Bio-integrative vs Metallic Screws in Calcaneus Osteotomies: A Non-Inferiority Randomized Clinical Trial

Category: Hindfoot; Other Introduction/Purpose: The use of bio-integrative implants in orthopedic surgery is growing exponentially. Advantages, such as reduced implant-related artifact production, lower removal rates, and superior bone interaction, have been advocated. However, while many biomechanical and histological reports could sustain its structural and biological properties, only some clinical studies were produced that could support its use. Therefore, this trial intended to determine the bio-integrative screws' capacity to reach the same clinical and radiographical outcomes of current metallic screws in calcaneus osteotomies. Our main hypothesis was that metallic and bio-integrative screws would not present differences when comparing bone healing and complications. Methods: This was a single center, in parallel groups, randomized non-inferiority clinical trial (NCT05018130) that included patients undergoing a calcaneal sliding osteotomy from November 2021 to January 2023. Patients were randomized in a 1 to 1 ratio by software in the metallic or bio-integrative groups, and allocation occurred after anesthesia was carried out. Surgeries were performed by a single surgeon respecting the same technique, using two canulated 4mm screws, either titanium or fiber, according to the treatment group. The primary outcome was determined by bone using weight-bearing computed tomography (WBCT) in the 6th postoperative week. At least 50% of bone trabeculae crossing the osteotomy site needed to be observed to be considered positive. Secondary outcomes included minor and major complications and bone healing, assessed in the 2nd, 4th, 6th, 12th, 24th, and 48th weeks of follow-up. Two assessors performed readings. Between-group differences were measured with ANOVA and chi-square tests. Results: After twenty-nine patients were assessed initially, 22 subjects were found eligible and included in the study. Groups were similar demographically (ps>0.37), with ten patients allocated to the bio-integrative and 12 to the metallic group. The mean follow- up was 31.64 weeks (min 6; max 48) with no losses through the endpoints. Considering WBCT bone healing at six weeks, the bio (80%) and the metallic (75%) groups had similar rates (p=0.58). At 12 weeks, bone healing was slightly higher in the bio-integrative group (100% vs. 92%; p=0.004). No major complications were observed. Minor complications were similar between groups (10% in bio; 16% in metallic; p=0.56) and composed of superficial infections (one bio, one metallic) and delayed wound healing (one metallic), all resolved by six weeks. Conclusion: Bio-integrative screws presented similar results to metallic screws when used in calcaneus osteotomies, considering bone healing and complications. No differences were found in a medium to long-term follow-up, and no major complications were reported. This non-inferiority clinical trial could contribute to the body of literature supporting the use of bio-integrative screws in clinical practice. Larger and longer trials are necessary to determine the superiority of any implant and its impact on orthopedic surgery

Outcomes of the Bone-Block Lapidus Arthrodesis (LapiCotton) in the Treatment of the Collapsed Foot

Category: Midfoot/Forefoot; Bunion Introduction/Purpose: Progressive collapsing foot deformity (PCFD), Hallux Valgus (HV), and Midfoot Arthritis (MA) are diseases that benefit from the Lapidus procedure due to its capability to provide a stable medial column while correcting the underlying deformity. However, the technique does not go without complications. First metatarsal shortening/dorsiflexion are not uncommon, which could be exacerbated by local anatomy/revision surgery settings. Restoring length and sagittal plane position (plantarflexion) of the first ray when treating these pathologies is paramount. Performing a primary distraction and plantarflexion fusion with an allograft wedge (LapiCotton) has been advocated in the literature, potentially allowing improved deformity correction, but with the risk of increased non-union rate. The objective of this study was to report medium-term follow-up results of the LapiCotton in patients with collapsed feet. Methods: This IRB-approved comparative prospective study assessed patients diagnosed with PCFD, HV, and MA undergoing a Lapidus bone-block fusion (LapiCotton) between August 2020 and November 2022. All patients were operated on by a single fellowship-trained foot and ankle surgeon after clinical evaluation and a weight-bearing computed tomography (WBCT). After adequate joint preparation and trials, a Lapidus pre-shaped wedge allograft was placed and fixed using available implants. Adjunctive procedures were carried out as needed. Patients were kept non-weight bearing for six weeks and followed clinically, performing a WBCT at three months and subsequent follow-up. Non-Union and complications were documented. Bone healing was determined by at least 50% of bone trabeculae crossing both graft interfaces at the WBCT. Forefoot arch angle (FFA), Meary’s angle, talonavicular coverage angle (TNCA), middle facet subluxation (MFS), and foot and ankle offset (FAO) were also obtained. Two fellowship-trained readers performed all assessments. P-values >0.05 were considered significant. Results: Fifty-eight patients (60 feet) were included, mean age 53.87 (range:18-77)/BMI 31.70 (SD:7.96). Twenty-four PCFD, 19 HV, and 17 MA had an average 15.47 months (4-31) follow-up. Cuneiform-Post implants were used in 62%, plates/screws in 25%, and Lapidus nails in 13%. Median allograft size was 9mm (mode:8mm,5-19mm). Minor complications were observed in 3% (two superficial dehiscences) and major in 7% (three deep infections [5%], and one EHL contracture [2%]). Healing at the 3-month WBCT occurred in 94.8% and only in 66% at the most-recent WBCT (mean:11.08 months; 6-20). The clinical non-union rate demanding reoperation was eight clinical non-unions 13%. Mean FFA (pre:6.89,SD:6.63; postop:14.21,SD:5.48; p< 0.001), Meary (pre:15.17,SD:8.12; postop:6.31,SD:5.61; p< 0.001), TNCA (pre:26.75,SD:11.77; postop:11.59,SD:7.91; p< 0.001), MFS (pre:36.3,SD:26; postop:23.49,SD:17.35; p< 0.001), and FAO (pre:6.71,SD:5.81; postop:2.2,SD:4.33; p< 0.001) improved after the interventions. Conclusion: Although the Lapidus bone-block arthrodesis (LapiCotton) restored many of the markers associated with foot collapse and alignment, non-union rated was noted in 13% what is on the top range of non-union rates reported in the literature for Lapidus arthrodesis. The use of allograft wedges in the fusion site probably explains our findings. The fact that the sample was heterogeneous and composed of considerably severe deformities should also be considered. Also, important to highlight that WBCT findings of fusion site healing was initially 94% at 3-months and only 66% at most recent follow-up). Additional studies and longer-term follow up are needed