Effects of Pulsed Electromagnetic Fields on Return to Sports After Arthroscopic Debridement and Microfracture of Osteochondral Talar Defects: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.

BACKGROUND: Osteochondral defects (OCDs) of the talus usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracture. Various possibilities have been suggested to improve the recovery process after debridement and microfracture. A potential solution to obtain this goal is the application of pulsed electromagnetic fields (PEMFs), which stimulate the repair process of bone and cartilage. HYPOTHESIS: The use of PEMFs after arthroscopic debridement and microfracture of an OCD of the talus leads to earlier resumption of sports and an increased number of patients that resume sports. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 68 patients were randomized to receive either PEMFs (n = 36) or placebo (n = 32) after arthroscopic treatment of an OCD of the talus. The primary outcomes (ie, the number of patients who resumed sports and time to resumption of sports) were analyzed with Kaplan-Meier curves as well as Mann-Whitney U, chi-square, and log-rank tests. Secondary functional outcomes were assessed with questionnaires (American Orthopaedic Foot and Ankle Society ankle-hindfoot score, Foot and Ankle Outcome Score, EuroQol, and numeric rating scales for pain and satisfaction) at multiple time points up to 1-year follow-up. To assess bone repair, computed tomography scans were obtained at 2 weeks and 1 year postoperatively. RESULTS: Almost all outcome measures improved significantly in both groups. The percentage of sport resumption (PEMF, 79%; placebo, 80%; P = .95) and median time to sport resumption (PEMF, 17 weeks; placebo, 16 weeks; P = .69) did not differ significantly between the treatment groups. Likewise, there were no significant between-group differences with regard to the secondary functional outcomes and the computed tomography results. CONCLUSION: PEMF does not lead to a higher percentage of patients who resume sports or to earlier resumption of sports after arthroscopic debridement and microfracture of talar OCDs. Furthermore, no differences were found in bone repair between groups. REGISTRATION: Netherlands Trial Register NTR1636.

Oral high dose ascorbic acid treatment for one year in young CMT1A patients: a randomised, double-blind, placebo-controlled phase II trial.

BACKGROUND: High dose oral ascorbic acid substantially improved myelination and locomotor function in a Charcot-Marie-Tooth type 1A mouse model. A phase II study was warranted to investigate whether high dose ascorbic acid also has such a substantial effect on myelination in Charcot-Marie-Tooth type 1A patients and whether this treatment is safe. METHODS: Patients below age 25 years were randomly assigned to receive placebo or ascorbic acid (one gram twice daily) in a double-blind fashion during one year. The primary outcome measure was the change over time in motor nerve conduction velocity of the median nerve. Secondary outcome measures included changes in minimal F response latencies, compound muscle action potential amplitude, muscle strength, sensory function, Charcot-Marie-Tooth neuropathy score, and disability. RESULTS: There were no significant differences between the six placebo-treated (median age 16 years, range 13 to 24) and the five ascorbic acid-treated (19, 14 to 24) patients in change in motor nerve conduction velocity of the median nerve (mean difference ascorbic acid as opposed to placebo treatment of 1.3 m/s, confidence interval -0.3 to 3.0 m/s, P = 0.11) or in change of any of the secondary outcome measures over time. One patient in the ascorbic acid group developed a skin rash, which led to discontinuation of the study medication. CONCLUSION: Oral high dose ascorbic acid for one year did not improve myelination of the median nerve in young Charcot-Marie-Tooth type 1A patients. Treatment was relatively safe. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56968278, ClinicalTrials.gov NCT00271635.

Subcutaneous immunoglobulin therapy for multifocal motor neuropathy.

The objective of this study was to investigate whether subcutaneous immunoglobulin (SCIg) treatment is feasible and safe in maintaining muscle strength of patients with multifocal motor neuropathy (MMN). Patients fulfilling the EFNS/PNS criteria for definite MMN treated with intravenous immunoglobulin (IVIg) were switched to weekly SCIg in a single-center, open-label pilot intervention study. The first group of patients started with a SCIg dose equivalent to 50% of the IVIg maintenance dose. In case of deterioration, patients received a loading dose of IVIg and doubling of SCIg dose. The second group started with a dose equivalent to the IVIg maintenance dose. Primary outcome was the Medical Research Council (MRC) sum score from 10 muscle groups. Secondary outcomes were grip and pinch strength, dexterity, disability, quality of life, adverse events, and serum immunoglobulin concentrations. Ten patients were included, five in both groups. In the first group, one patient withdrew informed consent due to local adverse events, four deteriorated. In the second group, four out of five patients maintained muscle strength with SCIg during the 6 months follow-up. Local adverse events were frequent, especially during first weeks of treatment, but generally well tolerated. Seven mild systemic adverse events were reported, all but one in the first week of treatment. In some, but not all MMN patients in this study, SCIg therapy was feasible and safe and maintained strength as well as IVIg. SCIg may be a viable alternative maintenance therapy in some patients with MMN currently receiving IVIg.

Pulsed electromagnetic fields after arthroscopic treatment for osteochondral defects of the talus: double-blind randomized controlled multicenter trial.

BACKGROUND: Osteochondral talar defects usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracturing. Although this is mostly successful, early sport resumption is difficult to achieve, and it can take up to one year to obtain clinical improvement. Pulsed electromagnetic fields (PEMFs) may be effective for talar defects after arthroscopic treatment by promoting tissue healing, suppressing inflammation, and relieving pain. We hypothesize that PEMF-treatment compared to sham-treatment after arthroscopy will lead to earlier resumption of sports, and aim at 25% increase in patients that resume sports. METHODS/DESIGN: A prospective, double-blind, randomized, placebo-controlled trial (RCT) will be conducted in five centers throughout the Netherlands and Belgium. 68 patients will be randomized to either active PEMF-treatment or sham-treatment for 60 days, four hours daily. They will be followed-up for one year. The combined primary outcome measures are (a) the percentage of patients that resume and maintain sports, and (b) the time to resumption of sports, defined by the Ankle Activity Score. Secondary outcome measures include resumption of work, subjective and objective scoring systems (American Orthopaedic Foot and Ankle Society--Ankle-Hindfoot Scale, Foot Ankle Outcome Score, Numeric Rating Scales of pain and satisfaction, EuroQol-5D), and computed tomography. Time to resumption of sports will be analyzed using Kaplan-Meier curves and log-rank tests. DISCUSSION: This trial will provide level-1 evidence on the effectiveness of PEMFs in the management of osteochondral ankle lesions after arthroscopy. TRIAL REGISTRATION: Netherlands Trial Register (NTR1636).

HIV-associated anemia in children: a systematic review from a global perspective.

OBJECTIVES: To assess the importance of anemia in HIV-infected children in western and tropical settings. DESIGN: A systematic review with a descriptive component. METHODS: : Four databases were searched and reference lists of pertinent articles were checked. Studies that reported data on anemia or hemoglobin levels in HIV-infected children were selected and grouped according to the location and the definition of anemia. RESULTS: Thirty-six studies met the inclusion criteria. Mild (hemoglobin <11 g/dl) and moderate (hemoglobin <9 g/dl) anemia were more prevalent with HIV infection (odds ratio 4.5; 95% confidence interval 2.5-8.3 and odds ratio 4.5; 95% confidence interval 2.0-10.3, respectively). Mean hemoglobin levels were lower (standardized mean difference; 0.79; 95% confidence interval 0.47-1.10). These differences were observed in both western and tropical settings. Anemia incidence ranged from 0.41 to 0.44 per person-year. There was limited data on more severe anemia (hemoglobin <7 or <5 g/dl). As anemia was frequently identified as an independent risk factor for disease progression and death, we next reviewed the limited data to formulate better strategies. Failure of erythropoiesis was the most important mechanism for anemia in HIV-infected children. Therapeutic options include highly active antiretroviral therapy and prevention or treatment of secondary infections. Erythropoietin can improve anemia in children, but it has not been evaluated in developing countries. Micronutrient supplementation may be helpful in individual children. The potential benefits or risks of iron supplementation in HIV-infected children require evaluation. CONCLUSION: Anemia is a very common complication of pediatric HIV infection, associated with a poor prognosis. With the increasing global availability of highly active antiretroviral therapy, more data on the safety and efficacy of possible interventions in children are urgently needed.