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SynPlug™ |
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SynPlug™ is a cylindrically shaped plug with 5 flanges, intended for intramedullary occlusion during cemented hip arthroplasty. The product range spans intramedullary canal diameters ranging from 8.6 up to 21.5 mm, in 1mm increments.
In summary:
High pressure resistance
Biodegradable
Biocompatible
Synthetic material
Easy instrumentation
High pressure resistance
The unique design of SynPlug (the 5 flanges maximise friction) keeps the restrictor stable, even under high cement pressures, effectively preventing leakage into the distal shaft. Leakage would jeopardize the integrity of the cement-bone and cement-prosthesis interface. SynPlug ensures the longevity of the implant by allowing a homogeneous cement mantle to form around the implant, and increasing the cement penetration into the bone. Independent in-vitro testing has shown that SynPlug, when compared to some PE and Gelatine cement restrictors, provides superior pressure resistance, preventing leakage and migration, and is easy to insert. The hydrophilic properties of the chosen PolyActive™ composition allow the material to expand after implantation.
Biodegradable
SynPlug is biodegradable through the hydrolysis and oxidation of the PEGT/PBT copolymers that constitute PolyActive, making removal during revision surgery in most cases unnecessary. This allows for an easier revision procedure and eliminates the potential risk of PE debris generated by restrictor removal.<
Biocompatible
SynPlug has excellent biocompatibility. The safety and biocompatibility of orthopaedic implants constructed from PolyActive, such as SynPlug, have been studied extensively since 1984, with no reports of adverse reactions. Earlier PolyActive cement restrictor designs have been implanted in over 5,000 patients.
Synthetic material
The chemical formulation used for SynPlug is 1000PEGT70PBT30 PolyActive. PolyActive, a copolymer, consists of 70 per cent by weight poly(ethylene glycol) - terephthalate with a molecular weight of the poly(ethylene glycol) of 1000 and 30 per cent by weight poly (butylene terephthalate). The material exhibits properties of a hydrogel, absorbing up to 0.8 grams of water per gram of material. With no animal derivatives, there is no risk of transferring animal pathogens. SynPlug is injection-moulded and sterilized by gamma irradiation.
Easy instrumentation
The design of the SynPlug instrumentation kit aims at making sizing and insertion simple, fast, and effective. The insertion rod is scaled, allowing for pre-insertion depth calculation, and the probes included in the instrumentation kit provide exact diameter identification. The instrumentation kit has 2 insertion rods and multiple measuring probes, allowing operating room staff easy preparation of instrumentation for diameter identification. The SynPlug instrumentation kit is available in stainless steel or RADEL® (a type of durable plastic) trays. The SynPlug instrumentation kit is delivered non-sterile. |
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