Adam S. Landsman

Extracellular Matrix Biomaterials for Soft Tissue Repair

The biological and physical augmentation provided by extracellular matrix (ECM) derived implants continues to challenge and refine the conventional wisdom of biomaterials. It is now appreciated that different tissue-processing methodologies can produce ECM devices with characteristic post-implantation responses ranging from the classic foreign body encapsulation of a permanent implant, to one where the implant is degraded and resorbed, to one where the processed ECM implant is populated by local fibroblasts and supporting vasculature to generate a new, metabolically active tissue (gTissue). This article reviews the multiple ECM devices available clinically and highlights the impact of tissue source and processing on physicomechanical properties and host-implant interactions, with regard to surgical applications and clinical considerations.

Treatment of Mild, Moderate, and Severe Onychomycosis Using 870- and 930-nm Light Exposure

BACKGROUND The Noveon is a unique dual-wavelength near-infrared diode laser used to treat onychomycosis. The device operates at physiologic temperatures that are thermally safe for human tissue. It uses only 870- and 930-nm near-infrared light, wavelengths that have unique photolethal effects on fungal pathogens. These wavelengths lack the teratogenic danger presented by ultraviolet light and the photoablation toxic plume associated with pulsed Nd:YAG lasers. METHODS In this randomized controlled study, treatments followed a predefined protocol and laser parameters and occurred on days 1, 14, 42, and 120. Toes were cultured and evaluated, and measurements were taken from standardized photographs obtained periodically during the 180 day follow-up period. RESULTS We treated mycologically confirmed onychomycosis in 26 eligible toes (ten mild, seven moderate, and nine severe). All of the patients were followed-up for 180 days. An independent expert panel, blinded regarding treatment versus control, found that at 180 days, 85% of the eligible treated toenails were improved by clear nail linear extent (P = .0015); 65% showed at least 3 mm and 26% showed at least 4 mm of clear nail growth. Of the 16 toes with moderate to severe involvement, ten (63%) improved, as shown by clear nail growth of at least 3 mm (P = .0112). Simultaneous negative culture and periodic acid-Schiff was noted in 30% at 180 days. CONCLUSIONS These results indicate a role for this laser in the treatment of onychomycosis, regardless of degree of severity. Ease of delivery and the lack of a need to monitor blood chemistry are attractive attributes.

Meta-analysis of first metatarsophalangeal joint implant arthroplasty.

UNLABELLED Management of late-stage degenerative joint disease of the first metatarsophalangeal joint (MPJ) is a complex topic that is frequently the source of debate among foot and ankle surgeons. Several surgical interventions have been described to treat this condition. One of the most contested of these treatments is implant arthroplasty of the first MPJ. The primary aim of this meta-analysis was to evaluate the clinical benefit of first MPJ implant arthroplasty in regard to patient satisfaction. Reviewers formally trained in meta-analysis abstraction techniques searched databases and indices using medical subject heading terms and other methods to identify all relevant studies published since 1990. Initially, 3874 citations were identified and evaluated for relevance. Abstract screening produced 112 articles to be read in entirety, of which 47 articles studying 3049 procedures with a mean 61.48 (SD 45.03) month follow-up met all prospective inclusion criteria necessary for analysis. Overall crude patient satisfaction following first MPJ implant arthroplasty was 85.7% (95% confidence interval: 82.5%-88.3%). When adjusting for lower quality studies (retrospective, less than 5 years of follow-up, higher percent of patients lost to follow-up), the overall patient satisfaction increased to 94.5% (89.6%-97.2%) in the highest-quality studies. This adjustment also significantly decreased heterogeneity across studies (crude Q = 184.6, high-quality studies Q = 2.053). Additional a priori sources of heterogeneity were evaluated by subgroup analysis and meta-regression. In regards to patient satisfaction, this comprehensive analysis provides supportive evidence to the clinical benefit of first MPJ implant arthroplasties. LEVEL OF CLINICAL EVIDENCE 1.

The role of combined magnetic field bone growth stimulation as an adjunct in the treatment of neuroarthropathy/charcot joint: An expanded pilot study

This study was designed to assess the value of combined magnetic field (CMF) bone growth stimulation in the treatment of acute, phase 1, Charcot neuroarthopathy. Thirty-one subjects were studied. Initially 10 controls and 11 study patients were examined. When the initial results were analyzed, 10 additional study patients were added. The result was a statistically significant reduction in time to consolidation, 23.8 weeks for the control versus 11 weeks for the study group. Additionally, less destruction of the bony architecture was noted in the study group as compared to the control. Thus the results of this expanded pilot study demonstrate the efficacy of CMF in accelerating the consolidation process of acute, phase 1, Charcot joint, and decreasing the amount of residual deformity.

1995 William J. Stickel Gold Award. High strain rate tissue deformation. A theory on the mechanical etiology of diabetic foot ulcerations

Foot ulcerations are one of the most common and dangerous complications associated with chronic diabetes mellitus. Many studies have focused on neuropathy, in conjunction with elevated ground reactive forces, as the principal cause of these ulcerations. The authors discuss the mechanical cause of diabetic ulcerations at the cellular level. It is hypothesized that increased rate of tissue deformation associated with foot slap secondary to progressive motor neuropathy is the actual culprit, and not the magnitude of local pressure applied. The authors present a cellular model that shows that high rates of tissue deformation may result in elevated intracellular calcium concentrations, which may lead to cellular death, while comparable loads gradually applied do not. Furthermore, there is no significant difference in the response observed at 5 psi and 10 psi. Based on these findings, it is hypothesized that techniques such as ankle foot orthoses, which control the velocity of foot strike, may be useful in treating diabetic foot ulcerations.

Distally based capsule-periosteum interpositional arthroplasty for hallux rigidus. Indications, operative technique, and short-term follow-up.

Twelve patients (15 feet) with severe hallux rigidus underwent distally based capsule-periosteum interpositional arthroplasty of the first metatarsophalangeal joint (mean +/- SD follow-up, 16.8 +/- 7.0 months). Subjective evaluation was based on a modified version of the American Orthopaedic Foot and Ankle Societys 100-point Hallux Metatarsophalangeal-Interphalangeal Joint Scale. Objective evaluation consisted of preoperative and postoperative physical examinations (first metatarsophalangeal joint range of motion and axial grind testing) and radiographic evaluations (joint space width). The short-term results of this novel procedure showed subjective patient improvement and satisfaction, increased first metatarsophalangeal joint dorsal range of motion, maintained hallux plantar range of motion and power, and improved joint space width on anteroposterior and lateral radiographs. None of the patients developed a hallux hammer toe or extensus deformity or lesser metatarsalgia, and none required further surgical intervention. After describing the indications of the procedure and the surgical technique, the authors compare the results with those of the various other procedures available for the surgical treatment of hallux rigidus.

Can synthetic bone models approximate the mechanical properties of cadaveric first metatarsal bone

The authors evaluated the value of plastic foam models for approximating the mechanical properties of cadaveric bone. Three mechanical tests (3-point bending, cantilevered load to failure, screw push-out) were performed to evaluate the performance of fresh (nonpreserved) human metatarsals, plastic solid foam anatomic models, and modified anatomic models. The test results indicate that plastic models may simulate the mechanical properties of natural bone in tests in which only elastic deformation is achieved. However, under circumstances where load is applied until material failure, the mechanical properties vary dramatically. These tests indicate that specific goals should be established with these results in mind, when planning mechanical testing studies with either plastic or cadaveric models.

Diabetic foot ulcers treated with becaplermin and theragauze, a moisture-controlling smart dressing: A randomized, multicenter, prospective analysis

BACKGROUND It is hypothesized that moisture regulation specific to the area of contact results in local wound conditions more amenable to healing, which would result in faster and more frequent wound closure. TheraGauze is a new polymer-impregnated dressing designed to regulate moisture to a varying degree over the entire surface of a wound. METHODS This prospective, randomized, multicenter study examined outcomes from treatment of diabetic foot ulcers with TheraGauze and TheraGauze in conjunction with becaplermin. We also compared these outcomes with historical data from the literature that used saline-moistened gauze and becaplermin. RESULTS The rates of wound closure with TheraGauze and TheraGauze + becaplermin were 0.37 and 0.41 cm(2)/week, respectively (P = .34). The difference between these values was not statistically significant. We also observed high closure rates at 12 weeks (46.2% in both groups) and 20 weeks (61.5% with TheraGauze alone and 69.2% with TheraGauze + becaplermin). These data were also compared with historical data for closure rates (0.18 cm(2)/week) and percentage of wounds closed using saline-moistened gauze alone and becaplermin with saline-moistened gauze (0.24 cm(2)/week) from a variety of studies. CONCLUSIONS Wounds in which moisture content was regulated with TheraGauze showed more rapid change in wound area and a higher percentage of wounds achieving closure at 12 and 20 weeks regardless of whether becaplermin was used.

A retrospective analysis of 22 patients treated with percutaneous radiofrequency nerve ablation for prolonged moderate to severe heel pain associated with plantar fasciitis.

UNLABELLED A retrospective study involving 22 patients (31 feet) with a history of prolonged moderate to severe heel pain associated with plantar fasciitis were examined to determine if ablation of the sensory branch of the medial calcaneal nerve would result in symptomatic relief. Participants in this study were given subjective questionnaires and visual analog scales in order to rate their symptoms before and after nerve ablation using radiofrequency energy. The results showed that the mean preintervention visual analog pain score was 8.12 +/- 1.61 (with 10 being the worst pain the patient could imagine), and this dropped to 3.26 +/- 1.97 after 1 week and 1.46 +/- 1.76 after 1 month, 1.96 +/- 1.98 at 3 months, and 2.07 +/- 2.06 at 6 months, and the improvement was statistically significant (P < .001) at each stage of follow-up. Furthermore, patients followed for up to 1 year showed no significant worsening of symptoms. Adverse events were limited to hematoma at the site of entry of the radiofrequency cannula. These findings support the conclusion that radiofrequency nerve ablation be considered an alternative to repetitive corticosteroid injections or open surgical intervention for the treatment of recalcitrant plantar heel pain. LEVEL OF CLINICAL EVIDENCE 4.

A Retrospective Clinical Study of 188 Consecutive Patients to Examine the Effectiveness of a Biologically Active Cryopreserved Human Skin Allograft (TheraSkin ®) on the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers

A biologically active human skin allograft, currently distributed under the brand name TheraSkin®, was examined for safety and efficacy in the treatment of venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). The objective was to determine if TheraSkin could serve as a safe and effective alternative to bioengineered skin substitutes such as Apligraf® and Dermagraft®. The authors conducted a retrospective study of 214 consecutive patients seen at the Inova Wound Center (Mt Vernon, Virginia), with either a DFU or a VLU. After excluding patients who did not meet the study criteria, the final eligible cohort consisted of 188 subjects, with 134 VLUs and 54 DFUs. Multivariate logistic regression was used to evaluate the relationship between baseline wound size and the proportion of healed wounds after 12 and 20 weeks from initial allograft application. The authors found that by the 12th week, DFUs closed 60.38% of the time and VLUs closed 60.77% of the time. After 20 weeks, the number of closed DFUs increased to 74.1% and the number of VLUs increased to 74.6%. The mean wound size in the DFU group was 6.2 cm2 (±11.8) and 11.8 cm2 (±22.5) in the VLU group. The mean number of TheraSkin allografts required ranged from 1 to 8, with an average of 2.03 (±1.47) at the 12-week point and an average of 3.23 (±2.77) at the 20-week point. Multivariate logistic regression was used to calculate the odds of wound healing by week 12 and week 20 in each group. The authors also analyzed adverse events and found TheraSkin to be noncontributory to any adverse events, verifying the safety of TheraSkin in this study population. In this study, TheraSkin has been shown to be highly effective for the treatment of both VLUs and DFUs with an acceptable safety profile. Level of Evidence: Therapeutic, Level IV