Year in Review: Fixation 2011

2011 was a year of mergers & acquisitions ultimately making the most headlines in the world of foot and ankle fixation news. This all started with the monster mega merger between Depuy Orthopedics and Synthes back in April. Before the dust even had a chance to settle, the acquisition of MMI by Stryker and then Ascension Orthopedics by Integra LifeSciences made headlines. Zimmer made a splash by acquiring the external fixation line ExtraOrtho and finally Wright Medical also joined in the fun by agreeing to carry ArthroCare's Opus Knotless suture fixation technology. The acquisition of these new technologies and expansion of the product lines certainly has influenced the playing field among the "Big" companies who are vying for the majority of the Foot & Ankle market share. Only time will tell who the winners and losers are by how the market responds to these changes and particularly where surgeon loyalty falls.

In light of last years chess match between some of the largest medical device companies, out of the ashes came a handful of new companies and product lines…

For starters, Arrowhead Medical Device Technologies brought forth the Arrow-Lok hammertoe implant. This implant eliminates the need for external k-wire fixation nor does it need any form of temperature control prior to or after insertion of the implant. The company is currently in the process of developing their next foot and ankle implant. Other companies new to the foot and ankle market include Solana Surgical, whose focus in currently on 1st MPJ implants; Nextremity Solutions, who is in the process of bringing forth the Nextra Hammertoe Correction System, and Paragon 28, who will be offering a complete line of forefoot, midfoot and hindfoot plates.

Some of the new products to hit the market this past year introduced traditional concepts with a new twist. The Stryker (formerly MMI) Anchorage CP Plate was the first plate of it's kind, allowing surgeons

the ability to introduce an interfragmental compression screw actually through a dedicated screw hole. The new plates were specifically designed for a 1st MPJ Arthrodesis and Lapidus Arthrodesis. The Arrow-Lok implant previously mentioned takes the traditional buried k-wire fixation concept and augments it with the added benefit of greater pullout strength from the double-ended arrow tips. Other new products to highlight the year include the Pro-Toe VO

& Inbone II Total Ankle Replacement by Wright Medical, the BME Speed, the Integra U-Shaped Plate, and the Arthrosurface HemiCap Talar Resurfacing Implant (which at this time is still not yet available for use in the U.S.) As new products hit the open market, there was a trend in that Ankle Implants and Hammertoe Implants were definitely the hottest fixation of 2011

Probably the most exciting news though of 2011 for foot and ankle surgeons was the inaugural year of FootandAnkleFixation.com! No longer will surgeons have no place to look for updated and relevant foot and ankle surgery information for your daily practice and patients. Too many other orthopedic websites focus on the corporate aspect of medical device information, where our information is dedicated to the driving force behind it all, the actual fixation devices and how it relates to the surgeon's practice. By surgeons, for surgeons.

So what's on the horizon for 2012? Stay tuned to FootandAnkleFixation.com to keep up with the latest unbiased foot and ankle fixation news.

Evolution of the Locking Plate

As locking plates emerged over the past decade, new advances and technologies have continued to evolve. Looking back, it’s hard to forget the classic AO video demonstrating pullout strengths between locking and non-locking 3.5mm cortex screws while applying a cloverleaf plate to an apple. As if the video wasn’t convincing enough, numerous studies and publications further backed the increased stability achieved with the locking constructs. Needless to say, interest in locking plates steadily grew as they became sought after particularly in cases of unstable trauma, revisional surgery and osteopenic bone.

With major companies like Synthes leading the way with newer locking technology, along came the locking drill guide. This added precise accuracy when pre-drilling. Now the drill hole would maintain a centralized position aligning and locking the screw properly with the plate threads. Simple enough right? Not exactly. Problems can still arise

· Alteration of the locking construct following bending of the plate

o Likely the most common cause of problems

o Inherently alters the integrity of the plate threads disrupting the screw from seating properly within the plate.

· Not inserting the screw directly 90 degrees to the plate

o The screw head will not seat properly within the plate

o Can cause the metal to strip or peel off the head

o If enough force is applied, the head of the screw can actually break off

These downfalls can lead to failure with the locking construct and/or neutralize their locking effect, essentially making them no stronger than a non-locking plate. Fast forward to today. New advances in locking plate technology have evolved such that it gives the surgeon additional room for error when applying a locking plate.

Examples:

· The Depuy plating systems

o Pre-loaded locking guides on the plates

- Eliminates the sometimes frustrating step of trying to get the drill guide to properly load into the plate

- Enables the surgeon the ability to bend the plate without disrupting the plate threads

· Smith & Nephew plates

o Variable angle capabilities.

o Now the screw does not need to be directed in precisely at 90 degrees

Some plates have eliminated the need for threads within the plate holes altogether:

· Extremity Medical IoFix Implant

o Although not a plate per say, the IoFix implant utilizes the locking plate idea. Based on the conical shape of the screw head, the screw essentially locks into the post as it is inserted.

· Integra Hallu-Lock Plate

o Utilizes a SurFix system

- There are no threads on the head of the screw

- Instead, a separate threaded washer, applied on top of the screw head, after the screw is inserted

Can traditional non-locking plates get the job done? Probably in most cases, yes. Do locking plates offer multiple advantages over standard plating options? Most definitely. Ultimately, the choice to use these new plating options rests in the hands of the surgeon. Regardless, advances in plating technology have and will continue to evolve, making it not only easier for the surgeon but also superior for the patient.

- www.FootandAnkleFixation.com

It's Official: Integra & Ascension Merger

As previously reported on FootandAnkleFixation.com, Integra LifeSciences and Ascension Orthopedics entered into an agreement to merge under the Integra Brand on September 12, 2011. Now it's Official.

Per their website, Integra has announced that the merger is complete and the Ascension line of foot and ankle products are currently being integrated in with their product line. In addition to the plating and screw systems, this acquisition will bolster Integra’s foot and ankle product line to include pryocarbon technology, specifically with the PryoSphere TMT implant for Lisfranc Joint Arthrodesis.

As this merger continues to evolve, FootandAnkleFixation.com will continue to bring you the latest news and information involving their foot and ankle product lines. Stay tuned for more information.

New Integra U-Shaped Plate

Integra has announced the release of a new U-Shaped compression plate that will augment thier Uni-CP Compression System. The new 4-hole U-Shaped plate will come in three sizes and is designed for arthrodesis at the second and third metatarsocunieform joints. The plate has been approved by the FDA in the U.S. as well as it has received a CE Mark Certification in the Europe.

"The new line extension is a very exciting opportunity for Integra," said Pete Ligotti, Vice President, Marketing, Integra Extremity Reconstruction. "The U-shape plate is an innovative approach to fixation of the second and third metatarsal cuneiform joints. It comes in three sizes, which gives surgeons a significant addition to their armamentarium, and helps limit uncertainty by accommodating a patient's unique treatment needs."

The new plate will be up on www.footandanklefixation.com as soon it is live online. You can see the current Integra products as well as the Uni-CP Compression System here.