Prospective, Multicenter, Clinical and Radiographic Evaluation of a Biointegrative, Fiber-Reinforced Implant for Proximal Interphalangeal Joint Arthrodesis

Luke D Cicchinelli, Jurij Štalc, Martinus Richter, Stuart Miller, Luke D Cicchinelli, Jurij Štalc, Martinus Richter, Stuart Miller

Abstract

Background: A novel biointegrative implant was developed for proximal interphalangeal joint (PIPJ) arthrodesis to treat hammertoe deformity. Composed of continuous reinforcing mineral fibers bound by bioabsorbable polymer matrix, the implant demonstrated quiescent, gradual degradation with complete elimination at 104 weeks in animal models. This prospective trial assessed the implant's safety, clinical performance, and fusion rate of PIPJ arthrodesis for hammertoe correction.

Methods: Twenty-five patients (mean age 63.9±7.5 years) who required PIPJ arthrodesis were enrolled at 3 centers. Outcomes included radiographic joint fusion, adverse events, pain visual analog scale (VAS) score, Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) score, and patient satisfaction. Patients were evaluated 2, 4, 6, 12, and 26 weeks postoperatively.

Results: Twenty-two patients (88%) achieved radiographic fusion at 26 weeks. All joints (100%) were considered clinically stable, with no complications or serious adverse events. Pain VAS improved from 5.3±2.5 preoperatively to 0.5±1.4 at 26 weeks postoperatively. FAAM-ADL total scores and level of functioning improved by mean 19.5±19.0 points and 24.4±15.7 percentage points, respectively, from preoperation to 26 weeks postoperation. Improvements in pain VAS and FAAM scores surpassed established minimal clinically important differences. All patients were very satisfied (84%) or satisfied (16%) with the surgery. Patient-reported postoperative results greatly exceeded (72%), exceeded (20%), or matched (8%) expectations.

Conclusion: This prospective, multicenter, first-in-human clinical trial of a novel biointegrative fiber-reinforced implant in PIPJ arthrodesis of hammertoe deformity demonstrated a favorable rate of radiographic fusion at 12 and 26 weeks, with no complications and good patient-reported clinical outcomes.

Level of evidence: Level IV, prospective case series.

Keywords: arthrodesis; bioabsorbable; continuous mineral fibers; deformity; fusion; hammertoe.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Luke D. Cicchinelli, DPM, reports personal fees from Ossio Ltd. (Israel), grants from Ossio Ltd. (Israel), during the conduct of the study. Jurij Štalc, MD, reports other from OSSIO Ltd. (Israel), during the conduct of the study. Martinus Richter, MD, PhD, and Stuart Miller, MD, report personal fees from OSSIO Ltd. (Israel), during the conduct of the study. ICMJE forms for all authors are available online.

© The Author(s) 2020.

Figures

Figure 1.
Figure 1.
Patient disposition chart.
Figure 2.
Figure 2.
(A) The biointegrative, fiber-reinforced hammertoe fixation implant used in this study has a hexagonal cross-section of 2.9 mm. (B) Scanning electron microscope cross section of implant demonstrates continuous mineral fibers surrounded by polymeric material.
Figure 3.
Figure 3.
Hammertoe correction procedure. (A) The implant is inserted into the proximal phalanx. (B) Implantation into the proximal phalanx is completed. (C) The middle phalanx is mounted onto the distal end of the implant.
Figure 4.
Figure 4.
Weightbearing radiographs of a 68-year-old woman presenting with a hammertoe deformity of the second toe in the right foot. Preoperative radiographs: (A) lateral oblique, (B) lateral, and (C) dorsoplantar views. Postoperative radiographs at (D) 2 weeks, (E) 12 weeks, and (F) 26 weeks, demonstrating union.
Figure 5.
Figure 5.
Postoperative computed tomographic scans of the second toe of a 59-year-old woman, at 26 weeks following proximal interphalangeal (PIP) joint arthrodesis, demonstrating union: (A) sagittal and (B) coronal axes.
Figure 6.
Figure 6.
Pain visual analog scale (VAS) scores preoperatively and at weeks 2, 4, 6, 12, and 26 postoperative (n = 25).

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Source: PubMed

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