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Delta

Overview

Delta is a resorbable plating system designed for use in the fixation of bone of the Craniofacial and midfacial skeleton affected by trauma, or for reconstruction.

Delta has a polymer composition of 85% poly L-lactide, 10% polyglycolide, and 5% poly D-lactide, contributing to a unique combination of strength, absorption, and contourability.

Features and benefits

Balanced resorption

A unique tripolymer blend of PGA, PLLA and PDLA, provide an ideal resorption profile.

Superior strength

At 2 and 6 months, Delta maintains 78% and 50% of its initial strength respectively, which can help facilitate structural fixation and reinforcement during osteosynthesis.

Torque limiting screwdriver

Feature a unique roller bearing cam, which produces smooth, accurate, and consistent performance when tightening fasteners. When the maximum torque setting is achieved, the cam mechanism automatically slips to prevent over-tightening.

Self-drilling taps

Combine the steps of drilling a pilot hole and tapping into one easy process.

Clinical evidence

Abstract

Background
The malar bone represents a strong bone on fragile support and its processes - frontal, orbital, maxillary and zygomatic are frequently the site of fracture. Current study was done to compare the stability of zygomatic complex fracture using Biodegradable plates and titanium miniplates with one point fixation.

Materials and Methods
Twenty patients of zygomatic complex fracture were randomly selected and divided in two groups which were further divided into two subgroups (A, B). Group I patients were treated with titanium miniplate at zygomatic buttress and Group II was treated by bio-resorbable plates. One point fixation was done either at zygomatic buttress or at frontozygomatic suture and it was observed that both the site have been the most favored site of rigid internal fixation in terms of stability, aesthetics and prevention of rotation of the fracture segment in either vertical or horizontal axis.

Conclusion
There is no significant difference in post operative outcomes between two groups, but still bioresorbable system has some advantage over titanium system as these plates resorbs over a period of time and does not cause any interference with growth and post operative radiotherapy. However application of biodegradable system demands highly précised technique.

Full Article

Abstract

Objective
The aim of this prospective study was to compare the clinical handling of 3 different biodegradable osteosynthesis materials and to determine whether they can be used for the fixation of all types of zygomatic fractures.

Study design
A total of 54 consecutive patients who presented with displaced fractures of the zygomatic bone between October 2001 and May 2003 were randomly allocated to 3 biodegradable material groups for the fixation of the fractures. A titanium fixation system was used as rescue osteosynthesis whenever biodegradable materials failed.

Results
Seventy-one (75.5%) of 94 fracture sites were fixed with biodegradable osteosynthesis; 23 (24.5%) had to be fixed with titanium plates and screws. No statistically significant difference was found between the 3 biodegradable materials with regard to their suitability for zygomatic fracture fixation (P = .16). Nonstable fixation (n = 7) or the need to fix small fragments (n = 16) were the reasons for using the titanium fixation system as rescue osteosynthesis at these sites. Biodegradable materials were most frequently unfeasible for use at the infraorbital rim and in the zygomaticomaxillary/anterior sinus wall area.

Conclusions
It was possible to stabilize 3 of 4 zygomatic fractures with 1.5- or 1.7-mm biodegradable osteosynthesis. Insufficient fracture stabilization, especially at the infraorbital rim and the zygomaticomaxillary crest/anterior sinus wall, was the main reason to switch to titanium osteosynthesis. The biodegradable screw design is possibly too bulky for these particular bony structures.

Full Article

Abstract

Biodegradable plates have been used extensively in fracture fixation since the 1960s. They rarely cause stress-protection atrophy or problems requiring secondary plate removal, common complications seen with metallic plates. However, aseptic foreign-body reactions have been reported, sometimes years after the original implantation. Both inadequate polymer degradation and debris accumulation have been implicated as causes. The current generation of commercial biodegradable plates is formulated to minimize this complication by altering the ratio of polylactic and polyglycolic acids. This in vivo study compares the degree of local foreign-body reaction of two commercially available resorbable plates in rabbits. Two types of biodegradable plates were examined: poly(D/L)lactide acid (PDLLA) and polylactide-co-glycolide acid (PLGA). Each plate was placed into a periosteal pericalvarial pocket created beneath the anterior or posterior scalp of a rabbit. Humane killing occurred at 3, 6, and 12 months postoperatively. Foreign-body reaction was evaluated histologically. The PDLLA plates demonstrated marked local foreign-body reactions within the implant capsule as early as 3 months after implantation, with presence of inflammatory cells and granulomatous giant cells in close association with the implant material. All local foreign-body reactions were subclinical with no corresponding tissue swelling requiring drainage. PLGA plates did not demonstrate any signs of inflammatory reactions. In addition, the PLGA plates did not appear to resorb or integrate at 12 months. Neither PDLLA nor PLGA plates demonstrated inflammation of the soft tissue or adjacent bone outside the implant capsule. In our study, the PDLLA plates demonstrated histological evidence of foreign-body reaction that is confined within the implant capsule, which was not seen with the PLGA plates. This finding may be attributable to the lack of significant resorption seen in the PLGA plates. Both PDLLA and PLGA plates were biocompatible with the rabbit tissue environment and should be considered for continued use in craniofacial, maxillofacial, and orthopedic reconstruction.

Full article

Abstract

Introduction

Several bioresorbable plating systems have become standard in pediatric craniosynostosis reconstruction. A comparison of these systems is needed to aid surgeons in the preoperative planning process. The authors aim to evaluate 1 institution's experience using Resorb-X by KLS Martin and Delta Resorbable Fixation System by Stryker (Stryker Craniomaxillofacial, Kalamazoo, MI).

Methods

A sample of patients with single-suture nonsyndromic craniosynostosis treated at St Louis Children's Hospital between 2007 and 2014 using either Resorb-X or Delta bioresorbable plating systems were reviewed. Only patients with preoperative, immediate, and long-term 3-dimensional photographic images or computed tomography scans were included. A comparison of plating system outcomes was performed to determine the need for clinic and emergency room visits, imaging obtained, and incidence of subsequent surgical procedures due to complications.

Results

Forty-six patients (24 Resorb-X and 22 Delta) underwent open repair with bioabsorbable plating for single suture craniosynostosis. The mean age at each imaging time point was similar between the 2 plating systems (P > 0.717). Deformity-specific measures for sagittal (cranial index), metopic (interfrontotemporale), and unicoronal (frontal asymmetry) synostosis were equivalent between the systems at all time points (0.05 < P < 0.904). A single Delta patient developed bilateral scalp cellulitis and abscesses and subsequently required operative intervention and antibiotics.

Conclusion

Bioabsorbable plating for craniosynostosis in children is effective and has low morbidity. In our experience, the authors did not find a difference between the outcomes and safety profiles between Resorb-X and Delta

Full article

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