Juvenile hallux valgus: Comparison of three types of osteotomy and medium-term postoperative results.

BACKGROUND: There is no consensus on the treatment of juvenile hallux valgus (JHV). Numerous surgical techniques have been described, none of which has been proven to be superior and the mid-term results of these methods are not well known. Our objective was to compare the mid-term clinical, radiographic, and functional results of three metatarsal osteotomy techniques. METHODS: Patients under 18 years of age operated on for JHV between January 2010 and December 2019 were included in this multicenter retrospective study. Patients were excluded if they had non-idiopathic hallux valgus or if their postoperative follow-up was less than 3 years. The surgical techniques used were metatarsal osteotomies: basimetatarsal, scarf, or distal. During follow-up visits, we collected HMIS-AOFAS (Hallux Metatarsophalangeal Interphalangeal Scale-American Orthopedic Foot and Ankle Society) and Visual Analogue Scale (VAS) scores, acquired radiographs, and recorded complications and recurrences. Secondarily, the study population was stratified according to physis status (open vs. closed). RESULTS: During the study period, 18 patients (26 feet) met the inclusion criteria. The median postoperative follow-up was 6.5 (4.1) years. At the end of follow-up, the median HMIS score was 79.0 (20.0), the mean hallux valgus angle (HVA) improvement was 13.2° (16.8), and the complication and recurrence rates were 31 % and 23 %, respectively. There was no significant difference in the outcome measures between the three techniques or any difference according to physis status at the time of surgery. DISCUSSION AND CONCLUSION: The functional and radiographic results of metatarsal osteotomies are good in the medium term, regardless of the osteotomy site. Our results are comparable to those published in the literature. As our sample size was limited, it did not lead to the identification of statistically significant differences.

Neuromonitoring for spine surgery in children.

Neuromonitoring or electrophysiologic monitoring is now an essential component of pediatric spine surgery due to the high number of spinal deformity indications in asymptomatic patients, for whom any neurological complication would be disastrous. Technological advances have led to the development of compact monitors that allow surgeons themselves to monitor the motor evoked potentials (MEP) perioperatively. This shift happened because it was difficult to always have a neurophysiologist in the operating room. Unfortunately, this also means that multimodal monitoring (sensory, mixed, D-wave, electromyography, pedicle screws) is much more difficult to implement. There are absolute indications, such as any spinal deformity without neurological deficit and relative indications, which are more difficult to interpret. Technical incidents frequently occur before the start of the surgery. If no replacement device is available, the procedure must be cancelled unless the patient's life or function are at risk. At least two monitoring systems should be available at every facility to avoid having to cancel surgery for purely technological reasons. Once the surgical procedure has started, the absence of MEP recruitment curves in the upper and lower limbs is likely due to the anesthesia depth; the surgery should be stopped until this problem is corrected. When there is a true intraoperative alert (MEPs disappear in the lower limbs only), we propose taking the following steps, depending on whether the spine is stable or unstable: remove the causal implant, remove all hardware, preserve any stabilization devices, initiate an intraoperative wake-up test, verify conditions under which the intervention should continue. Level of evidence: V.

Tibia Valga Correction by Extraperiosteal Fibular Release in Multiple Exostosis Disease.

Genu valgum is a frequent deformity encountered in Multiple Hereditary Exostosis (MHE) patients. If left untreated, lower limb deformity leads to poor functional outcomes in adulthood. Our hypothesis was that in some cases, fibular shortening would lead to a lateral epiphysiodesis-like effect on the tibia. We herein report the case of a 6-year-old child with MHE who underwent extraperiosteal resection of the fibula for tibia valga correction. To obtain the lateral release of the calf skeleton, resection included inter-tibio-fibular exostosis along with proximal fibular metaphysis and diaphysis without any osseous procedure on the tibia. Gradual improvement of the valgus deformity occurred during follow-up (HKA from 165° preop to 178° at 27-month follow-up). Lateral release of the fibula led to an increase in the fibula/tibia index (from 93% preop to 96% at follow-up). Studying fibular growth in MHE patients could help understand how valgus deformity occurs in these patients. Even if encouraging, this result is just the report of a unique case. Further research and a larger series of patients are required to assess fibular release as a valuable option to treat valgus deformity in MHE.

Clinical and radiographic evolution of graduate patients treated with magnetically controlled growing rods: results of a French multicentre study of 90 patients.

PURPOSE: The purpose of this study was to investigate patients with early-onset scoliosis (EOS) who completed their electromagnetic lengthening rod program to assess the demographics of this population and to analyze the evolution of clinical and radiological parameters and the occurrence of complications. METHODS: This was a multicenter study with 10 French centers. We collected all patients with EOS who had undergone electromagnetic lengthening between 2011 and 2022. They had to have reached the end of the procedure (graduate). RESULTS: A total of 90 graduate patients were included. The mean follow-up time over the entire period was 66 months (25.3-109). Of these, only 66 patients (73.3%) underwent definitive spinal arthrodesis at the end of the lengthening phase, whereas 24 patients (26.7%) kept their hardware in situ with a mean follow-up time from the last lengthening of 25 months (3-68). Patients had an average of 2.6 surgeries (1-5) over the entire follow-up. Patients had an average of 7.9 lengthenings for a mean total lengthening of 26.9 mm (4-75). Analysis of the radiological parameters showed a percentage reduction in the main curve of 12 to 40%, depending on the etiology, with an average reduction of 73-44°, and an average thoracic height of 210 mm (171-214) for an average improvement of 31 mm (23-43). There was no significant difference in the sagittal parameters. During the lengthening phase, there were a total of 56 complications in 43 patients (43.9%; n = 56/98), of which 39 in 28 patients (28.6%) resulted in unplanned surgery. In the graduate patients, there were a total of 26 complications in 20 patients (22.2%), all of which resulted in unscheduled surgery. CONCLUSION: MCGR, allow to decrease the number of surgeries, to progressively improve the scoliotic deformity and to reach a satisfactory thoracic height at the price of an important complication rate linked in particular to the complexity of the management of patients with an EOS.

Athletic children: Guidelines and monitoring in pediatric orthopedic surgery.

In day-to-day practice pediatric orthopedic surgeons often come up against the question of sport. The aim of the present study was to analyze the relationship between sport and childhood, with 3 questions: (1) What are the benefits of sport for children? (2) How to manage high-level child athletes? And (3) What sports are possible after major orthopedic surgery? Sports provide many benefits for children, and are to be encouraged. Sixty minutes' moderate to intense physical activity per day benefits motor development and bone mineralization and reduces the risk of obesity. On the other hand, excessive sports activity, as encountered in high-level sport, can be harmful for the child's development. The amount of training should not exceed a certain threshold in terms of hours per week according to age. Surgical treatment of sport-related traumatic lesions does not necessarily accelerate return to sport: indications need to be reasonable, despite pressure from the patient's circle. Sports are possible after major orthopedic surgery, although return to sport tends to be delayed and the level is lower than preoperatively.

How does magnetically controlled growing rods insertion affect sagittal alignment in ambulatory early onset scoliosis patients?

PURPOSE: The importance of sagittal alignment restoration in early onset scoliosis (EOS) management has rarely been investigated to date. The aim was to report the influence of magnetically controlled growing rods (MCGR) insertion on the sagittal alignment of EOS patients. METHODS: All consecutive ambulatory patients operated with MCGR rods between 2011 and 2018 were retrospectively included in four institutions. Standing biplanar radiographs were performed preoperatively, in the early postoperative period and at latest follow-up. Global and local sagittal parameters, spinal global shape and harmony were investigated. RESULTS: A total of 37 ambulatory EOS patients were included (mean age at surgery 8.5 (± 2) years). 70% had a balanced construct postoperatively. Both MaxTK (- 17°, p = 0.02) and MaxLL (- 15°, p = 0.001) were significantly reduced, particularly at the instrumented levels. The number of vertebrae included in the lumbar lordosis significantly increased (+ 2 levels, p = 0.02), as well as the thoraco-lumbar inflexion point (+ 2 levels, p < 0.001) and the kyphosis apex (+ 1 level, p < 0.001). Overall mechanical failure rate was 40.5%, and radiological PJK was observed in 43% of the patients, with 11 remaining asymptomatic. Patients with initial hyperkyphosis (> 50°) developed more complications (62% vs. 28%, p = 0.04). CONCLUSION: MCGR insertion flattened the spine in EOS, at both instrumented and non-instrumented levels. Overall spinal harmony was modified, with a cranial shift of the thoraco-lumbar inflexion point and the thoracic kyphosis apex, associated with a lengthening of the lumbar lordosis. The rate of complication remained high, some explanations being found in the radiological changes reported such as the preoperative location of the TK apex. LEVEL OF EVIDENCE: IV.

Treatment of knee sprains in children.

The incidence of knee sprains in children is steadily increasing. Skeletal immaturity and anatomical features of the child's ligamentous structures explain the frequency of bone avulsions in young children. Peripheral ligament injuries are the most common and often benign. Nevertheless, associated injuries of the cruciate or patellofemoral ligament(s) are not rare and must not be missed. Age is a determining factor in diagnostic guidance. Anterior intercondylar tibial eminence fractures, otherwise known as tibial spine fractures (TSF), usually occur in young children. Ligamentous distension at the time of the accident would explain the residual laxity that can affect the prognosis of these fractures. The treatment of interstitial ruptures of the ACL follows recommendations that are becoming clearer through multicentric studies. Reparation techniques, historically rejected as ineffective, have again become topical under specific conditions with the aim of preserving the native ACL and its proprioceptive receptors, which are essential in children. ACL reconstruction techniques have made progress in children, especially with techniques adapted from adults. Preservation of growth plates remains pertinent, especially at the femur to avoid growth disorders, thus highlighting the important role paediatric orthopaedic surgeons have in the management of these knee sprains.

Epidemiology of spinal fractures in children: Cross-sectional study.

INTRODUCTION: Epidemiological studies of fractures of the spine in children are all old, mostly single-centre, with series spanning periods of 5 to 20 years. HYPOTHESIS: As lifestyle is constantly changing, notably with an increase in sports activities and improvements in the prevention of road and household accidents, epidemiology has likely changed. OBJECTIVE: To update the description of spinal trauma in children and adolescents compared to the existing literature. MATERIAL AND METHOD: A multicentre cross-sectional study of spinal fracture, dislocation and spinal cord injury without radiological abnormality (SCIWORA) in children was carried out in 15 French university hospital centres, for a period of one year (2016). RESULTS: One hundred and sixty-five children were identified: 85 girls, 80 boys; mean age 11 years (range, 10 months-17 years); median, 12 years 6 months. One hundred and fifty-two children (92%) had fracture, 8 (5%) dislocation (including 7 C1-C2 rotary dislocations), and 5 (3%) SCIWORA. Fractures were multiple in 80 cases (49%), contiguous in 73 cases (91%) and non-contiguous in 7 (9%). Locations were cervical in 25 cases (15%), thoracic in 85 (52%), lumbar in 75 and sacral in 4 (2%). Fracture types comprised 234 vertebral compactions (78%), 25 burst fractures (8%), 5 chance fractures (2%), 2 odontoid fractures, and 33 other lesions. Causes comprised fall in 77 cases (47%), sports accidents in 56 (34%), road accidents in 29 (18%), and others in 3. In 52 cases (32%), there was ≥1 associated lesion: appendicular in 35 cases (67%), thoracic or abdominal in 31 (60%), and head in 16 (31%). Twenty-one cases had multiple lesions (40%). Eighteen cases showed neurological involvement (11%) including 5 SCIWORAs. Neurological complications were more frequent before 9 years of age. CONCLUSION: The epidemiology of spine fractures in children has slightly changed. There are now fewer cervical lesions. Causes are less often road accidents and more often sports accidents. Multi-level lesions remain frequent and the rate of neurological complications is around 10%. Compaction fracture is the most common type.

Deformity correction in thoracic adolescent idiopathic scoliosis.

AIMS: To compare the rates of sagittal and coronal correction for all-pedicle screw instrumentation and hybrid instrumentation using sublaminar bands in the treatment of thoracic adolescent idiopathic scoliosis (AIS). METHODS: We retrospectively reviewed the medical records of 124 patients who had undergone surgery in two centres for the correction of Lenke 1 or 2 AIS. Radiological evaluation was carried out preoperatively, in the early postoperative phase, and at two-year follow-up. Parameters measured included coronal Cobb angles and thoracic kyphosis. Postoperative alignment was compared after matching the cohorts by preoperative coronal Cobb angle, thoracic kyphosis, lumbar lordosis, and pelvic incidence. RESULTS: A total of 179 patients were available for analysis. After matching, 124 patients remained (62 in each cohort). Restoration of thoracic kyphosis was significantly better in the sublaminar band group than in the pedicle screw group (from 23.7° to 27.5° to 34.0° versus 23.9° to 18.7° to 21.5°; all p < 0.001). When the preoperative thoracic kyphosis was less than 20°, sublaminar bands achieved a normal postoperative thoracic kyphosis, whereas pedicle screws did not. In the coronal plane, pedicle screws resulted in a significantly better correction than sublaminar bands at final follow-up (73.0% versus 59.7%; p < 0.001). CONCLUSION: This is the first study to compare sublaminar bands and pedicle screws for the correction of a thoracic AIS. We have shown that pedicle screws give a good coronal correction which is maintained at two-year follow-up. Conversely, sublaminar bands restore the thoracic kyphosis better while pedicle screws are associated with a flattening of the thoracic spine. In patients with preoperative hypokyphosis, sublaminar bands should be used to restore a proper sagittal profile. Cite this article: Bone Joint J 2020;102-B(3):376-382.

Outcomes and Impact of a Universal COVID-19 Screening Protocol for Asymptomatic Oncology Patients.

INTRODUCTION: COVID-19 has become a serious hazard worldwide in a relatively short time. Scientific evidence supports that cancer patients infected with COVID-19 had a higher risk of developing severe complications. COVID-19 patients can be asymptomatic during part or all of their disease course, therefore it is a compelling need to develop universal pre-interventional COVID-19 screening guidelines. The aim of this study is to is review COVID-19 positive rate among asymptomatic cancer patients since the implementation of universal policy at our institution, and assess the impact of diagnosing COVID-19 on delay of oncologic interventions. MATERIALS AND METHODS: The study population comprised of all cancer patients planned for high risk interventions between April 1, 2020 - May 14, 2020 at Cleveland Clinic Abu Dhabi [CCAD] after implementing universal COVID-19 screening policy. DISCUSSION: Nosocomial transmission of COVID-19 among cancer patients could result in poor outcomes. Universal screening for high-risk populations may facilitate earlier diagnosis of COVID-19 and implementation of control strategies. Our review demonstrated that [7.5%] of asymptomatic cancer patients tested positive for COVID-19 after implementation of universal prospective screening policy. The overall evidence supporting universal COVID-19 screening of cancer patients is limited, yet as tests become more widely available, it may be reasonable to screen all cancer patients for COVID-19 before anticancer therapies. While such policy may delay and affect the timing of anticancer therapy as shown in this report, it should improve the safety of care for oncology patients and help protect healthcare workers. CONCLUSION: COVID-19 infection rate is higher in cancer patients than general population and can present without symptoms. Universal COVID-19 screening of cancer patients before high risk interventions is supported by the present findings.

Medial patellofemoral ligament reconstruction in children: do osseous abnormalities matter?

PURPOSE: Management of post-traumatic patellar instability in children with osseous abnormalities is challenging because of the presence of an open physis. The aim of our study was to compare the rate of recurrence after isolated reconstruction of the medial patellofemoral ligament (MPFL) in children with or without osseous abnormalities. METHODS: The medical records of 25 children (27 knees) with recurrent patellar dislocation were reviewed. Each child underwent an isolated reconstruction of the MPFL using a hamstring graft. At the last follow-up, a clinical and radiographic evaluation was performed, including assessment of functional outcomes based on the Kujala score. Patients were compared in terms of the occurrence of a pre-existing osseous abnormality. RESULTS: The mean age at the time of the surgery was 13.8 years. Eleven patients had trochlear dysplasia (40%), three had a patella alta (11%) and seven had an increased TT-TG (26%). The recurrence rate was 3.7% (one patient), after a mean follow-up of 41.1 months. Recurrence was not more frequent in patients with preoperative anatomical predisposing factors. The mean Kujala score was 95. The mean time to return to practicing sports was 7.1 months. CONCLUSIONS: Isolated MPFL reconstruction is an effective option for the management of post-traumatic patellofemoral instability in skeletally immature patients. The results of this technique seem to be independent on either proximal or distal misalignments such as trochlear dysplasia, patella alta, or increased TT-TG.

Experience and volume are determinantive factors for operative management of supracondylar humeral fractures in children.

BACKGROUND: We compared radiographic and operative results of pediatric patients undergoing surgical treatment of displaced supracondylar humeral fracture (SCHF) according to the surgeon's experience. METHODS: During an 11-year period (2006-2016), we reviewed the medical records of 236 patients operated on for Gartland III SCHF in our institution. Operative (operative time, time to implants removal) and radiographic parameters (Baumann and lateral capitellohumeral angles) were assessed. A malalignment was defined if there was a difference in the Baumann angle or lateral capitellohumeral angles >15° or if malrotation existed compared with normative values. We compared surgeon experience and volume (number of patients operated on by year). RESULTS: In patients operated on by less experienced surgeons (<1 year, n = 69), operative time (61 vs. 41 minutes) and time to implant removal (48 vs. 40 days) were significantly longer (P < .001). Radiographic parameters did not differ between less and more experienced surgeons. Operative parameters improved through the 20 first cases of the younger surgeons. In surgeons managing fewer than 5 patients per year, malalignment and conversion to open reduction were more frequent (all P < .05). CONCLUSION: Experience and volume are 2 crucial parameters influencing the quality of management of pediatric patients undergoing surgical treatment for displaced SCHF. They should be taken into account in daily practice, especially when making the decision to operate on these patients out of day time.

Bone substitutes in adolescent idiopathic scoliosis surgery using sublaminar bands: is it useful? A case-control study.

INTRODUCTION: In order to avoid pseudarthrosis in adolescent idiopathic (AIS) patients, it is recommended to bring additional bone graft or substitute. Modern rigid instrumentations have been shown to provide less pseudarthroses even without bone substitutes. The aim of our study was to determine the impact of using bones substitutes on fusion rates in adolescent idiopathic scoliosis patients undergoing PSF with sublaminar bands. METHOD: AIS patients scheduled to undergo PSF with sublaminar bands were prospectively enrolled into this study and not given any bone substitutes (no-substitute group). Data were collected and analyzed in patients with at least two years of follow-up. Pseudarthrosis was diagnosed if at least one of the following was present: persistent back pain, hardware failure, loss of correction greater than 10°. The results were compared to a control group who received bone substitutes for the same surgical procedure. RESULTS: Eighty-eight patients were included. For the whole cohort, the mean age was 14.8 years old and the mean follow-up was 30.9 months. For the 'no-substitute' group (n = 44), the mean Cobb angle was 56° pre-operatively, 20.1° post-operatively, and 22° at final follow-up. The fusion rate was not statistically different between the two groups (97.7% vs 95.5%, p = 0.56). At last follow-up, one pseudarthrosis occurred in the 'no substitute' group and two in the control group. DISCUSSION: This is the first study to determine the impact of bone substitutes in AIS fusion using sublaminar bands. In our study, the use of local autologous bone graft alone resulted in a fusion rate of 97.7% despite the use of more flexible instrumentation. The high rate of fusion in AIS patients is more probably due to the healing potential of these young patients rather than to the type of instrumentation. CONCLUSION: The use of additional bone graft or bone substitutes may not be mandatory when managing AIS. LEVEL OF EVIDENCE: 4.

Magnetically controlled growing rod in early onset scoliosis: a 30-case multicenter study.

PURPOSE: Preliminary results of magnetically controlled growing rods (MCGR) are encouraging. However, only short case series of MCGR for the treatment of early onset scoliosis (EOS) have been reported. Our aim was to evaluate its effectiveness and complications. METHODS: We report a 30-case retrospective, consecutive, multicenter series of MCGR. Effectiveness was judged upon: deformity correction and difficulties to achieve desired distraction. Secondary endpoints included complications and revision surgeries. RESULTS: Median age at surgery was 9.1 years (5-13). Mean follow-up was 18.4 months (12-33.9). Mean Cobb angle was 66° preoperatively and 44° at latest follow-up. MCGR has avoided an average of 2.03 scheduled surgical procedures per patient compared to traditional growing rod (GR). The intended total length gain was 40.1 mm per patient (5-140) and the total measured length gain was 21.9 mm (45.5% discrepancy). There were 24 complications: 7 proximal pull-outs of the hooks, 3 rod breakages, 6 failures of the lengthening of which 4 complete blockages and 2 complete blockages followed by backtracking, 1 proximal junctional kyphosis, 1 wound dehiscence, 1 superficial infection, 1 deep infection requiring implant removal, 1 pulmonary embolism, 1 pulmonary insufficiency, 1 secondary lumbar scoliosis, and 1 painful outpatient distraction. Eight patients had a gradual loss of effectiveness of distractions. There were 13 revision surgeries in 9 patients. CONCLUSIONS: MCGR provides satisfactory deformity correction and avoids repeated surgical procedures for lengthening. However, it has substantial complication rate. Although less frequent than in GR, the law of diminishing returns also applies to MCGR.

Pseudoaneurysm of anterior tibial artery following a diaphyseal fracture of the tibia mimicking a malignant bone tumor.

Pseudoaneurysms of the lower limb are rare and frequently iatrogenics complications. Closed traumas are likely to generate lesions of the arterial wall, which generally become symptomatic at a later stage. The diagnosis of such vascular lesion is difficult because the symptomatology and the onset can be delayed. We herein report the case of a 15-year-old patient in whom the diagnosis of pseudoaneurysm of the anterior tibial artery was made 5 months after a non-displaced closed fracture of the tibial shaft. The radiographs were evocative of a malignant bone tumor. The study of vessels by a contrast-enhanced CT-scan enabled us to diagnose the pseudoaneurysm. Before the occurrence of late onset swelling, a history of trauma must be sought, even old.

[Case study of two children with intervertebral disc calcifications]. / Calcifications discales intervertébrales chez l'enfant: à propos de deux cas.

Disc calcifications are usually revealed in children by pain crises that affect the spine. The most common location for disc calcifications is the cervical spine. However, other locations are less symptomatic and they may well go unnoticed. We here report two cases of children hospitalized with symptomatic cervical disc calcifications. The first case involves a girl aged four and a half suffering from torticollis revealing the migration of a previously asymptomatic disc calcification ; the second case, instead, involves a 5-year old boy presenting for acute neck pain and in whom calcification disc was detected. Treatment was essentially conservative. Intervertebral disc calcifications in children are a rare condition whose etiopathogenesis remains unknown. In the case of children with unexplained back pain the diagnosis should not be made without careful neurological examination and imaging tests.

Metastatic renal cell carcinoma presenting as foot metastasis: case report and review of the literature.

Malignant tumors frequently metastasize to bone centrally in the skeleton. Metastatic disease distal to the knee is unusual. Metastasis to the foot (acrometastasis) is rare (0.01%) and is usually a late manifestation of disseminated disease. The purpose of this article is to present a rare case of metastatic renal cell carcinoma with foot metastasis as the primary manifestation along with another rare localization of metastatic disease distal to the knee, in the contralateral tibial diaphysis. To highlight the delay in diagnosis of such a rare condition to consider it in the diagnosis of a painful foot, we also present a review of the literature.

Autologous bone marrow graft and treatment of delayed and non-unions of long bones: technical aspects.

This article reports the technique of percutaneous autologous bone marrow injection as a minimally invasive method alternative to open grafting techniques in the treatment of delayed unions and non-unions. Despite continuous advances in the treatment of long bone fractures, disturbances of healing processes remain a difficult challenge for orthopaedic surgeons. Percutaneous administration of substances with osteoinductive and osteogenic properties offers the advantage of decreased morbidity associated with the classic open grafting techniques. This makes it worth exploring before embarking on more extensive open surgery. The authors present the main technical stages of the percutaneous bone marrow grafting (bone marrow aspiration, concentration, intra-osseous re-injection and post-operative protocol) with a short literature review about this topic.

Tolerability and efficacy of thalidomide for the treatment of patients with light chain-associated (AL) amyloidosis.

Thalidomide is an effective therapy for multiple myeloma, although its mechanisms of action remain unclear. Light chain-associated (AL) amyloidosis is a plasma cell disorder related to multiple myeloma, but in AL amyloidosis, fibrillar tissue deposits of clonal immunoglobulin light chains produce organ dysfunction. To test the toxicity and efficacy of thalidomide in AL amyloidosis we initiated a phase I/II trial for patients with AL amyloidosis, most of whom had failed prior therapy with high-dose melphalan and autologous stem cell transplantation. This trial was designed as an individualized 6-month dose-escalation study with reevaluation of bone marrow plasmacytosis and serum and urine monoclonal proteins after 3 and 6 months. Sixteen patients were enrolled in the study with a median age of 62 years (range, 37-70 years). Fourteen patients had renal involvement, 4 had cardiac involvement, 4 had liver involvement, and 2 had predominant soft tissue or lymph node involvement. The median maximum tolerated dose was 300 mg, with fatigue and other central nervous system side effects being the major dose-limiting toxicities. Side effects not frequently reported for other patient populations included exacerbation of peripheral and pulmonary edema and worsening azotemia. In all, 50% of patients experienced grade 3/4 toxicity, and 25% had to discontinue the study drug. No complete hematologic responses were seen, but 25% of patients had a significant reduction in Bence-Jones proteinuria. Thus, while thalidomide has activity in AL amyloidosis, it also has significant toxicity in this patient population.