A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain.
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Electric Stimulation Therapy↗
Biomedical subjects
Jon E Block
Publications and source records attributed to Jon E Block.
Intradiscal electrothermal therapy (IDET).
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Electric Stimulation Therapy↗
Grafting long bone fractures with demineralized bone matrix putty enriched with bone marrow: pilot findings.
In this pilot study, the preliminary effectiveness of a composite graft consisting of demineralized bone matrix (DBM) putty (Grafton DBM) and aspirated bone marrow was evaluated for treating long bone fractures. Patients were ssigned randomly to treatment with the DBM putty composite (n = 10) or iliac crest autograft (n = 8), and had a minimum of 12 months of radiographic follow-up. Ninety percent of DBM patients (9/10) achieved full bone formation compared to 75% of autograft patients (6/8) (P = .41). Additionally, all 10 DBM patients were healed compared with 63% of autograft patients (5/8) (P = .07). These findings suggest that DBM putty enriched with bone marrow may be comparable to autograft for treating long bone fractures.
Adult↗
The impact of irradiation on the microbiological safety, biomechanical properties, and clinical performance of musculoskeletal allografts.
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Biomechanical Phenomena↗
Treatment of intractable discogenic low back pain. A systematic review of spinal fusion and intradiscal electrothermal therapy (IDET).
BACKGROUND: A growing number of patients suffer from severe low back pain of discogenic origin that is not responsive to conservative medical management. These patients must consider the option of surgical spinal fusion or minimally-invasive intradiscal electrothermal therapy (IDET). OBJECTIVE: To conduct a systematic review of clinical outcomes in patients undergoing spinal fusion or the intradiscal electrothermal therapy (IDET) procedure for intractable discogenic low back pain. DESIGN: Systematic literature review. METHODS: English-language journal articles published from January 1995 to December 2005 were identified through computerized searches of the PubMed database and bibliographies of identified articles and review papers. Articles were selected if disc degeneration or disruption was the primary indication for spinal fusion or the IDET procedure and if follow-up outcome data included evaluations of back pain severity, condition-specific functional impairment and/or health-related quality of life. The literature reviewed encompassed 33 spinal fusion articles: 10 randomized controlled trials, 1 nonrandomized controlled trial, 9 before-after trials, and 13 case series. There were 18 IDET articles: 2 randomized controlled trial, 2 nonrandomized controlled trials, 11 before- after trials, and 3 case series. Data were extracted and summarized on patient characteristics, surgical methods, and clinical outcomes. RESULTS: Overall, there were similar median percentage improvements realized after spinal fusion and the IDET procedure, respectively, for 2 of the 3 outcomes evaluated: pain severity (50%, 51%), back function (42%, 14%) and quality of life (46%, 43%). There was an identifiable randomized controlled trials trend of both treatments reporting a smaller magnitude of improvement in all 3 primary outcomes (pain severity, back function, quality of life) compared to other types of trials. Perioperative complications were commonly associated with spinal fusion (median: 14%, range: 2% to 54%, n = 31 study groups) whereas adverse events were rarely experienced with the IDET procedure (median: 0%, range: 0% to 16%, n = 14 studies). Randomized controlled trials of spinal fusion, in particular, had important methodological limitations. CONCLUSION: The majority of patients reported improvement in symptoms following both spinal fusion and the IDET procedure. The IDET procedure appears to offer sufficiently similar symptom amelioration to spinal fusion without the attendant complications.
Electric Stimulation Therapy↗
Hybrid therapy with right atrial catheter ablation and previously ineffective antiarrhythmic drugs for the management of atrial fibrillation.
BACKGROUND: Many patients with paroxysmal atrial fibrillation (AF) become refractory to antiarrhythmic drugs (AADs). Early studies suggested that linear catheter ablation in the right atrium may provide sufficient substrate modification to reestablish therapeutic efficacy of previously ineffective AADs. METHODS: This prospective before-after multicenter trial evaluated the safety and effectiveness of hybrid therapy that included right atrial catheter ablation coupled with a regimen of previously ineffective AADs on AF episode frequency and symptoms in drug refractory patients with paroxysmal AF. A standard linear lesion set (lateral, septal, isthmus) was used in all subjects. AF episode frequency, clinical arrhythmia symptoms, condition-specific (AFSS) and global health-related quality of life (SF-36) were assessed prior to ablation and at 6 months. RESULTS: Ninety-three subjects, refractory to an average 2.9 AADs at baseline, qualified for inclusion and underwent right atrial catheter ablation. Eighty-four subjects (90%) provided 6 month AF episode frequency data which demonstrated a significant decrease compared to baseline (3.4 vs. 9.5, p < 0.0001). Forty-nine subjects (58%) were considered a clinical success by virtue of achieving a pre-specified target level episode frequency reduction of 50% or greater. Substantial and statistically significant improvements were realized almost uniformly for all measured arrhythmia symptoms as well as for both quality of life measures. The incidence of major complications was 5.4%. CONCLUSIONS: The addition of right atrial catheter ablation to a regimen of previously ineffective AADs is associated with a significant reduction in the frequency, duration and severity of AF episodes and symptoms.
Amiodarone↗
Severe blood loss during spinal reconstructive procedures: the potential usefulness of topical hemostatic agents.
Complex spinal reconstructive procedures are invariably associated with excessive intraoperative blood loss that significantly increases the risk of severe perioperative complications. In some cases, excessive hemorrhage is equivalent to estimated total blood volume. Unfortunately, widely exposed bony surfaces are not amenable to standard hemostatic maneuvers utilized during soft tissue surgery. This article evaluates the clinical effectiveness of several approaches to blood management in this setting, and hypothesizes that underappreciated topical hemostatic agents may provide benefit by reducing the need for autologous predonation, banked donor blood or antifibrinolytic agents. Topical agents combining collagen, thrombin and fibrin have demonstrated initial promise by inducing platelet aggregation and initiating the clotting cascade when applied directly to bleeding bony sites. Clinical studies are clearly warranted.
Administration, Topical↗
The role and effectiveness of bone marrow in osseous regeneration.
Autologous bone marrow serves as the richest and most readily available repository of progenitor cells capable of differentiating into mature bone forming cells. Numerous studies have demonstrated that bone marrow alone or cell suspensions of marrow usually diluted in culture medium affect de novo bone formation when implanted in soft tissue sites. Consequently, when bone marrow is used to enrich orthopaedic grafting matrices such as xenograft, demineralized bone matrix, or ceramic materials it almost invariably produces faster and more consistent defect healing compared to bone marrow or the carrier matrix alone and, in some cases, equivalent healing to autograft. This article evaluates the clinical effectiveness of these grafting materials for various orthopaedic applications such as healing long bone defects and enhancing spinal fusion procedures, and hypothesizes that enrichment with bone marrow is integral to timely and satisfactory graft incorporation. Methods such as centrifugation, culture expansion and selective cell retention that concentrate and deliver marrow-derived osteoprogenitor cells to the graft site as a means of mimicking more closely the consistent bone forming potential of autologous bone graft are also discussed.
Animals↗
Sexual functioning and satisfaction in nonresponders to testosterone gel: Potential effectiveness of retreatment in hypogonadal males.
There is a slow but continuous decline in testosterone (T) levels with age, with a substantial percentage of males exhibiting T levels in the hypogonadal range. This age-dependent decline in circulating androgens is associated, in large part, with reduced sexual functioning and libido. The effectiveness of TestimR 1% (Auxilium Pharmaceuticals, Inc., Norristown, Pennsylvania) topical T gel was evaluated in older hypogonadal males who failed to experience satisfactory symptom relief after treatment with AndroGelR 1% (Solvay Pharmaceuticals, Inc., Marietta, Georgia). In this open-label study, consecutive subjects were assigned randomly to experimental treatment with Testim 1% (5 g) or to maintenance therapy (control group) with AndroGel 1% (5 g). Seventy-six experimental subjects and 75 control subjects were followed for 4 weeks to evaluate improvements in sexual functioning and satisfaction. Changes from baseline in the 5 domains of the Brief Male Sexual Function Inventory were compared between groups. The mean percentage improvement favored the experimental treatment in sexual drive (23% vs 16%, P < 0.3), erectile function (32% vs 8%, P < 0.03), ejaculatory function (11% vs 9%, P < 0.4), problem assessment (47% vs 12%, P < 0.01), and sexual satisfaction (62% vs 23%, P < 0.02). A greater percentage of subjects also reported satisfaction with the experimental treatment (55% vs 33%, P < 0.02), and these subjects were less likely to require upward dose titration at the final follow-up visit (53% vs 72%, P < 0.03). Consideration of Testim 1% gel in patients who have an inadequate response to prior T therapy is encouraged, although it is difficult to estimate the contribution of nonspecific study effects (eg, placebo) in this trial.
Androgens↗
Improvement in sexual functioning and satisfaction in nonresponders to testosterone gel: clinical effectiveness in hypogonadal, HIV-positive males.
Impairment in gonadal function with reduced testosterone (T) levels is commonly associated with HIV infection and patients often complain of diminished libido and sexual dysfunction. The effectiveness of Testim 1% (Auxilium Pharmaceuticals, Inc., Norristown, Pennsylvania) topical T gel was evaluated in HIV-positive males who failed to experience satisfactory symptom relief following prior treatment with AndroGel 1% (Solvay Pharmaceuticals, Inc., Marietta, Georgia). In this open-label study, consecutive subjects were randomly assigned to experimental treatment with Testim 1% (5 g) or to maintenance therapy (control group) with AndroGel 1% (5 g). Twenty-four experimental subjects and 24 control subjects were followed for 4 weeks to evaluate improvements in sexual functioning and satisfaction. Changes from baseline in the 5 domains of the Brief Male Sexual Function Inventory (BMSFI) were compared between groups. The average percentage improvement favored the experimental treatment in all 5 comparisons of the BMSFI, including sexual drive (53% vs 18%, P < 0.001), erectile function (49% vs 7%, P < 0.004), ejaculatory function (15% vs 8%, P < 0.14), problem assessment (59% vs 12%, P < 0.003), and sexual satisfaction (58% vs 9%, P < 0.006). A greater percentage of subjects also reported satisfaction with the experimental treatment (85% vs 48%, P < 0.03), and these subjects were less likely to require upward dose titration at the final follow-up visit (30% vs 74%, P = 0.01). It is hypothesized that the results of the current study may be explained, in part, by an improved pharmacokinetic profile of the experimental intervention. Consideration of Testim 1% gel in HIV patients who have an inadequate response to prior T therapy is encouraged, although it is difficult to estimate the contribution of nonspecific study effects (eg, placebo) in this trial.
Adult↗
Glycemic characteristics in continuously monitored patients with type 1 and type 2 diabetes: normative values.
OBJECTIVE: The purpose of this study was to generate normative values for periods of euglycemia as well as for daily patterns of glycemic excursions in patients with type 1 and type 2 diabetes monitored continuously for a maximum period of 21 days and blinded to glucose levels. RESEARCH DESIGN AND METHODS: This was a multicenter, prospective observational study in which 101 consecutive patients with type 1 (n = 60) or type 2 (n = 41) diabetes underwent blinded continuous glucose monitoring. Serial glucose measurements were divided into periods of euglycemia (70-180 mg/dl), hyperglycemia (>180 mg/dl), and hypoglycemia (<70 mg/dl). The proportions of time patients were hypoglycemic, euglycemic, and hyperglycemic and the total areas under the curves (AUCs) were determined. RESULTS: During the observation period the 101 subjects contributed an average 287 +/- 132 h of continuous glucose values. Subjects remained in the euglycemic range for approximately 63% of the total day, were hypoglycemic 8%, and were hyperglycemic 29%. Hypoglycemia was more prevalent nocturnally (11 vs. 7%) and hyperglycemia diurnally (31 vs. 25%). Compared with subjects with type 2 diabetes, type 1 diabetic subjects had more frequent hypoglycemic episodes per day (2.1 vs. 1.0; P < 0.001) that were of longer duration (1.1 vs. 0.7 h; P < 0.0001), reflecting a greater number of hours per day in the hypoglycemic range (2.3 vs. 1.0 h; P < 0.0001). The mean hypoglycemic AUC values were >150% higher for type 1 compared with type 2 diabetic subjects (41 vs. 16, respectively; P < 0.0001). CONCLUSIONS: These normative data will assist in study and sample size planning for future investigations of continuous glucose monitoring and allow for qualitative comparisons with trials of therapeutic interventions aimed at reducing the occurrence of glycemic excursions.
Adult↗
Reducing the risk of deep wound infection in primary joint arthroplasty with antibiotic bone cement.
Despite significant advances in intraoperative antimicrobial procedures, deep wound infection remains the most serious complication associated with primary, cemented total joint arthroplasty. A systematic review was conducted to evaluate studies of antibiotic bone cement prophylaxis for reducing the risk of deep wound infection. The literature included 22 articles providing estimates of the prophylactic effectiveness of antibiotic cement. In reducing deep wound infection, antibiotic cement was consistently superior to plain cement, similar to systematic antiobiotics, and independent and additive in effect when combined with other prophylactic measures. Randomized controlled trials in particular had important methodological limitations. However, the collective results nearly unanimously favored prophylactic use of antibiotic cement in primary arthoplasty procedures.
Anti-Bacterial Agents↗
Fixed-flexion radiography of the knee provides reproducible joint space width measurements in osteoarthritis.
The validity of a non-fluoroscopic fixed-flexion radiographic acquisition and analysis protocol for measurement of joint space width (JSW) in knee osteoarthritis is determined. A cross-sectional study of 165 patients with documented knee osteoarthritis participating in a multicenter, prospective study of chondroprotective agents was performed. All patients had posteroanterior, weight-bearing, fixed-flexion radiography with 10 degrees caudal beam angulation. A specially designed frame (SynaFlexer) was used to standardize the positioning. Minimum medial and lateral JSW were measured manually and twice by an automated analysis system to determine inter-technique and intra-reader concordance and reliability. A random subsample of 30 patients had repeat knee radiographs 2 weeks apart to estimate short-term reproducibility using automated analysis. Concordance between manual and automated medial JSW measurements was high (ICC=0.90); lateral compartment measurements showed somewhat less concordance (ICC=0.72). There was excellent concordance between repeated automated JSW measurements performed 6 months apart for the medial (ICC=0.94) and lateral (ICC=0.86) compartments. Short-term reproducibility for the subsample of 30 cases with repeat acquisitions demonstrated an average SD of 0.14 mm for medial JSW (CV=4.3%) and 0.23 mm for lateral JSW (CV=4.0%). Fixed-flexion radiography of the knee using a positioning device provides consistent, reliable and reproducible measurement of minimum JSW in knee osteoarthritis without the need for concurrent fluoroscopic guidance.
Aged↗
Two-year fusion rate equivalency between Grafton DBM gel and autograft in posterolateral spine fusion: a prospective controlled trial employing a side-by-side comparison in the same patient.
STUDY DESIGN: Multicenter, prospective equivalency trial with each patient serving as his/her own control. OBJECTIVES: To compare the effectiveness of a Grafton DBM gel composite with iliac crest autograft in posterolateral spine fusion. SUMMARY OF BACKGROUND DATA: While autograft remains the preferred graft material to facilitate spine fusion, the supply is limited and harvesting produces undesirable clinical consequences. METHODS: A total of 120 patients underwent posterolateral spine fusion with pedicle screw fixation and bone grafting. Iliac crest autograft was implanted on one side of the spine and a Grafton DBM/autograft composite was implanted on the contralateral side in the same patient. An independent, blinded reviewer evaluated anteroposterior and lateral flexion-extension radiographs. The fusion mass lateral to the instrumentation on each side was judged fused or not, and the mineralization of the graft was rated absent, mild, moderate, or extensive. The degree of correspondence in outcomes between sides was estimated by computing the percentage agreement and kappa statistic. RESULTS: Nearly 70% of patients (81 of 120) provided complete 24-month radiographic studies. The bone graft mass was fused in 42 cases (52%) on the Grafton DBMside and in 44 cases (54%) on the autograft side. The overall percentage agreement for fusion status between sides was approximately 75% (61 of 81), indicating moderately strong statistical correspondence (kappa = 0.51, P < 0.0001). Bone mineralization ratings also were similar between treated sides. Perfect agreement was realized in almost 60% of patients (48 of 81) with moderate statistical correspondence (weighted kappa = 0.54, P < 0.0001). CONCLUSIONS: Grafton DBM can extend a smaller quantity of autograft than is normally required to achieve a solid spinal arthrodesis. Consequently, a reduced amount of harvested autograft may be required, potentially diminishing the risk and severity of donor site complications.
Bone Matrix↗
Improved intraoperative management of anastomotic bleeding during aortic reconstruction: results of a randomized controlled trial.
In a randomized controlled trial, the effectiveness of a polymeric surgical sealant (CoSeal) was compared to Gelfoam/thrombin for managing anastomotic bleeding after implantation of Dacron grafts during aortic reconstruction for nonruptured aneurysms. Each treatment was directly applied to the suture line after confirmation of anastomotic bleeding. The proportion of suture line sites that achieved immediate sealing and the proportion sealed within 5 minutes were determined among 37 experimental (59 sites) and 17 control subjects (27 sites). A significantly greater proportion of bleeding suture line sites treated with the polymeric sealant achieved immediate sealing following reestablishment of blood flow compared with control-treated sites [48 of 59 (81%) vs 10 of 27 (37%); P = 0.002]. The difference between treatment groups was maintained after 5 minutes with approximately 85 per cent (50 of 59) of CoSeal sites compared to just over one-half (14 of 27) of control sites demonstrating ultimate sealing (P = 0.01). There were no adverse events related to the use of the polymeric sealant in this study. These results support the use of this novel sealant for the intraoperative management of anastomotic bleeding during aortic reconstruction procedures.
Adult↗
Right atrial ablation in the management of atrial fibrillation: point of view.
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Atrial Fibrillation↗
Reducing the incidence and severity of pericardial adhesions with a sprayable polymeric matrix.
PURPOSE: This study was undertaken to evaluate the antiadhesive properties of a polymeric agent in infants undergoing staged surgical correction of congenital heart abnormalities. DESCRIPTION: Sixteen infants having staged surgical repair were treated with a polymeric matrix at the completion of the initial surgery. There were 5 untreated controls. The tenacity and extent of adhesions at five separate regions of the heart were evaluated at the follow-up surgery. EVALUATION: For all sites combined, there was a threefold difference in median tenacity scores in favor of the experimental treatment (1.0 vs 3.0, p < 0.01). Significant differences were achieved separately at the right ventricle and the anterior surface of the great vessels (p = 0.02 for both comparisons). Analysis of adhesion scores reflecting the extent of adhesions similarly favored the experimental treatment for all sites (80 vs 270, p < 0.01), with significant differences persisting at the right atrium (p < 0.01) and the anterior surface of the great vessels (p = 0.04). There were no treatment-related adverse events. CONCLUSIONS: Use of this polymeric agent at the completion of open cardiac surgery may prevent the occurrence or reduce the severity of pericardial adhesions.
Female↗
Osteoinduction by a collagen mineral composite combined with isologous bone marrow in a subcutaneous rat model.
In a subcutaneous implant rat model, Collagraft alone (n=8), Collagraft plus isologous bone marrow (n=8), and marrow alone (n=8) were evaluated. Twelve rats were euthanized at 11 days and 12 at 21 days. Explants were evaluated histologically for evidence of bone formation, and osteogenic activity was determined by an assay for alkaline phosphatase. Histological bone formation was absent in all groups at 11 days. At 21 days, in the Collagraft alone and bone marrow alone groups, no bone induction was noted. In contrast, 21-day specimens from the Collagraft plus bone marrow group showed newly formed bone. Alkaline phosphatase activity was negligible (<0.05 units/mg) in all 11-day specimens. Activity in Collagraft plus bone marrow specimens at 21 days (0.38 units/mg) was significantly higher than any other group (P<.001 for all comparisons). This study demonstrates that Collagraft plus bone marrow is an osteoinductive matrix.
Animals↗