Successful Fusion Rate Research Articles

Effective use of actifuse shape in spinal fusion: A retrospective chart review

Introduction: This study aimed to assess the safety and clinical performance of Actifuse Shape for spine surgery. Method: A retrospective real-world data study was conducted in two research sites in the U.S. Patient medical records had to show evidence of implantation with Actifuse Shape in 1-2 levels or 2 or more levels cervical (C2 or lower), in either posterolateral thoraco-lumbar or lumbar spine fusion procedures, among other eligibility criteria. All fusion assessments were completed using the Glassman 5 grade fusion scale. Results: Fifty-five (55) medical records were included in the full analysis set, and of these, 42 were eligible, achieving 97.6% bone fusion with a 95% CI (87.4%, 99.9%). Fusion success rates (Grade 4 or 5): 6 mo 72.7% (n=8/11), 12 mo 97.6% (n=41/42) and 24 mo 100% (n=49/49). No device-related adverse events were reported for Actifuse Shape. A “worst-case” imputation post hoc analysis was performed to take into account five patients who did not show evidence of fusion at 6 mo and were lost to follow up and were assumed to continue showing no evidence of fusion throughout the remaining study period. Forty-one out of 47 (87.2%) patients (95% CI: 74.3, 95.2) achieved successful fusion at 12 mo (±60 days) and 49/55 (89.1%) patients (95% CI: 77.8, 95.9) achieved successful fusion at 24 mo (+60 days). Conclusions: Actifuse Shape is safe and is associated with high rate of bony fusion when implanted as the primary bone graft substitute in spinal fusion surgeries.

Evaluation of the Efficacy of Unilateral Biportal Endoscopic Lamina Osteotomy Replantation Assisted by Ultrasonic Bone Scalpel in the Treatment of Lumbar Infectious Spondylitis

To analyze the clinical efficacy of ultrasonic bone scalpel (UBS)-assisted unilateral biportal endoscopic lamina osteotomy replantation (ULOR) for treating lumbar infectious spondylitis (LIS). We conducted a retrospective analysis of patients with LIS who had therapy with UBS-assisted ULOR at our hospital between January 2020 and May 2023. A total of 17 instances matched the inclusion criteria, consisting of 7 females and 10 males. The UBS was utilized during surgery to extract the lamina completely, followed by large bone grafting to fuse the cleaned intervertebral space. The study recorded and analyzed various parameters in the included patients before and after surgery. All 17 patients underwent a successful operation with an average duration of 136.82±21.35minutes, average blood loss of 77.43±10.19ml, and an average follow-up period of 18.55±3.47months. Following the surgical intervention, the patients experienced a substantial improvement in their clinical symptoms, accompanied by a significant drop in white blood cell, erythrocyte sedimentation rate, and C-reactive protein levels (all P<0.001). The postoperative visual analog scale scores and Oswestry Disability Index showed considerable improvement (both P < 0.001). The postoperative Cobb angle and intervertebral space height were significantly corrected (P< 0.001). At the last follow-up, the success rate of lumbar fusion was 100%, and there were no instances of infection recurring. The use of ULOR with assistance from UBS for the treatment of LIS has proven to be beneficial. It provides significant relief from symptoms and corrects lumbar deformity. This surgical procedure is both effective and safe.

Minimally Invasive Surgery for Posterior Atlantoaxial Lateral Mass Joint Fusion (MIS-PALF): A Muscle-Sparing Procedure for Atlantoaxial Instability or Dislocation.

Conventional surgical procedures for atlantoaxial instability or dislocation (AAI/D) have been associated with a high prevalence of postoperative occipitocervical pain and dysfunction, as well as substantial perioperative blood loss. We hypothesized that minimally invasive surgery for posterior atlantoaxial lateral mass joint fusion (MIS-PALF), a procedure that can largely avoid disruption of suboccipital musculature, would be superior to the standard Goel-Harms technique in terms of postoperative pain and perioperative blood loss. This was a prospective cohort study of patients undergoing MIS-PALF for AAI/D at Peking University Third Hospital's Department of Orthopaedics from January 2021 to December 2021 and a historical control group of patients with the same diagnoses who were treated with the Goel-Harms technique. The duration of surgery, perioperative blood loss, postoperative length of hospital stay, postoperative body temperature, pain, supplementary use of narcotics, spinal cord function/improvement (assessed using the Japanese Orthopaedic Association [JOA] scores), reduction of AAI/D (determined based on radiographic parameters), rate of successful fusion, and complication rate were all compared between the 2 groups. No significant differences were noted between the groups (43 MIS-PALF cases, 86 control cases) regarding baseline data, operative time, spinal cord function or improvement, reduction of AAI/D, rate of successful fusion, and complication rate. MIS-PALF was associated with significantly less perioperative blood loss, a shorter postoperative hospital stay (decreased by 30.8%), lower intensity and frequency of postoperative pain (decreased by 10.6% and 61.9%, respectively), less need for supplementary narcotics, and less frequent postoperative fever (decreased by 48.7%). This was the first prospective cohort study of which we are aware on minimally invasive procedures for atlantoaxial fusion. Clinical efficacy (AAI/D reduction, rate of successful atlantoaxial fusion, JOA score improvement), efficiency (operative time), and safety (complications) of MIS-PALF appeared to be noninferior to those of the Goel-Harms technique. MIS-PALF was superior in terms of postoperative occipitocervical pain and length of hospital stay, both of which directly affect overall patient satisfaction and postoperative recovery of quality of life. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

High Lumbar Spinal Fusion Rates Using Cellular Bone Allograft Irrespective of Surgical Approach.

Mounting evidence demonstrates a promising safety and efficacy profile for spinal fusion procedures using cellular bone allograft (CBA). However, limited data exists on fusion outcomes stratified by surgical approach. The current study investigates the effectiveness of CBA in lumbar spinal fusion by surgical approach (ie, anterior, lateral, and posterior approaches). Patients undergoing lumbar spinal fusion with CBA (Trinity Elite) were enrolled into a prospective, multi-center, open-label clinical study (NCT02969616). Fusion status was assessed by an independent review of dynamic radiographs and computed tomography images. Clinical outcome measures included quality of life (QoL; EQ5D), disability (Oswestry Disability Index [ODI]), and pain (visual analog scale [VAS]) for back pain and leg pain). Patient data extending to 24 months were analyzed in a post-hoc analysis. A total of 252 patients underwent interbody fusion (159 women; 93 men). Patients had a mean age of 58.3 years (SD 12.5), height of 168.3 cm (SD 10.2), and weight of 87.3 kg (SD 20.0) with a body mass index of 30.8 kg/m2 (SD 6.5). At 12 months, the overall fusion success rate for bridging bone was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for anterior, lateral, and posterior approaches, respectively. At 24 months, the overall fusion success rate for bridging bone was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for anterior, lateral, and posterior approaches, respectively. The surgical approach did not significantly impact fusion success. A significant (P < 0.0001) improvement in QoL, pain, and disability scores was also observed. Significant differences in the ODI, VAS, and EQ5D were observed between the treatment groups (P < 0.05). CBA represents an attractive alternative to autograft alone, reporting a high rate of successful fusion and clinical outcomes across various surgical approaches. The use of CBA for spinal fusion procedures, regardless of surgical approach, provides high rates of fusion with a favorable safety profile and improved patient outcomes. NCT02969616.

Efficacy of using autologous cells with graft substitutes for spinal fusion surgery: A systematic review and meta-analysis of clinical outcomes and imaging features.

Over the past several decades, there has been a notable increase in the total number of spinal fusion procedures worldwide. Advanced spinal fusion techniques, surgical approaches, and new alternatives in grafting materials and implants, as well as autologous cellular therapies, have been widely employed for treating spinal diseases. While the potential of cellular therapies to yield better clinical results is appealing, supportive data are needed to confirm this claim. This meta-analysis aims to compare the radiographic and clinical outcomes between graft substitutes with autologous cell therapies and graft substitutes alone. PubMed, Scopus, Web of Science, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials were searched for studies comparing graft substitutes with autologous cell therapies and graft substitutes alone up to February 2024. The risk of bias of the included studies was evaluated using the Downs and Black checklist. The following outcomes were extracted for comparison: fusion success, complications/adverse events, Visual Analog Scale (VAS) score, and Oswestry Disability Index (ODI) score. Thirteen studies involving 836 patients were included, with 7 studies considered for the meta-analysis. Results indicated that the use of graft substitutes with autologous cell therapies demonstrated higher fusion success rates at 3, 6, and 12 months, lower VAS score at 6 months, and lower ODI score at 3, 6, and 12 months. The complication rate was similar between graft substitutes with autologous cell therapies and graft substitutes alone. Although the current literature remains limited, this meta-analysis suggests that the incorporation of cellular therapies such as bone marrow and platelet derivatives with graft substitutes is associated with a higher fusion rate and significant improvements in functional status and pain following spinal fusion. Future well-designed randomized clinical trials are needed to definitively assess the clinical effectiveness of cellular therapies in spinal fusion.

Association of Poor Bone Quality with Pseudarthrosis and Poor Clinical Outcomes in Single-Level Instrumented Lumbar Arthrodesis Using Local Autologous Bone Graft.

Although osteoporosis and low bone mineral density is thought to lead to poor fusion outcomes, few studies have adequately addressed the correlation, and they were limited by small sample size at a single institution. We completed a secondary analysis of 182 patients enrolled at 26 spine centers across the United States in the EXO-SPINE FDA-approved clinical trial with 12-month CT-based fusion status determined by two independent, blinded radiologists. Using previously described CT-based techniques, we measured local and global Hounsfield units (HU) and examined the relationship with radiographic and clinical outcomes. CT scans were available for review from 95 patients, with a mean age of 56.2 years and mean global density of 153.0 HU. No relationship was observed between HU and radiographic fusion status or clinical outcomes. Although 12% of patients had lumbar vertebral body HU measurements consistent with osteoporosis, this classification had no relation with fusion or clinical outcomes. Patients with pseudarthrosis had higher Oswestry Disability Index (22.2 vs. 16.6, P = 0.037) and back pain visual analog scale (7.0 vs. 4.9, P = 0.014) scores than patients with at least unilateral fusion at the 12-month follow-up. In this large, multicenter study, lower vertebral body HU was not associated with worse fusion status after single-level instrumented posterolateral lumbar fusion using only local autologous bone graft. However, there was an association between radiographic fusion status and clinical outcomes, validating the importance of determining predictors of successful fusion. Assessment of fusion status with CT scans yielded a much lower fusion success rate with local bone graft than previously reported and may warrant additional investigation.

Impact of surgical risk factors for non-union on lumbar spinal fusion outcomes using cellular bone allograft at 24-months follow-up

BackgroundThe current report investigates fusion rates and patient-reported outcomes following lumbar spinal surgery using cellular bone allograft (CBA) in patients with risk factors for non-union.MethodsA prospective, open label study was conducted in subjects undergoing lumbar spinal fusion with CBA (NCT 02969616) to assess fusion success rates and patient-reported outcomes in subjects with risk factors for non-union. Subjects were categorized into low-risk (≤ 1 risk factors) and high-risk (> 1 risk factors) groups. Radiographic fusion status was evaluated by an independent review of dynamic radiographs and CT scans. Patient-reported outcome measures included quality of life (EQ-5D), Oswestry Disability Index (ODI) and Visual Analog Scales (VAS) for back and leg pain. Adverse event reporting was conducted throughout 24-months of follow-up.ResultsA total of 274 subjects were enrolled: 140 subjects (51.1%) were categorized into the high-risk group (> 1 risk factor) and 134 subjects (48.9%) into the low-risk group (≤ 1 risk factors). The overall mean age at screening was 58.8 years (SD 12.5) with a higher distribution of females (63.1%) than males (36.9%). No statistical difference in fusion rates were observed between the low-risk (90.0%) and high-risk (93.9%) groups (p > 0.05). A statistically significant improvement in patient-reported outcomes (EQ-5D, ODI and VAS) was observed at all time points (p < 0.05) in both low and high-risk groups. The low-risk group showed enhanced improvement at multiple timepoints in EQ-5D, ODI, VAS-Back pain and VAS-Leg pain scores compared to the high-risk group (p < 0.05). The number of AEs were similar among risk groups.ConclusionsThis study demonstrates high fusion rates following lumbar spinal surgery using CBA, regardless of associated risk factors. Patient reported outcomes and fusion rates were not adversely affected by risk factor profiles.Trial registrationNCT 02969616 (21/11/2016).

1074 A Prospective, Post Market, Multi-center, Open Label, Non-randomized Clinical Study of the Efficacy of Using a Cellular Bone Allograft (CBA) in Lumbar Fusion Surgery

INTRODUCTION: Autologous bone grafting contains the osteoconductive, osteoinductive and osteogenic elements essential for bone healing in patients at a high-risk for nonunion. There is a lack of prospective lumbar fusion studies with comprehensive and objective outcome assessments that utilize alternatives to iliac crest bone grafting. METHODS: This analysis includes subjects with complete clinical and radiographic outcomes at 12-months (n = 221), and 24-months (n = 199) follow-up. Fusion was determined by independent review, characterizing motion (=3° and =3mm) from flexion/extension X-rays, AND the presence of bridging bone via CT. RESULTS: The mean age of the study cohort was 58.8 years with 63% being female, and a mean BMI of 30.7. Regarding the subjects reporting of risk-factors to bone healing (e.g., multilevel disease, BMI, nicotine use, diabetes), 86.5% of subjects reported at least a single risk factor, with 49% (n = 99) of subjects reporting multiple risk-factors to bone healing. Fusion success rates were 91.4% (202/221) at 12-months, and 91.9% (183/199) at 24-months. Patient reported outcomes included VAS Back and Leg Pain, ODI, and EQ-5D. Mean ODI significantly improved by 22.1 (p &lt; 0.001) and 22.7 (p &lt; 0.001) points from baseline at 12 and 24-months respectively. Back pain scores decreased significantly from baseline: 57.47 (28.62) to 18.46 (24.86) at 12 months, and 12.02 (21.01) at 24 months. VAS leg pain also significantly decreased from baseline to 12 and 24 months, with an overall decrease in mean score of 27.54 and 32.09 respectively. CONCLUSIONS: These study findings provide additional support for the viability and efficacy of CBAs in spinal fusion. The fusion rates observed in this study are comparable to ICBG fusion rates reported in the literature.

Targeted Delivery of Abaloparatide to Spinal Fusion Site Accelerates Fusion Process in Rats.

Spinal fusions are performed to treat congenital skeletal malformations, spondylosis, degenerative disk diseases, and other pathologies of the vertebrae that can be resolved by reducing motion between neighboring vertebrae. Unfortunately, up to 100,000 fusion procedures fail per year in the United States, suggesting that efforts to develop new approaches to improve spinal fusions are justified. We have explored whether the use of an osteotropic oligopeptide to target an attached bone anabolic agent to the fusion site might be exploited to both accelerate the mineralization process and improve the overall success rate of spinal fusions. The data presented below demonstrate that subcutaneous administration of a modified abaloparatide conjugated to 20 mer of D-glutamic acid not only localizes at the spinal fusion site but also outperforms the standard of care (topically applied BMP2) in both speed of mineralization (p < 0.05) and overall fusion success rate (p < 0.05) in a posterior lateral spinal fusion model in male and female rats, with no accompanying ectopic mineralization. Because the bone-localizing conjugate can be administered ad libitum post-surgery, and since the procedure appears to improve on standard of care, we conclude that administration of a bone-homing anabolic agent for improvement of spinal fusion surgeries warrants further exploration.

Dosing Strategy for Osteobiologics Used in ACDF Surgery: Influence on Fusion Rates and Associated Complications. A Systematic Literature Review.

Systematic review. To assess the available evidence related to dose-dependent effectiveness (i.e., bone fusion) and morbidity of osteobiologics used in anterior cervical discectomy and fusion (ACDF). Studies with more than 9 adult patients with degenerated/herniated cervical discs operated for one-to four-levels ACDF reporting used osteobiologics doses, fusion rates at six months or later, and related comorbidities were included. PubMed, EMBASE, ClinicalTrials, and Cochrane were searched through September 2021. Data extracted in spread sheet and risk of bias assessed using MINORS and Rob-2. Sixteen studies were selected and sub-grouped into BMP and non-BMP osteobiologics. For the 10 BMP studies, doses varied from 0.26 to 2.1mg in 649 patients with fusion rates of 95.3 to 100% at 12months. For other osteobiologics, each of six studies reported one type of osteobiologic in certain dose/concentration/volume in a total of 580 patients with fusion rates of 6.8 to 96.9% at 12months. Risk of bias was low in three of the 13 non-randomized (18.75%) and in all the three randomized studies (100%). Taking into account the inconsistent reporting within available literature, for BMP usage in ACDF, doses lower than 0.7mg per level can achieve equal successful fusion rates as higher doses, and there is no complication-free dose proved yet. It seems that the lower the dose the lower the incidence of serious complications. As for non-BMP osteobiologics the studies are very limited for each osteobiologic and thus conclusions must be drawn individually and with caution.

Safety and efficacy of autologous bone marrow clot as a multifunctional bioscaffold for instrumental posterior lumbar fusion: a 1-year follow-up pilot study.

Bone marrow aspirate (BMA), when combined with graft substitutes, has long been introduced as a promising alternative to iliac crest bone graft in spinal fusion. However, the use of BMA is limited by the absence of a standardized procedure, a structural texture, and the potential for diffusion away from the implant site. Recently, the potential use of a new formulation of BMA, named BMA clot, has been preclinically described. In this report, we present the results of a prospective pilot clinical study aimed at evaluating the safety and efficacy of autologous vertebral BMA (vBMA) clot as a three-dimensional and multifunctional bioscaffold in instrumented posterior lumbar fusion. Ten consecutive patients with an indication of multilevel (≤5) posterior spinal fusion due to lumbar spine degenerative diseases were included in the study and treated with vBMA. Clinical outcomes were assessed using the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and EuroQoL-5L (EQ-5L) preoperatively and at 3 months and 12 months after spinal fusion. Bone fusion quality was evaluated at the 12-month follow-up using the Brantigan classification on radiography (XR) imaging. Bone density was measured on computed tomography (CT) scans at 6 and 12 months of follow-up visits at the intervertebral arches and intervertebral joint areas and expressed in Hounsfield unit (HU). The results indicate a successful posterolateral fusion rate of approximately 100% (considering levels with C, D, and E grades according to the Brantigan classification) at the 12-month follow-up, along with an increase in bone density from 6 to 12 months of follow-up. An improvement in the quality of life and health status following surgery, as assessed by clinical scores (ODI, VAS, and EQ-5L), was also observed as early as 3 months postsurgery. No adverse events related to the vBMA clot were reported. This prospective pilot study demonstrates the effectiveness and safety profile of vBMA clot as an advanced bioscaffold capable of achieving posterior lumbar fusion in the treatment of degenerative spine diseases. This lays the groundwork for a larger randomized clinical study.

Fusion Assessment of Oblique Lumbar Interbody Fusion Using Demineralized Bone Matrix: A 2-Year Prospective Study.

Although several studies have reported successful fusion rates after oblique lumbar interbody fusion (OLIF) using allografts or dimerized bone matrix (DBM) instead of autografts, whether OLIF can achieve satisfactory solid fusion without the use of autografts remains unclear. This study investigated the real fusion rates after OLIF using allografts and DBM, which were evaluated using both dynamic radiographs and computed tomography scans. We enrolled 79 consecutive patients who underwent minimally invasive OLIF followed by percutaneous pedicle screw fixation. All patients were treated with OLIF between L2 and L5 and underwent radiographic and clinical follow-ups at 12, 18, and 24 months after surgery. Radiographic assessment of fusion was performed using the modified BrantigaSteffee-Fraser (mBSF) scale, which was categorized as follows: grades I (radiographic pseudoarthrosis), II (indeterminate fusion), and III (solid radiographic fusion). Other radiologic and clinical outcomes were evaluated using the following parameters: vertebral slippage distance, disc height, subsidence, Oswestry Disability Index (ODI), and visual analogue scale (VAS). Clinical outcomes demonstrated significant improvements in the VAS scores for back pain, leg pain, and ODI after surgery. Subsidence was present in 34 cases (35.4%) at 12 months postoperatively, which increased to 47.9% and reached 50.0% at 1.5 years and 2 years after surgery, respectively. The solid fusion rate after OLIF was 32.3% at 1 year, increased to 58.3% at 1.5 years, and reached 72.9% at 2 years. Radiographic pseudoarthrosis was 24.0% at 1 year, which decreased to 6.3% at 1.5 years and 3.1% at 2 years. OLIF is a safe and effective surgical procedure for the treatment of degenerative lumbar diseases. The mBSF scale, which simultaneously evaluates both dynamic angles and bone bridge formation, offers great reliability for the radiological assessment of fusion. Moreover, OLIF using allografts and DBM, which is performed on one or 2 levels at L2-5, can achieve satisfactory fusion rates within 2 years after surgery.

Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion

BackgroundAutologous bone grafts are the gold standard for spinal fusion; however, harvesting autologous bone can result in donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allografts (CBAs) are a viable alternative that avoids the need for bone harvesting and may increase fusion success alone or when used as an adjunct material. The present study examined the efficacy and safety of CBA when used as an adjunct graft material to lumbar arthrodesis.MethodsA prospective, single-arm, multicenter clinical trial (NCT 02969616) was conducted in adult subjects (> 18 years of age) undergoing lumbar spinal fusion with CBA graft (CBA used as primary (≥ 50% by volume), with augmentation up to 50%). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcomes were assessed with the Oswestry Disability Index (ODI), and Visual Analog Scales (VAS) score for back and leg pain. Adverse events were assessed through the 24-month follow-up period. The presented data represents an analysis of available subjects (n = 86) who completed 24 months of postoperative follow-up at the time the data was locked for analysis.ResultsPostoperative 24-month fusion success was achieved in 95.3% of subjects (n = 82/86) undergoing lumbar spinal surgery. Clinical outcomes showed statistically significant improvements in ODI (46.3% improvement), VAS-Back pain (75.5% improvement), and VAS-Leg pain (85.5% improvement) (p < 0.01) scores at Month 24. No subject characteristics or surgical factors were associated with pseudoarthrosis. A favorable safety profile with a limited number of adverse events was observed.ConclusionsThe use of CBA as an adjunct graft material showed high rates of successful lumbar arthrodesis and significant improvements in pain and disability scores. CBA provides an alternative to autograft with comparable fusion success rates and clinical benefits.Trial registrationNCT 02969616.

Pulsed Electromagnetic Field Stimulation in Lumbar Spine Fusion for Patients With Risk Factors for Pseudarthrosis.

Lumbar spinal fusion surgeries are increasing steadily due to an aging and ever-growing population. Patients undergoing lumbar spinal fusion surgery may present with risk factors that contribute to complications, pseudarthrosis, prolonged pain, and reduced quality of life. Pulsed electromagnetic field (PEMF) stimulation represents an adjunct noninvasive treatment intervention that has been shown to improve successful fusion and patient outcomes following spinal surgery. A prospective, multicenter study investigated PEMF as an adjunct therapy to lumbar spinal fusion procedures in patients at risk for pseudarthrosis. Patients with at least 1 of the following risk factors were enrolled: prior failed fusion, multilevel fusion, nicotine use, osteoporosis, or diabetes. Fusion status was determined by radiographic imaging, and patient-reported outcomes were also evaluated. A total of 142 patients were included in the analysis. Fusion status was assessed at 12 months follow-up where 88.0% (n = 125/142) of patients demonstrated successful fusion. Fusion success for patients with 1, 2+, or 3+ risk factors was 88.5%, 87.5%, and 82.3%, respectively. Significant improvements in patient-reported outcomes using the Short Form 36, EuroQol 5 Dimension (EQ-5D) survey, Oswestry Disability Index, and visual analog scale for back and leg pain were also observed compared with baseline scores (P < 0.001). A favorable safety profile was observed. PEMF treatment showed a positive benefit-risk profile throughout the 6-month required use period. The addition of PEMF as an adjunct treatment in patients undergoing lumbar spinal surgery provided a high rate of successful fusion with significant improvements in pain, function, and quality of life, despite having risk factors for pseudarthrosis. PEMF represents a useful tool for adjunct treatment in patients who have undergone lumbar spinal surgery. Treatment with PEMF may result in improved fusion and patient-reported outcomes, regardless of risk factors. NCT03176303.

Minimally Invasive Surgery vs Open Approach to First Metatarsophalangeal Joint Arthrodesis: A Comparison of Surgical Outcomes

Category: Midfoot/Forefoot; Other Introduction/Purpose: Minimally invasive surgery (MIS) is becoming increasingly popular among foot and ankle orthopaedic surgeons, as it has been shown to have limited complication rates and faster recovery times. Although there is robust data on MIS to treat hallux valgus, few studies have evaluated the role of MIS for 1st metatarsophalangeal (MTP) fusion to treat hallux rigidus - the most common arthritis of the foot. Hallux rigidus affects 2.5% of the U.S. population over age 50. Given this disease prevalence, it is important to characterize outcomes following MTP fusion procedures to optimize surgical approaches. In this retrospective cohort study, we aim to compare (1) patient-reported pain, (2) rate of successful fusion, and (3) rate of complications between groups who underwent open or MIS 1st MTP arthrodesis. Methods: This retrospective cohort study was conducted by evaluating clinical metrics, surgical outcomes, and radiographic data through chart review of 78 patients (25 male, 53 female), who underwent a 1st MTP fusion procedure at a large urban academic medical center from July 2015 through January 2023. 71 patients had a diagnosis of hallux rigidus, with other common diagnoses including hammertoe (24), hallux valgus (24), additional arthritides (11), and metatarsalgia (11). Two patients were excluded from our analysis due to lack of sufficient orthopaedic follow-up preventing evaluation of joint fusion. Pre- and post-operative pain scores were recorded on a 0-10 scale, though some notes documented subjective experience of pain (e.g., “minimal”). Complications were identified using post-operative clinic notes. The following radiographic data were included: hallux valgus angle, intermetatarsal angle, Coughlin classification, presence of arthritis, pre-operative sesamoid position, fusion construct materials, and success of fusion. Results: Of the 80 1st MTP fusion surgeries (two patients received both left and right foot operations), 51 were open and 29 were minimally invasive. There was no significant difference in the change in pre- to post-operative pain between the two groups (p=0.39). MIS patients had a higher successful fusion rate (100.0%) when compared to open surgery patients (94.1%), though this difference was insignificant (p=0.55). There was no significant difference in overall complication rates between MIS and open surgery groups (p=0.79). However, the MIS patients did not have any cases of deep infection or wound dehiscence and all (5/5) of their complications were related to hardware removal after fusion, whereas half of the complications (5/10) for the open surgery patients were related to infection and wounds. Conclusion: This retrospective analysis of 78 patients treated for hallux rigidus with 1st MTP fusion surgery showed no significant difference in rates of successful fusion and complications among patients who received an MIS procedure compared to an open surgery. There was no difference in patient-reported pain improvement between the two groups. Our main limitation is provider specialization, as only one surgeon in this study performed the MIS cases. Further studies should be done to obtain higher-level evidence to elucidate potential benefits of MIS over open surgery for 1st MTP arthrodesis.

Iliac crest bone graft versus cell-based grafts to augment spinal fusion: a systematic review and meta-analysis.

Despite successful fusion rates with iliac crest bone graft (ICBG), donor-site morbidity and increased operating time remain a considerable limitation and drive the search for alternatives. In this systematic review, grafts with additional cellular supplementation were compared with ICBG for spinal arthrodesis. We compared safety, efficacy and long-term outcomes, thus providing the current and relevant evidence for orthopaedic surgeons to make informed choices regarding this rapidly developing field. An electronic literature search was conducted according to the PRISMA guidelines by two independent reviewers for articles published up to 1st March 2023 using PubMed, EMBASE and the Cochrane Central Register of Controlled Trial. Cellular allografts were not included. The following data were extracted: Number of patients, type of graft, fusion assessment method, follow-up duration, fusion rates, clinical outcomes and complications. The methodological quality of evidence (MQOE) was assessed using the Risk of Bias 2 (RoB-2) tool and Risk of Bias In Non-Randomised Studies (ROBINS) tool developed by Cochrane for evaluating bias in randomised and non-randomised studies. Ten studies fulfiled the inclusion criteria, including 465 patients. The mean number of patients per study was 43.8 (std dev. 28.81, range 12-100). Two studies demonstrated cell-based therapy to be significantly more successful in terms of fusion rates compared to ICBG. However, the remaining eight demonstrated equivocal results. No study found that cell-based therapy was inferior. No difference was seen between the two groups in three studies who focused on degenerative cohorts. No difference in functional outcome scores was seen between the groups. A number of different preparation techniques for cell-based grafts were used throughout the studies. Cell-based therapy offers a promising alternative to ICBG in spinal fusion surgery, which could help reduce the associated morbidity to patients. This review found that cell-based therapy is non-inferior to iliac crest bone graft and may offer patients an alternative treatment option with fewer complications and reduced post-operative pain. However, the literature to date is limited by heterogeneity of the cell preparation and grafting process. Future research with a unified approach to the cell preparation process is required to fully delineate the potential advantages of this technology.

Blockchain based trusted execution environment architecture analysis for multi - source data fusion scenario

Multi-source data fusion techniques are widely applied in dynamic target detection scenarios, such as target situational awareness, radar signal resolution, and feature fusion labeling. Currently, techniques including clustering, neural networks, Bayesian analysis, and machine learning have been applied to improve the success rate of multi-source data fusion in terms of interference data noise reduction. The research on data tampering prevention of multiple data sources is mainly based on the data distributed authentication technology. The research on performing data fusion process in a trusted execution environment is mainly based on cryptography and codec technology. This paper focuses on the technical application architecture that can effectively improve the comprehensive efficiency of multi-source data fusion processing under the constraints of business scenarios. Accordingly, this paper proposes a trusted execution environment architecture based on blockchain technology for multi-source data fusion scenarios. It integrates the strategy of trusted data source data verification in blockchain smart contracts into the typical multi-source data fusion application architecture. After comparison tests in a simulation environment, the trusted execution environment architecture based on blockchain technology has shown considerable improvements in fusion success rate with limited performance cost.

Induced membrane technique combined with a retrograde intramedullary nail for the treatment of infected bone defects of the ankle

In this study, we treated infected ankle bone defects with the induced membrane two-stage technique. The ankle was fused with a retrograde intramedullary nail in the second stage, and the aim of this study was to observe the clinical effect. We retrospectively enrolled patients with infected bone defects of the ankle admitted to our hospital between July 2016 and July 2018. In the first stage, the ankle was temporarily stabilized with a locking plate, and antibiotic bone cement was used to fill the defects after debridement. In the second stage, the plate and cement were removed, the ankle was stabilized with a retrograde nail, and tibiotalar-calcaneal fusion was performed. Then, autologous bone was used to rebuild the defects. The infection control rate, fusion success rate and complications were observed. Fifteen patients were enrolled in the study with an average follow-up of 30 months. Among them, there were 11 males and 4 females. The average bone defect length after debridement was 5.3 cm (2.1–8.7 cm). Finally, 13 patients (86.6%) achieved bone union without recurrence of infection, and 2 patients experienced recurrence after bone grafting. The average ankle-hindfoot function score (AOFAS) increased from 29.75 ± 4.37 to 81.06 ± 4.72 at the last follow-up. The induced membrane technique combined with a retrograde intramedullary nail for the treatment of infected bone defects of the ankle after thorough debridement is an effective treatment method.

Acceptable Fusion Rate of Single-Level OLIF Using Pure Allograft Combined with Posterior Instrumentation through the Wiltse Approach: A 2-Year Follow-Up Study.

Autogenic bone grafts have shown successful fusion rates in the treatment of degenerative lumbar disorders, but taking too many autogenic bones may result in donor site ischemia or infection. This study aimed to evaluate the outcomes of single-level oblique lumbar interbody fusion (OLIF) using pure allograft combined with posterior pedicle screw instrumentation through the Wiltse approach. A retrospective case analysis was performed on a series of consecutive patients who received a single-level OLIF procedure combined with posterior pedicle screw instrumentation through the Wiltse approach between July 1, 2017, and December 31, 2019, in which pure allogenic bone graft was used and filled in the large window of the cage. The patients were followed up as scheduled at 1 day and 3, 6, 12, 24months after operation. Clinical outcome was assessed by multiple questionnaires, including Oswestry disability index (ODI), Japanese Orthopaedic Association (JOA) score rating system, short form-36 health survey (SF-36), and visual analog scale (VAS) for low back pain. Radiographic outcome was evaluated by measuring the parameters such as disc height, lumbar lordosis, and segmental angle on the standard standing lateral radiographs, and the space angle of the fusion level on the dynamic views of the lateral radiographs. Subsidence of the cage and intervertebral fusion status were evaluated on both the radiographic and CT scan images. A total of 34 patients were finally included in this study. At 2-year follow-up, the VAS for low back pain, ODI, JOA, and SF-36 scores all had significant improvement (p < 0.001). Substantial increase of anterior and posterior disc heights was observed (p < 0.001). Both lumbar lordosis and segmental angle became larger (p < 0.05). No visible change of the space angle of the fusion level was found on the dynamic views. The 1-year fusion rate of 73.5% on CT scans proceeded to 82.4% at 2-year follow-up. The fusion rate was as high as 91.2% according to Bridwell interbody fusion grading system on radiographic images. The clinical outcomes in patients with incomplete fusion were just as good as those with complete fusion. The six patients with cage subsidence had higher ODI (p < 0.001) and lower JOA (p < 0.001) and SF-36 PCS (p=0.011) scores than those without cage subsidence. The use of pure allograft in single-level OLIF resulted in an acceptable fusion rate and satisfactory clinical effect at 2-year follow-up. Supplementation of posterior pedicle screw through the minimally invasive Wiltse approach ensured the favorable outcomes both clinically and radiographically.

Transportal Tibiotalocalcaneal Nail Ankle Arthrodesis: A Systematic Review of Initial Series.

There is currently a scarcity of information and consensus for transportal (arthroscopic or fluoroscopic) joint preparation during tibiotalocalcaneal (TTC) fusion, and therefore this review aims to summarize the available techniques and to evaluate the outcomes after this procedure. A systematic electronic search of MEDLINE, EMBASE, and Web of Science was performed for all English-language studies published from their inception to April 4, 2022. All articles addressing arthroscopy in TTC nailing were eligible for inclusion. The PRISMA Checklist guided the reporting and data abstraction. Descriptive statistics are presented. A total of 5 studies with 65 patients were included for analysis. All studies used arthroscopic portals for tibiotalar and subtalar joint preparation (in 4 studies) prior to TTC nailing, with 4 studies using an arthroscope and 1 study using fluoroscopy. The overall major complication rate was 13.8%; however, there was only 1 instance of deep wound infection (1.5%) and 4 instances of surgical site infections (6.2%). Full fusion was achieved in 86% of patients with an average time to fusion of 12.9 weeks. The mean American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot score preoperatively was 34.0 and postoperatively was 70.5. Although limited by the number of studies, transportal joint preparation during TTC nail ankle fusion is associated with good rates of complications and successful fusion. Level III, systematic review of Level III-IV studies.