Fiber-reinforced fixation implant for proximal interphalangeal joint arthrodesis shows advanced implant bio-integration at 2-year follow-up.

BACKGROUND: 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). METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.

Fiber-reinforced fixation implant for proximal interphalangeal joint arthrodesis shows implant bio-integration at 1-year follow-up.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: This study demonstrates safe bio-integration of the newly developed fiber-reinforced implant at 1-year follow-up without negative side effects.

A 28-Year-Old Woman with Down Syndrome, Congenital Heart Disease, and a History of Knee Surgery and Plantar Fasciitis, with Hallux Abducto Valgus (Bunion) and Lapiplasty Three-Dimensional Correction Surgery.

BACKGROUND Tarsometatarsal joint (TMJ) arthrodesis is common method used for correcting hallux abductus valgus (HAV). Its popularity has grown due to studies revealing HAV's triplanar deformity with frontal plane rotation. This case report presents a 28-year-old woman with Down syndrome, congenital heart disease, and a history of knee surgery and plantar fasciitis, with severe HAV deformity and flexible valgus flatfoot associated with ligamentous hyperlaxity. CASE REPORT Examination revealed severe foot deformities, and radiographic studies confirmed the condition. A surgical intervention was planned, and the patient's cardiologist confirmed she was fit for the procedure. The modified Lapidus technique with frontal plane rotational correction included realigning the metatarsal joint, resecting spurs, osteosynthesis material, and arthrosis in the sinus tarsi. After surgery, the patient underwent a recovery period without support for 8 weeks and received appropriate medical care. Radiographs showed successful alignment, and the patient gradually resumed her daily activities. The patient had an uneventful recovery, and postoperative radiographs showed good alignment in all planes. CONCLUSIONS The hyperlaxity associated with Down syndrome makes the incidence of HAV more frequent, and TMJ fusion is preferable to correction by osteotomy. The modified Lapidus technique with frontal plane rotational correction could be a good technique to achieve satisfactory correction in patients with severe HAV deformity and flexible valgus flatfoot associated with ligamentous hyperlaxity. TMJ fusion is indicated when severe or recurrent rotational component is observed in X-rays.

Surgical Reconstruction of Nonunion after Iatrogenic Scarf Osteotomy.

We present the case of a young patient, 32 years old, with nonunion in the diaphysis of the first metatarsal after scarf osteotomy for correction of hallux valgus. After removal of the failed osteosynthesis material and preparation of the bone fragments, a calcaneal bone autograft, previously extracted from the patient, was placed in the nonunion area. The new physiological position of the first metatarsal in the three planes was checked intraoperatively, and autograft and fragment fixation was performed using a combination of a low-profile plate with six screws and two interfragmentary screws. The advantage of using an autogenous graft is that it provides corticocancellous bone and great osteogenic capacity with little antigenic capacity. This makes it an excellent option in many situations in foot and ankle surgery. Regarding the fixation method, we used the two most commonly used techniques for osteosynthesis of bone grafts in cases of bone nonunion, combining plates with locking screws and two interfragmentary screws. This provides greater stability of the bone fragments in the three planes and makes it possible to bring forward when the patient starts postsurgical loading.

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

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.

Analysis of gastrocnemius recession and medial column procedures as adjuncts in arthroereisis for the correction of pediatric pes planovalgus: a radiographic retrospective study.

UNLABELLED: The radiographic outcomes of 28 feet in 20 pediatric patients with pes planovalgus treated with subtalar arthroereisis, arthroereisis combined with gastrocnemius recession, or arthroereisis combined with gastrocnemius recession and medial column reconstruction were retrospectively analyzed. Preoperative and postoperative radiographic angles for talar declination, calcaneal inclination, and first metatarsal declination in the lateral view, and the angle formed between the longitudinal axis of the talus and the longitudinal axis of the lesser tarsus in the anteroposterior view were compared. Overall, analyses revealed statistically significant differences in the preoperative and postoperative radiographic angles for the 4 measured angles. Analysis by treatment group revealed statistically significant differences in correction of the angle measured in the anteroposterior view. Arthroereisis with gastrocnemius recession showed the greatest correction of this angle (median 19 degrees, range 11 degrees to 34 degrees) compared with the other treatment groups. There were no statistically significant differences in the degree of correction of the calcaneal inclination or talar declination angles, whereas a statistically significant difference in the correction of first metatarsal declination was observed. The greatest degree of angular change was achieved with medial column reconstruction (median 7 degrees, range 0 degrees to 9 degrees). Gastrocnemius recession displayed a notable effect on the correction of transverse plane deformity when used as an adjunct to arthroereisis. However, medial column reconstruction has a negative impact on the degree of correction in the transverse plane when it is used as an adjunct to arthroereisis and gastrocnemius recession. LEVEL OF CLINICAL EVIDENCE: 4.

Retrospective Analysis of Plantar Fascia by Ultrasound Imaging in Patients with Plantar Fasciitis.

BACKGROUND: We compared diagnostic ultrasound images of the plantar fascia with available patient histories for symptomatic patients previously diagnosed as having plantar fasciitis. Plantar fascia thickness and depth, the prevalence of perifascial hypoechoic lesions, and injury timelines in patients were reviewed. METHODS: Images and histories for 126 symptomatic patients were collected from a patient database. We documented plantar fascia depth and thickness and the visualization of hypoechoic perifascial lesions. After image analysis, the obtained plantar fascia thickness measurements were compared with various patient attributes for possible relationships, including age, weight, and body mass index. In addition, plantar fascia thickness measurements were separated based on injury timeline as well as symptomatic/asymptomatic foot for patients with unilateral conditions to check for significant differences between subgroups. These were, in turn, compared with a control group of 71 individuals with no heel pain or diagnosis of plantar fasciitis. RESULTS: Overall, mean ± SD symptomatic thickness (n = 148) was 6.53 ± 1.56 mm. Mean ± SD symptomatic depth (n = 136) was 13.36 ± 2.14 mm. For the control group, mean ± SD thickness was 3.20 ± 0.66 mm and depth was 10.30 ± 2.00 mm. Comparison of thickness based on injury timeline showed two significant differences: acute injuries (≤3 months) are significantly thicker than chronic injuries (>3 months), and only acute symptomatic thicknesses are significantly different from their asymptomatic thickness counterparts. Age, weight, and body mass index did not show significant correlations to thickness. Analysis of ultrasound images showed that 93% of symptomatic feet had hypoechoic lesions. CONCLUSIONS: Injury timeline and the presence of hypoechoic lesions may play important roles in patient discomfort, diagnosis, and treatment of plantar fasciitis.

Hammertoe surgery and the Trim-it Drill pin.

UNLABELLED: Digital deformities are some of the most frequent complaints of patients seeking a surgical solution after the failure of conservative care. A thorough assessment of the actual level of deformity is important to ensure a lasting surgical correction. This article details the options for correcting hammertoe, clawtoe and mallet toe deformities with Trim it Drill pin and the Spin pin. LEVELS OF EVIDENCE: Level 5.