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Stephen A Brigido
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ABSTRACT: The orthopaedic device industry is an ever changing market, often guided by creative surgeons who have the common goal of creating a solution to a problem. While being a surgeon-inventor can be both a challenging and rewarding process, there are several steps that the individual must follow to create intellectual property. This article serves as a guide to the novice surgeon-inventor; intended to be used as an early stage reference for those interested in taking their "solution to a problem" to the device industry.
Foot & Ankle Specialist 08/2011; 4(4):256-7.
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Stephen A Brigido
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ABSTRACT: Surgical treatment of damaged soft-tissue structures in the young and physically active patient requires keen understanding of biomechanical forces that are placed on the repair during rehabilitation. Over the years, several materials have been evaluated to mechanically augment suture repair. Autograft tissues such as the gastrocnemius fascia, flexor hallicus longus, peroneus brevis, fascia lata, and plantaris have been implemented successfully. Concerns over donor site morbidity have limited the use of these autologous tissues. Allografts such as fascia lata and tendon have been used successfully but are plagued with practical issues such as inflammatory reaction and suture retention weakness. Acellular regenerative tissue scaffolds have gained in popularity in recent years because of the limited host inflammatory response, ease of use, and high tensile strength.
Foot & Ankle Specialist 10/2009; 2(5):240-4.
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ABSTRACT: The goal of biologic resurfacing is to provide a smooth joint surface with a low coefficient of friction, which allows the joint to function with near normal biomechanics, as well as provide intermittent pressure, to the subchondral and cancellous bone. This unique combination often results in the formation of a "neocartilage-like" structure that can reduce pain and restore biomechanics. As well as giving a brief history of cutis arthroplasty, this article describes cases in which the ankle and first metatarsophalangeal joint underwent biologic resurfacing, with a 2-year postoperative follow up.
Clinics in Podiatric Medicine and Surgery 10/2009; 26(4):633-45.
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ABSTRACT: A novel injectable human dermal matrix has been developed for the treatment of complex diabetic sinus tract wounds. Bioengineered grafts are commercially available that have been somewhat effective in treating chronic wounds such as diabetic foot ulcers; however, these bioengineered grafts are only available in sheet form. These therapies are less effective in treating complex or irregularly shaped wounds that demonstrate tunnels or extensions into deep soft tissue. One acellular graft (GRAFTJACKET, Matrix, Wright Medical Technology, Arlington, Tennessee) that has been shown to effectively treat open wounds is also available in a micronized form (GRAFTJACKET Xpress Scaffold, Wright Medical Technology). This human dermal graft forms a flowable soft tissue scaffold that can be delivered via syringe into tunneling wounds. In this retrospective series, 12 patients with deep tunneling wounds were treated with GRAFTJACKET Xpress Scaffold and followed for 12 weeks. Complete wound healing was achieved in 10 of 12 patients within the 12-week evaluation. The average time to complete healing was 8.5 weeks, whereas the average time to depth healing was 7.8 weeks. The data from the study suggest that this injectable human dermal matrix has unique properties that allow it to facilitate healing of complex tunneling diabetic foot ulcers. The material is easy to prepare and inject into the wound, thereby preventing the necessity of extensive surgical exposure. The matrix supports neo-subcutaneous tissue formation and allows the body to rapidly repair these wounds.
Foot & Ankle Specialist 04/2009; 2(2):67-72.
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ABSTRACT: This multicenter, retrospective study presents the use of a human acellular dermal regenerative tissue matrix as an alternative treatment for 100 chronic, full-thickness wounds of the lower extremity in 75 diabetic patients. Comorbidities included cardiac disease (86.0%), neuropathy (86.0%), peripheral vascular disease (82.0%), infection (54.0%), obesity (51.0%), and osteomyelitis (37.0%). Wound locations included the foot (86.0%), ankle (8.0%), and lower extremity (6.0%). Mean wound age was 20.4 weeks (1.3-191.4 weeks). University of Texas (UT) wound classifications included 15 (15.0%) 1A, 1 (1.0%) 1B, 1 (1.0%) 1C, 2 (2.0%) 1D, 18 (18.0%) 2A, 8 (8.0%) 2B, 5 (5.0%) 2C, 3 (3.0%) 2D, 3 (3.0%) 3A, 7 (7.0%) 3B, 3 (3.0%) 3C, and 34 (34.0%) 3D. The mean time to matrix incorporation, 100% granulation, and complete healing was 1.5 weeks (0.43-4.4 weeks), 5.1 weeks (0.43-16.7 weeks), and 13.8 weeks (1.7-57.8 weeks), respectively. The overall matrix success rate, as defined by full epithelialization, was 90.0%. One failed wound subsequently healed approximately 7 weeks after matrix reapplication. The healing rate was 91.0%, as 91 of the 100 wounds healed. No statistically significant differences were observed between UT classifications and time to matrix incorporation, 100% granulation, and complete healing. Absence of matrix-related complications and high rates of closure in a wide array of diabetic wounds suggest that this matrix is a viable treatment for complex lower extremity wounds. Lack of any statistically significant differences between UT grades and wound outcome end points lends further support to the universal applicability of this matrix, with successful results in both superficial diabetic wounds and in wounds penetrating to the bone or joint.
Advances in skin & wound care 09/2008; 21(8):375-81.
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ABSTRACT: When chronic Achilles tendinosis requires surgical intervention, the repair may often need to be supplemented with graft augmentation. The purpose of this paper is to describe an augmentation reconstruction technique of the Achilles tendon for chronic Achilles tendinosis and the preliminary results achieved using this surgical method. Twenty-one patients with Achilles tendinosis were treated with resection of the diseased tissue, acellular human dermal graft application and early mobilization. Patients were then assessed using a modified American College of Foot and Ankle Surgeons ankle scale preoperatively and 24 weeks postoperatively. Preoperative and postoperative visual analog scale was also reported.
At 24 weeks postoperatively, the patients had an average ankle scale of 77.4/82. Patients were able to return to full activity in 12.1 weeks. Surgical treatment of chronic Achilles tendinopathy with graft augmentation and early mobilization shows good short-term results.
Techniques in Foot & Ankle Surgery 11/2007; 6(4):249-253.
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Stephen A Brigido
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ABSTRACT: A prospective, single-centre, randomized controlled study was performed to evaluate the effectiveness of Graftjacket, a human acellular regenerative tissue matrix as a treatment option for chronic non healing lower extremity wounds. Twenty-eight diabetic patients with full-thickness wounds that had been present for at least 6 weeks were treated with sharp debridement and randomized to a single application of Graftjacket tissue matrix plus mineral oil-soaked fluff compression dressing or to a control treatment of wound gel with gauze dressings. All patients were seen weekly. By week 16, 12 of 14 patients treated with Graftjacket tissue matrix demonstrated complete wound closure compared with 4 of 14 patients in the control group. Patients treated with Graftjacket tissue matrix showed a statistically significant higher percentage of wound healing with respect to wound area, and clinically significant differences in wound depth and wound volume. This comparison is not performed to demonstrate that the application of the Grafjacket is more effective than sharp debridement. This study is done to help assign a role to the use of Graftjacket matrix in lower extremity wound care.
International Wound Journal 10/2006; 3(3):181-7. · 1.46 Impact Factor
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ABSTRACT: Wound healing is a significant problem in orthopedics. Graftjacket tissue matrix (Wright Medical Technology, Inc, Arlington, Tenn), a novel acellular regenerative tissue matrix, has been designed to aid wound closure. A prospective, randomized study was initiated to determine the efficacy of this tissue product in wound repair compared with conventional treatment. Lower extremity wounds are refractile to healing in patients with diabetes mellitus. Therefore, researchers used diabetic foot ulcers to evaluate the efficacy of GraftJacket tissue matrix in wound repair. Only a single administration of the tissue matrix was required. After 1 month of treatment, preliminary results demonstrate that this novel tissue matrix promotes faster healing at a statistically significant rate over conventional treatment. Because wounds in this series of patients are deep and circulation around the wound is poor, the preliminary results suggest that this tissue matrix will be applicable to other types of orthopedic wounds.
Orthopedics 02/2004; 27(1 Suppl):s145-9. · 2.66 Impact Factor
