A bio-integrative fiber-reinforced implant (OSSIOfiber® Hammertoe Fixation Implant, OSSIO Ltd., Caesarea, Israel) for proximal interphalangeal joint (PIPJ) correction-arthrodesis showed partial ...bio-integration at 1-year follow-up (1FU) in a previous study. The study was prolonged to assess the bio-integration at 2-year-follow-up (2FU).
Twenty-four patients with proximal interphalangeal joint (PIPJ) correction-arthrodesis using the fiber-reinforced implant and analysed at 1FU, completed 2FU. Follow-up included clinical examination, patient reported outcomes, radiographs, MRI and bio-integration scoring. Results were compared between the 1FU and 2FU (paired t-test).
Radiographs confirmed fusion in 96 % (n = 23) at 2FU (1FU, 92 % (n = 22)). Implant was no longer visible in 21 % (n = 5), partially visible in 33 % (n = 8), and fully visible in 46 % (n = 11)(1FU, fully visible 100 % (n = 24)). The border between implant and surrounding bone was scored not visible in 88 % (n = 21) and partially visible in 12 % (n = 3) (1FU, border partially visible 100 % (n = 24)). There were no cyst formation or fluid accumulation findings 1FU/2FU. Mild bone edema was detected in 4 % (n = 1) (1FU, 29 % (n = 7)). None of the edema findings were considered as adverse implant related. The mean bio-integration score was 9.71 ± 0.69 at 2FU (1FU, 7.71 ± 0.46). The parameters of border between implant and bone and bone edema further improved at the 2FU compared to the 1FU, total bio-integration score was also higher at 2FU than 1FU (each p < 0.05).
This study demonstrates 96 % PIPJ fusion rate and increased bio-integration from 1FU to 2FU, reaching advanced bio-integration of the fiber-reinforced implant at 2FU.
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.
Category:
Midfoot/Forefoot; Lesser Toes; Other
Introduction/Purpose:
Bio-integrative implants, uniquely designed with high mineral fiber content, were developed to encourage paced, gradual ...degradation while enhancing bio-integrative response. Previous publications demonstrated the safe use of these fiber-reinforced implants in both in vivo preclinical models and in clinical use. The main focus of this study was to assess the longer-term clinical outcomes and to evaluate implant bio-integration, using a newly developed Magnetic Resonance Imaging (MRI) scoring system. The device used in this study was a Proximal Interphalangeal Joint (PIPJ) fixation implant. The scoring system implemented in this study was developed based on the review of existing literature describing MRI evaluation of degradable orthopedic implants, concentrating on various local tissue reactions and the implant-to-bone interphase characteristics.
Methods:
Twenty-four patients were enrolled in this multicentre study, all previously treated for a single hammertoe deformity using the fiber-reinforced, bio-integrative fixation implant. Implant material is composed of continuous reinforcing mineral fibers (SiO2, Na2O, CaO, MgO, B2O3, and P2O5), bound together by a degradable polymer poly (L-lactide-co-D,L-lactide), PLDLA) in a 50% w/w ratio. Final study visit took place two years post-operatively. X-ray was used to assess radiographic PIPJ fusion, defined as at least 50% bridging across the osteotomy site. MRI scans were reviewed by an independent radiologist, using a newly developed bio-integration score on a scale of 0-10. The score focused on material bio-integration defined by the evaluation of implant and bone border visibility, and parameters for local tissue response; fluid accumulation, cyst formation and local bone edema. Patient Reported Outcomes of Visual Analogue Scale (VAS) for pain, were also collected. Results were analysed and compared to previously published data.
Results:
Radiographic PIPJ fusion rate was 96% (n=23) at the 2-year follow-up. MRI was performed and analyzed for all patients. The border between implant and surrounding bone was scored as not visible in 88% of subjects (n=21) and partially visible in remaining 12% (n=3) (100% partially visible at the 1 -year). Mild bone edema was detected in 4% (n=1) (29% at 1-year). The edema findings were not evaluated as adverse implant-related. There were no cyst formation or fluid accumulation findings. The mean bio-integration score was 9.70+-0.69 at the 2-year timepoint (7.71+-0.46 at 1-year). Patient reported outcomes showed improvement from baseline with pain score reduced to 0.04+-0.20 compared to the initial score of 5.3+-2.5 at screening. No implant-related adverse effects were reported.
Conclusion:
Study results provide evidence of safe bio-integration of the fiber-reinforced implants, with favourable clinical outcome at 2-years follow-up. MRI scans did not detect fluid accumulation, cyst formation or adverse implant-related edema findings. Primarily, these study results represent a first longer-term follow-up for these implants in a clinical setting. The advanced bio-integration results at 2-years corelate well with substantial degradation previously demonstrated in animal models at a similar timepoint. Proven to provide the mechanical strength and safe elimination of the material without adverse local inflammation, this technology shows promising potential to be implemented on broader applications in orthopaedic surgery.
A new bio-integrative fiber-reinforced implant (OSSIOfiber® Hammertoe Fixation Implant, OSSIO Ltd., Caesarea, Israel) was developed for proximal interphalangeal joint (PIPJ) correction-arthrodesis. ...The main purpose of this clinical study was to assess implant bio-integration at 1-year follow-up.
Twenty-four patients, previously treated for a Hammertoe deformity using the bio-integrative, fiber-reinforced implant, were enrolled in this follow-up study. One-year follow-up included clinical examination, patient reported outcomes, radiographs, Magnetic Resonance Imaging (MRI) and bio-integration scoring.
Proximal interphalangeal joint (PIPJ) radiographic fusion rate was 92% (n = 22). MRI was analyzed for 24 (100%) patients. In 100% of patients (n = 24), the border between implant and surrounding tissue was scored as partially visible. There were no cyst formation or fluid accumulation findings. Mild bone edema was detected in 29% (n = 7) and is attributed to the chronic distribution of forces due to chronic abnormal gait and pasture. None of the edema findings were considered as adverse implant-related finding. The mean bio-integration score was 7.71 ± 0.46.
This study demonstrates safe bio-integration of the newly developed fiber-reinforced implant at 1-year follow-up without negative side effects.
Every wound is contaminated, but not all wounds end with a prosthetic joint infection (PJI). The pathogenic process involves bacterial adhesion steps that are fundamental in the early stage of PJI ...development and the consecutive biofilm formation. Biofilm development is an essential step in establishment of a chronic PJI. Due to its physical and chemical proprieties, it serves as a basic structure that protects bacteria from environmental influences like host immune defenses and antibiotics. To understand the diagnostic principles and treatment modes, it is imperative to understand the basics of the pathogenesis of PJI.
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