for patients with true Bankart lesions.