Phantom® Minimally Invasive Surgery Solution
The Phantom® MIS System was created to support a minimal approach to joint preparation for a Lapidus Arthrodesis procedure. This first-of-its-kind system allows the ability to access the 1st Tarsometatarsal (TMT) joint with minimal disruption to the soft tissue and overlying skin.
Phantom® MIS Lapidus System Overview
A Burr Guide and Paddle allow the surgeon to locate the joint such that the orientation is aligned properly prior to burring
A Ø3.0 mm Shannon-Style Burr is then used to debride the joint, which is designed to avoid impingement of surrounding soft tissue
Phantom® MIS Lapidus System Technique Run-Through
Paddle designed to be inserted into joint space to support proper orientation of the Burr Guide
The Burr Guide is inserted over the Paddle, then temporarily fixated
The Burr Guide is designed to allow a Shannon-Style Burr to sweep through entirety of the joint, once the paddle is removed
Allows for controlled cartilage removal through a minimal (8 mm – 10 mm) vertical incision
See the Phantom® MIS Procedure in Action
Complementary Products
Phantom® Intramedullary Nail
Developed to provide a structurally sound construct that minimizes hardware prominence for the Lapidus Arthrodesis procedure
The uniform force through the nail allows for a stable construct that is intended to promote primary healing throughout the fusion site
Helps preserve periosteum due to the intramedullary construct
The Phantom® Nail may be inserted with a minimum of three stab incisions
Phantom® Nail Implant
Available in 3-hole and 4-hole configurations - length options 38 mm – 60 mm in 2 mm increments
38 & 40 mm
42 & 44 mm
46 & 48 mm
50 & 52 mm
54 & 56 mm
58 & 60 mm
Phantom® Intramedullary Nail Threaded Pegs
Diameter: 3.5mm
Lengths: 10-46 mm (2 mm increments)
Intended Use: Inserts into the proximal holes of Phantom® Nail
Phantom® Intramedullary Nail Locking Screws
Diameter: 3.5mm
Lengths: 10-26 mm (2 mm increments)
Intended Use: Inserts into the most distal hole of Phantom® Nail
How It Works.
The Phantom® Intramedullary Nail was the first intramedullary nail offering from Paragon 28, and offers a unique option for correcting hallux valgus at the 1st TMT joint. The nail and threaded pegs are designed to sit flush in the bone, offering a zero profile construct to minimize the soft tissue disruption of the first metatarsal and medial cuneiform during a Lapidus procedure.
The accompanying instrumentation is designed to provide precise placement and positioning of the nail and pegs reproducibly to potentially save time in the operating room.
With this minimally invasive approach, patients may experience less pain and scarring when compared to traditional repairs.
See the Phantom Nail Implant
Paragon 28® Phantom® Nail Design Rationale
The Phantom® Intramedullary Nail was developed to provide surgeons with an intramedullary option for bunion surgery and correcting hallux valgus at the first TMT joint. The nail and threaded peg construct offer crossed screw fixation proximally and distally, generating a higher compressive force across the fusion site compared to traditional plate and screws¹. The zero profile design reduces soft tissue disruption, plantar gapping, and damage to the periosteum.
The nail is Ø5.5 mm in diameter, available in 12 options ranging from 38 mm to 60 mm in 2 mm increments and available in right and left specific configurations. The system offers Ø3.5 mm threaded pegs and Ø3.5 mm locking screws.
What are surgeons saying about the
Phantom® MIS procedure?
“Other minimally invasive bunion procedures fail to adequately stabilize the joints and may have a high risk of recurrence. The minimally invasive Phantom® MIS procedure combines the benefits of rapid healing and early weight-bearing associated with limited incision surgeries with the proven track record, powerful correction, and low recurrence rate of the traditional Lapidus procedure. We don’t have to compromise: we can benefit from modern surgical techniques without abandoning all the lessons of the past. ”
- Dr. Gregory Guyton, MD | Baltimore, MD
“The Lapidus procedure has been a mainstay in my practice for managing a variety of first ray pathologies. I have employed numerous fixation options to stabilize the first metatarsal cuneiform fusion. The Phantom® Nail is an extremely efficient and effective device for stabilizing the fusion site. The Phantom® Nail literally allows the surgeon to "dial -in" the amount of compression across the fusion site. Stability afforded by the Phantom® Nail may allow patients to start partial weight bearing earlier.”
- Dr. Ronald Ray, DPM | Great Falls, MT
“I have been fixing HAV deformities for over 30 years. My procedure of choice is the Lapidus correction. Stabilization of this operation has been historically challenging until recently! Now with the availability of the Paragon 28® Phantom® Nail the fixation has been streamlined.
Not only does the application require less medial dissection preserving the tibialis anterior attachment completely, it also enables the surgeon to completely fix the fusion site in a matter of minutes. The system allows for significant compression which in turn enables much earlier post-operative weight bearing. This product has changed my patients’ experience in a major way.”
- Dr James Clancy, DPM | Palm Beach, FL
“A bunion is a very complex problem, and sometimes it is difficult to fix.
In my opinion, most bunions should be fixed with a Lapidus bunionectomy, which is a fusion of the 1st metatarsal to the 1st cuneiform bone. This is a difficult surgery to perform, and the Phantom® Nail makes the surgery much easier and more successful.
Because it can be difficult to get the bones to fuse, surgeons through the years have literally tried dozens of different screw and plate combinations. Often, these plate combinations are bulky and thick, therefore, even if the bone fuses properly, the patient can often feel the irritating plate through the skin postoperatively. The plate almost always sits right in an area that most shoes rub against; this necessitates a 2nd surgery to remove the hardware.
The Phantom® Nail is entirely under the surface of the bone. It is strong, it provides very secure fixation (better than any plate on the market), yet it is never felt through the skin after surgery. I have never had to remove a Phantom® Nail after a successful bunion surgery.
I exclusively use the Phantom® Nail in all of my Lapidus bunion surgeries; I believe it is the best system for this particular complex surgery. ”
- Dr. Jason Bruse, DPM FACFAS | Layton, UT
“For the longest time, we've been trying to fix bunions by doing distal metatarsal osteotomies or shaving off the bump and getting less than desirable results. Then the Lapidus procedure came out which is a much more powerful corrective procedure to fix those stubborn bunions, but the standard way to fix them is with 2 cross screws and non-weight bearing for a minimum of 6 weeks. So what does Paragon 28® do? They take it to the next level! How? By adding an intramedullary nail that powerfully fixates the fusion site with ridiculous amounts of compressive exuding "fusion juice" and then on top of that has screws that are buried in the bone so you don't feel any screw heads. The construct is so solid that it allows my patients to weight bear much earlier and return quicker to regular shoes and activity. The Paragon 28® Phantom® nail is now my "go-to" for the Lapidus procedure. This system should be on the top of your list when you do the Lapidus bunionectomy. Give it a try...you won't be disappointed!”
- Dr. Hai-En Peng, DPM, FACFAS | Camarillo, CA
“I have been performing bunionectomies for the past 25 years, having utilized the numerous procedures and fixation choices that have been available. The culmination of this work is the realization that the Lapidus bunionectomy is still the best procedure to treat bunions, and the Paragon 28® Phantom® Nail is the best hardware for this surgery.
The Lapidus procedure addresses the bunion where it begins, the 1st metatarsal-cuneiform joint. The other procedures simply do not provide the power and long-term results of the Lapidus.
Paragon 28®’s Phantom® Nail is the superior method of fixation. Before this product, various methods have been used including numerous screws and various plates. They do not provide the same stiffness, compression, or rigidity of the Paragon 28® Phantom® Nail. A second surgery to remove hardware is not necessary, because the Paragon 28® Phantom® Nail is recessed in the bone. There are no under the skin plates or screws that will bother the patient later.
The re-emergence of minimal incision bunionectomies has pushed the boundaries of bunion repair beyond what is reasonable, but with the Paragon 28® Phantom® Nail, you can use it through an open or minimal incision technique. The Paragon 28® Phantom® Nail has changed my practice.
My patients are walking sooner, experiencing less pain and swelling, and are getting back to work and activities far earlier than the past. I exclusively use this system for my Lapidus bunionectomies, providing more consistent and successful outcomes.”
- Peter Lallas DPM, FACFS | Kirkland, WA
“The Lapidus arthrodesis has been one of our most common interventions for many years. The results of the procedure are excellent both in the correction of large hallux valgus deformities and in the symptomatic instability of the 1st ray, often combined with transfer metatarsalgia.
The Phantom Intramedullary Nail, one of the latest biomechanically and most sophisticated fixation systems, combines the proven physical advantage of an intramedullary nail and a very strong force carrier with a 5.5mm diameter, allowing the patient to be subject to a pain-adjusted full weight-bearing immediately after the procedure. Since the system considers the latest biomechanical findings on the pathologies of the first ray and 3-dimensional correction in the preparation steps, the nail combines all the advantages that can be expected from an implant, in my opinion on the highest level. Furthermore, there are no hardware problems or shoe conflicts as the implant is completely intraosseous with an option of a minimally invasive inserting technique and thus less soft tissue disruption and less scarring for the patient.
In our center, we have been systematically evaluating over a defined period and observed very good correction results, consistent with all surgeons, with lower complication rates compared to other systems, and high patient satisfaction due to the lack of hardware problems and the immediate pain-adapted mobilization. The Phantom Nail system has become one of our standard procedures.”
- Dr. Daniel Thull | Cologne, Germany
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Sources
1) Test Report (TR-17060501) on file at Paragon 28®
For the contraindications, potential complications and adverse reactions, warnings and precautions associated with this device, please refer to the device specific instructions for use here.