Publications

Haggerty EK, Chen S, Thordarson DB.

Foot & Ankle International. 2020;41(2):183-186.

A retrospective review of 81 consecutive patients who underwent either a medial or lateral calcaneal slide osteotomy with a Gorilla® Calc Slide Plate by a single surgeon was conducted.  All patients achieved union with no cases of symptomatic hardware.  1 of 81 patients (1.2%) underwent hardware removal after union due to wound breakdown.

Related Product: Gorilla® Calc Slide Plate

Stenquist D, Velasco BT, Cronin PK, Briceño J, Miller CP, Riedel MD, Kwon JY

Foot & Ankle Specialist. 2020; 13(5), 397-403.

A retrospective review of 18 consecutive patients (with 24 screws) who underwent syndesmotic fixation utilizing a Paragon 28® R3LEASE™ screw was conducted.  Mean follow-up was 11.7 months (range: 6.0-14.7 months). 5 of 24 R3LEASE™ screws were broken at an average of 154.8 days (range: 80-196 days) after implantation.  All 5 R3LEASE™ screws broke at the intended break point.  There was no syndesmotic diastasis, mortise malalignment, or surgical complications.  No R3LEASE™ screws were removed.

Related Product: R3LEASE™ Stabilization System

Wagner P, Wagner E

Foot & Ankle Orthopaedics. 2018; 3(3)

Twenty-five patients (30 feet) who underwent hallux valgus correction with the Proximal Rotational Metatarsal Osteotomy (PROMO) technique were prospective followed for an average of 12 months. Patients were allowed to bear weight immediately, as tolerated.  100% of the patients were satisfied with the procedure.  Radiographic and functional improvements were found. One patient did not have complete rotational correction.  There were no infections, deep venous thrombosis, or radiologic recurrence at final follow-up.

Related Product: PROMO™ Triplanar Hallux Valgus Correction System

Wagner P, Wagner E

Foot and Ankle Clinics. 2018; 23(2), 205-217.

The authors provide commentary on how the rotational deformity influences their procedure choice for hallux valgus correction and discuss when they use a Proximal Metatarsal Rotational Osteotomy (PROMO) technique.  Results on 25 patients with average follow-up of 1 year showed improved lower extremity function with no recurrences, complications, secondary metatarsalgia, dorsal malunion, or metatarsal shortening.

Related Product: PROMO™ Triplanar Hallux Valgus Correction System

Wallace SB, Hunt KJ

Techniques in Foot & Ankle Surgery. 2021

The authors provide a technique guide for their preferred Proximal Rotational Metatarsal Osteotomy system, the Paragon 28® PROMO Triplanar Hallux Valgus Correction System.  The authors note that patients are made non-weight-bearing in a splint for 1 to 2 weeks, followed by a walking boot for 6 weeks.   A sample case is provided with no deformity recurrence at 1 year.

Related Product: PROMO™ Triplanar Hallux Valgus Correction System

Wagner P, Wagner E

JBJS essential surgical techniques. 2019; (9)4

The authors provide a technique guide for the Proximal Rotational Metatarsal Osteotomy system using the Paragon 28® PROMO Triplanar Hallux Valgus Correction System.  A narrated surgical video is provided with commentary on the procedure, results, and post-operative protocol.

Related Product: PROMO™ Triplanar Hallux Valgus Correction System

Wagner P, Wagner E

Foot and ankle clinics. 2020; (25)1, 69-77

The authors discuss the coronal plane deformity associated with hallux valgus and some of the surgical options used to treat the deformity.  Clinical outcomes on the Proximal Rotational Metatarsal Osteotomy are reported on 60 patients with 1 year of follow-up and 25 patients with 2 years of follow-up.  Two cases of deformity relapse were seen. There was 1 delayed union that progressed to union at 3 months.  No infections were seen.

Related Product: PROMO™ Triplanar Hallux Valgus Correction System

de Cesar Netto C, Schmidt EL, Lalevee M, Mansur NSB

Archives of Orthopaedic and Trauma Surgery. 2021; 1-13

A flexor tenodesis procedure is described using the Paragon 28® TenoTac™ Soft Tissue Fixation System. Three lesser toe deformity case summaries are presented with average follow-up of 6.3 months.  All patients showed improved patient reported outcome scores.  The authors report good clinical and radiographic correction with no complications related to the implant or technique.

Related Product: TenoTac® Soft Tissue Fixation System

Prieto-Diaz C, Anderle MR, Brinker LZ, Allard R, Leasure J

Foot & Ankle Orthopaedics. 2019; 4(4)

A biomechanical experiment was conducted on forty cadaver specimens that received 1 of 4 operative treatments: a Phantom® Intramedullary Nail with 2 points of fixation in the cuneiform, a Phantom® Intramedullary Nail with 1 point of fixation in the cuneiform, a Gorilla® Lapidus plate, or 2 crossing screws.  Both versions of the Phantom® Intramedullary Nail, and the Gorilla® Lapidus plate resisted plantar gapping better that two crossing screws.

Related Products:

Phantom® Intramedullary Nail

Gorilla® Lapidus Arthrodesis System

Bean B, Mangold DR, Abousayed M, Coleman MM, Thompson J, Guyton G

Foot & Ankle Orthopaedics. 2022; 7(1)

A retrospective review was conducted on the first 30 consecutive percutaneous MIS-modified Lapidus procedures by a single surgeon utilizing the Phantom® Intramedullary Nail.  Pain scores, IMA, and HVA all improved from pre-operative to post-operative.  There were no intraoperative complications, or post-operative wound complications, surgical site infections, hardware complications, transfer metatarsalgia, or nerve-related problems.  There was 1 case of hallux valgus recurrence and 1 nonunion which required revision.

Related Product: Phantom® Intramedullary Nail

Anderle MR, Obert RM, Paxson RD, Brinker LZ, Clancy JT

Foot and Ankle Surgery. 2021; 27(7)

Weightbearing CT scans were used to analyze the sagittal curvature of the talar dome and distal tibia in 18 healthy subjects. The curvature at four anatomic regions (Lateral Posterior, Medial Posterior, Lateral Anterior, and Medial Anterior) was found. For the talus, the medial anterior radius was smaller than the lateral anterior radius. For the distal tibia, the lateral posterior radius was smaller than the medial posterior radius. The most common geometric configuration was two cones, one anterior and one posterior, pointed in opposite directions.

Related Product:
APEX 3D™ Total Ankle Replacement System

de Cesar Netto C, Ehret A, Walt J, Chinelati RM, Dibbern K, de Carvalho KA, Tazegul TE, Lalevee M, Mansur NS

Archives of Orthopaedic and Trauma Surgery. 2022 Mar 21:1-3.

Outcomes from 22 patients who underwent a LapiCotton procedure with a PRESERVE™ Lapidus Angular Length Restoring Graft were reported.  Intra-operatively, trial sizers were used to determine the appropriate size of the graft.  The median size of the PRESERVE™ graft used was 8 mm (range: 5-19 mm).  A variety of fixation methods were employed. At 3-months post-op, 91% of the subjects (20/22 subjects) achieved complete healing of both surfaces of the fusion site.  Statistically significant improvement was seen in the talus-first metatarsal angle from pre-operatively to post-operatively (p<.0001). One patient required reoperation.

Related Product: PRESERVE™ Bone and Biologic Solutions

Ciufo DJ, Grant AM

Techniques in Foot & Ankle Surgery, 21(1), 40-47.

The authors share a technique for TTC arthrodesis using the anatomically contoured Silverback™ TT/TTC Plating System. Four cases are summarized with two of the cases presented in detail.  All patients went on to fusion and were satisfied with the procedure.  All patients reported pain scores of 0 or 1 (out of 10) at the most recent follow-up. No reoperations were required. One subject had plantar nerve pain after the procedure which gradually decreased over time.

Related Product:
Silverback™ TT/TTC Plating System

Gadomski BC, Labus KM, Stewart HL, Bisazza KT, Nelson BB, Puttlitz CM, McGilvray KC, Regan DP, Easley JT

Frontiers in Veterinary Science. 2022;9.

A novel large animal model was developed for the investigation of foot and ankle implants. 8 sheep underwent ligament resection and subsequent stabilization with canulated Mini-Monster® Screws. 2 additional sheep served as controls.  4 of the surgically stabilized animals were sacrificed at 6 weeks and the remaining four at 10 weeks. Arthritic changes were noted in 1/8 (12.5%) carpi at 6 weeks and 2/12 (17%) at 10 weeks. Histomorphometry showed bridging and reconnection of 5/8 (62.5%) ligaments at 6 weeks and 7/8 (87.5%) ligaments at 10 weeks.

Related Product:
R3ACT™ Stabilization System

Heifner JJ, Rodriguez Materon S, Zhang L, San Giovanni TP,

The Journal of Foot and Ankle Surgery, 2022

A retrospective review was conducted on 91 feet (80 patients) who underwent 1st TMT arthrodesis with and without a PRESERVE™ Lapidus Angular Length Restoring Graft in conjunction with a medial locking plate (Gorilla® Lapidus Plates) or screw fixation.  Union was assessed via CT at an average of 15.5 weeks post-op. Union rates were not significantly different between patients who received a PRESERVE™ graft compared to those who did not (90% vs 97%, p=0.41).  Union rates were significantly higher for the medial plate group compared to the screw fixation group (98% vs 85%, p=0.04).

Related Products:
PRESERVE™ Bone and Biologic Solutions
Gorilla® Lapidus Arthrodesis System

Clarke GA, Johnson JE, de Cesar Netto C, Anderson DD

American Orthopaedic Foot & Ankle Society Annual Meeting, 2023

Finite element analysis (FEA) was used to evaluate micromotions of the tibial component of the APEX 3D(TM) Total Ankle Replacement System.  The findings suggest that patient-specific differences in bone density impact implant behavior.  Differences due to bone quality were diminished when interference fit was modeled. Interference press-fit has dominant effect on implant stability.

Related Product:
APEX 3D™ Total Ankle Replacement System

Clarke GA, Johnson JE, de Cesar Netto C, Anderson DD

American Orthopaedic Foot & Ankle Society Annual Meeting, 2023

Finite element analysis (FEA) was used to evaluate implant-bone micromotion for tibial component of TAR implant designs. Differences between implant designs largely disappeared when tibia sidewalls and interference fit were introduced.

Related Product:
APEX 3D™ Total Ankle Replacement System

Johnson JE, Clarke GA, de Cesar Netto C, Anderson DD

Journal of Orthopaedic Research, 2024;1-9

Finite element analysis (FEA) was used to investigate factors influencing implant‐bone micromotion in TAR. Differences between implant designs largely disappeared when tibia sidewalls and interference fit were introduced. The results offer novel insight into the effect of TAR fixation features and the associated micromotion at the implant‐bone interface in two patients with representative bone density in their distal tibia.

Related Product:
APEX 3D™ Total Ankle Replacement System