Effectiveness of synthetic versus autologous bone grafts in foot and ankle surgery: a systematic review and meta-analysis.

BACKGROUND: All orthopaedic procedures, comprising foot and ankle surgeries, seemed to show a positive trend, recently. Bone grafts are commonly employed to fix bone abnormalities resulting from trauma, disease, or other medical conditions. This study specifically focuses on reviewing the safety and efficacy of various bone substitutes used exclusively in foot and ankle surgeries, comparing them to autologous bone grafts. METHODS: The systematic search involved scanning electronic databases including PubMed, Scopus, Cochrane online library, and Web of Science, employing terms like 'Bone substitute,' 'synthetic bone graft,' 'Autograft,' and 'Ankle joint.' Inclusion criteria encompassed RCTs, case-control studies, and prospective/retrospective cohorts exploring different bone substitutes in foot and ankle surgeries. Meta-analysis was performed using R software, integrating odds ratios and 95% confidence intervals (CI). Cochrane's Q test assessed heterogeneity. RESULTS: This systematic review analyzed 8 articles involving a total of 894 patients. Out of these, 497 patients received synthetic bone grafts, while 397 patients received autologous bone grafts. Arthrodesis surgery was performed in five studies, and three studies used open reduction techniques. Among the synthetic bone grafts, three studies utilized a combination of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) and beta-tricalcium phosphate (ß-TCP) collagen, while four studies used hydroxyapatite compounds. One study did not provide details in this regard. The meta-analysis revealed similar findings in the occurrence of complications, as well as in both radiological and clinical evaluations, when contrasting autografts with synthetic bone grafts. CONCLUSION: Synthetic bone grafts show promise in achieving comparable outcomes in radiological, clinical, and quality-of-life aspects with fewer complications. However, additional research is necessary to identify the best scenarios for their use and to thoroughly confirm their effectiveness. LEVELS OF EVIDENCE: Level II.

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

BACKGROUND: The 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. METHODS: A prospective, open label study was conducted in subjects undergoing lumbar spinal fusion with CBA (NCT02969616) 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. RESULTS: A 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. CONCLUSIONS: This 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 REGISTRATION: NCT02969616 (21/11/2016).

Maxillary sinus opacification after surgery in asymptomatic patients: Transient swelling of the sinus mucosa or graft dispersion into the maxillary sinus. A radiographic report of three cases after a follow-up period of at least 5 years.

Maxillary sinus grafting is a predictable regenerative technique to facilitate maxillary posterior implant placement when there is insufficient vertical bone height inferior to the maxillary sinuses to allow placement of implants of adequate dimensions. It enables an increase in vertical bone height, which makes implant placement easier. Maxillary sinus mucosal membrane perforation is one of the most common intraoperative complications during maxillary sinus grafting and may result in extrusion of graft material into the sinus. When this occurs, the mucociliary function of the maxillary sinus may expel the extruded graft material through its natural ostium, though graft particles may remain in the sinus or possibly occlude the natural ostium. After grafting, transient maxillary sinus mucosal oedema may occur. A postoperative CBCT scan may reveal varying degrees of sinus opacification, namely partial, subtotal or total. Although it is always possible to identify graft material, which may enter the sinus as a result of membrane perforation that might not even be visible to the implantologist during the surgical procedure, it is challenging to assess whether sinus opacification is due to mucosal thickening or mucus accumulation. The aim of the present case series was to offer a pragmatic approach to managing asymptomatic patients whose CBCT scans demonstrated partial, subtotal or total maxillary sinus opacification with bone graft particles that seemed to have been extruded into the sinus.

Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue-Based Products.

This Viewpoint discusses the death of a patient caused by unregulated biological products and efforts to encourage federal government oversight of such products.

Outcomes and complications of surgical treatment modalities for simple bone cysts of the humerus in children and adolescents.

PURPOSE: The aim of this study was to evaluate and compare different surgical treatment modalities for simple bone cysts (SBC) of the humerus regarding their effectiveness and recurrence rate. METHODS: In this retrospective study, patients who received surgical treatment for previously untreated primary SBCs of the humerus were analyzed. Demographic data, cyst-specific as well as treatment-specific parameters, complications, treatment failures, and recurrence rates were collected and correlated with different treatment modalities. Observed procedures were categorized as open procedure (n=20) or osteosynthesis alone (n=3). For the open procedure group, four subgroups could be defined. RESULTS: Twenty-three patients were included. The mean age at diagnosis was 11.6 ± 2.5 years, and the mean postoperative follow-up was 3.9 ± 2.6 years (range 1.0-10.3). After surgical intervention, a total of five (21.7%) patients showed at least one recurrence. Fracture occurred in three (13.0%) cases. The incidence of treatment failure was significantly higher in the curettage, allograft, adjuvants group, with five (83.3%) of six cases showing recurrence, than in the other subgroups (≤ 25.0%) including the osteosynthesis alone group (p=.024). For the open procedure group, the failure-free survival rates were 80.0% after two years and 50.4% after five years. For the three cases treated by osteosynthesis alone, no failures were observed. CONCLUSION: Open procedures showed similar failure rates except for the subgroup using curettage, allograft, and adjuvants which showed significantly higher treatment failure. Promising results were observed in the group which received solely osteosynthesis without cyst excision or filling, as no treatment failure was observed here.

Subcutaneous preservation versus cryopreservation of autologous bone grafts for cranioplasty: A systematic review and meta-analysis.

BACKGROUND: Cranioplasty corrects cranial bone defects using various bone substitutes or autologous bone flaps created during a previous craniectomy surgery. These autologous bone flaps can be preserved through subcutaneous preservation (SP) or cryopreservation (CP). AIM: We aim to compare outcomes and complications for both SP and CP techniques to enhance the current evidence about autologous bone flap preservation. METHODS: Five electronic databases were searched to collect all relevant studies. Records were screened for eligibility. Data were extracted from the included studies independently. We categorized surgical site infection (SSI) as either due to Traumatic brain injury (TBI) or not to reveal potential variations in SSI incidence. The double-arm meta-analysis utilized risk ratios (RR) and mean differences (MD) with corresponding confidence intervals (CI) to pool categorical and continuous outcomes, respectively. Proportions with their respective 95% CIs were pooled for single-arm meta-analyses to determine outcomes related to SP technique. RESULTS: Seventeen studies involving 1169 patients were analyzed. No significant difference in SSI rates was observed between SP and CP methods in patients with or without TBI. SP was linked to shorter hospital stays in two studies (194 patients). Single-arm analysis showed a 17% revision surgery rate across five studies (375 patients) and infection rates in 17 studies for SP. New bone formation occurred in 13.2% of patients, with 19.9% showing resorption. CONCLUSION: SP and CP methods showed similar SSI rates post-craniectomy in TBI and non-TBI patients. SP was associated with reduced hospitalization time, low infection rates, and a moderate need for revision surgery.

Perioperative risk factors for major complications after bone replacement in decompressive craniectomy.

INTRODUCTION: Bone flap replacement after a decompressive craniectomy is a low complexity procedure, but with complications that can negatively impact the patient's outcome. A better knowledge of the risk factors for these complications could reduce their incidence. PATIENTS AND METHODS: A retrospective review of a series of 50 patients who underwent bone replacement after decompressive craniectomy at a tertiary center over a 10-year period was performed. Those clinical variables related to complications after replacement were recorded and their risk factors were analyzed. RESULTS: A total of 18 patients (36%) presented complications after bone flap replacement, of which 10 (55.5%) required a new surgery for their treatment. Most of the replacements (95%) were performed in the first 90 days after the craniectomy, with a tendency to present more complications compared to the subsequent period (37.8% vs 20%, p > 0.05). The most frequent complication was subdural hygroma, which appeared later than infection, the second most frequent complication. The need for ventricular drainage or tracheostomy and the mean time on mechanical ventilation, ICU admission, or waiting until bone replacement were greater in patients who presented post-replacement complications. Previous infections outside the nervous system or the surgical wound was the only risk factor for post-bone flap replacement complications (p = 0.031). CONCLUSIONS: Postoperative complications were recorded in more than a third of the patients who underwent cranial bone flap replacement, and at least half of them required a new surgery. A specific protocol aimed at controlling previous infections could reduce the risk of complications and help establish the optimal time for cranial bone flap replacement.

Similar complications, implant survival, and function following modular prosthesis and allograft-prosthesis composite reconstructions of the proximal femur for primary bone tumors: a systematic review and meta-analysis.

PURPOSE: There is a lack of consensus regarding the best type of reconstruction of the proximal femur following bone tumor resection. The objective of this study was to analyze the complication risks, implant survival, and functional outcomes following modular prosthesis (MP) and allograft-prosthesis composite (APC) reconstruction of the proximal femur after primary bone tumor resections. METHODS: We performed a search in the PubMed and Scopus libraries, obtaining 1 843 studies. We included studies reporting functional outcomes, complications, and implant survival of proximal femur reconstruction with MP or APC following primary bone tumor resection with a 2-year minimum follow-up. We excluded studies analyzing metastatic patients or studies with pooled data in which it was impossible to separate the data of patients with primary bone tumors from those with bone metastases. RESULTS: We analyzed 18 studies (483 patients) reporting on 234 (48%) patients with MP reconstruction and 249 (52%) patients with APC reconstruction. The risk of complications was similar in patients with MP reconstruction (29%; 95% CI [0.11; 0.47]) and APC reconstruction (36%; 95% CI [0.24; 0.47]) (p = 0.48). Implant survival following MP reconstruction ranged from 81 to 86% at 5 years, 75 to 86% at 10 years, and 82% at 15 years. Implant survival following APC reconstruction ranged from 86 to 100% at 5 years and 86% at 10 years, and 86% at 15 years. Functional outcomes following MP reconstruction and APC reconstruction ranged from 24.0 to 28.3 and from 21.9 to 27.8, respectively. CONCLUSION: Patients with primary bone tumor of the proximal femur who underwent MP or APC reconstruction seem to have similar complication risks, implant survival, and functional outcomes.

Morbidity Associated With Distal Tibial Autograft Harvest.

Distal tibial autograft harvesting has been studied in the past, but morbidity at the level of the donor site is unclear. The purpose of this retrospective review is to assess morbidity in distal tibial autograft harvesting associated with foot and ankle arthrodesis procedures. A retrospective analysis was performed utilizing patients treated in the last 13 years at a large, multicenter, academic, tertiary referral, research institution. Included patients were between the ages of 18 and 80 years old. One-hundred and seven patients (39 male; 68 female) underwent ipsilateral distal tibial bone graft (n = 110) harvesting to augment the index procedure. Patients were followed for an average of 11.2 months after surgery (Range: 1-73 months). The incidence rate of distal tibial stress fractures was 4.5%, with an overall postoperative complication rate of 8.2%. Overall, low complication rates associated with distal tibial autograft harvesting were found, supporting the use of the distal tibia as an appropriate site for autograft harvesting in foot and ankle surgery.

The polymicrobial infection affects the infection recurrence rate (not failure) in treating femoral and tibial bone defects with the Masquelet technique-a comparative retrospective analysis of 54 patients with mono- and polymicrobial infections.

INTRODUCTION: This study evaluated whether polymicrobial infection affects reoperation rates due to infection recurrence and treatment failure with the Masquelet technique in infected posttraumatic segmental bone defects of the femur and tibia. METHODS:  We retrospectively analyzed patients treated between 2012 and 2021 in two trauma referral centers. We evaluated demographic data, injury, treatment, infection recurrence, failures, and bone healing rates according to whether the infection was mono- or polymicrobial. After uni-bivariate analysis between patients with polymicrobial and monomicrobial infection, we identified the variables associated with infection recurrence and failure through multivariate analysis. RESULTS:  We analyzed 54 patients, 30 (55.55%) with tibial and 24 (44.44%) femoral segmental bone defects, with a mean follow-up of 41.7 ± 15.0 months. Forty-four (81.48%) presented monomicrobial, and 10 (18.51%) polymicrobial infections. Comparatively, the need for soft tissue reconstruction and the infection recurrence rate was significantly higher in patients with polymicrobial infections. There was no significant difference in the failure rate (20 vs. 6.81% p = 0.23). Multivariable logistic regression analysis identified the polymicrobial infection as the only independent variable associated with infection recurrence (Odds Ratio = 11.07; p = 0.0017). CONCLUSION:  Our analysis suggests that polymicrobial infection is associated with a higher risk of infection recurrence in treating the femur and tibia segmental bone defects with the Masquelet technique. This information can help surgeons to inform patients about this and give them a realistic expectation of the outcome and the possibility of reoperation.

What Is the Likelihood of Union and Frequency of Complications After Parallel Plating and Supplemental Bone Grafting for Resistant Distal Femoral Nonunions?

BACKGROUND: Management of resistant distal femur nonunions is challenging because patients not only have disability from an unhealed fracture, but also often have a shortened femur, stiff knee, deformities, and bone defects to address during revision surgery. Dual plating of the distal femur in such a setting can maintain stability that allows the nonunion to heal while also addressing bone defects and correcting deformities simultaneously. Dual-plating techniques that have been described lack standardization with regard to the size and type of medial-side implants and configuration of the dual-plate construct. QUESTIONS/PURPOSES: (1) What proportion of patients achieve radiologic evidence of union after parallel plating of resistant distal femoral nonunions? (2) What improvements in function are achieved with this approach, as assessed by improvements in femoral length discrepancy, knee flexion, and patient-reported outcome scores? (3) What complications are associated with the technique? METHODS: Between 2017 and 2020, the senior author of this study treated 38 patients with resistant distal femoral nonunions, defined here as nonunions that persisted for more than 12 months since the injury despite a minimum of two previous internal fixation procedures. During the study period, our preferred technique for treating aseptic, resistant distal femoral nonunions was to use dual plates in a parallel configuration augmented with autografts. Of 38 patients, three patients with active signs of infection who underwent resection and reconstruction using bone transport techniques and two patients older than 65 years with deficient distal femur bone stock who underwent endoprosthetic reconstruction were excluded. Of the 33 included patients, 67% (22 of 33) were male. The median age was 40 years (range 20 to 67 years). Nonunion was articular and metaphyseal in 13 patients and metaphyseal only in 20 patients. Our surgical approach was to remove existing implants, perform intraoperative culturing to rule out infection, debride the nonunion, correct the deformity, perform intra-articular and extra-articular lysis of adhesions with quadriceps release, and apply fixation using medial and lateral fixed-angle anatomic locked implants positioned in a parallel configuration. Every attempt to improve length was undertaken, and the defects were filled with autografts. A total of 97% of patients were followed until union occurred (one of 33 was lost to follow-up before union was documented), and 79% (26 of 33) were assessed for functional outcomes at a minimum of 2 years (median 38 months [range 25 to 60 months]) after excluding patients lost to follow-up and those in whom union did not occur after parallel plating. Union was defined as evidence of central trabecular bridging on AP radiographs and posterior cortical bridging on lateral radiographs. These radiologic criteria were defined to overcome difficulties in assessing radiologic healing in patients with lateral and medial plates. With parallel plating, bridging trabecular bone along the posterior cortex on lateral radiographs and the central region on AP radiographs is visualized and can be appreciated and interpreted as evidence of healing in two orthogonal planes. Preoperative and follow-up clinical assessment of knee ROM, the extent of femoral length correction based on calibrated femoral radiographs before and after surgery, and the evaluation of improvement in lower limb function based on the preoperative and follow-up differences in responses to the lower extremity functional scale (LEFS) were studied (the LEFS is scored from 0 to 80, with higher scores representing better function). Complications and secondary surgical procedures to address them were abstracted from a longitudinally maintained trauma database. RESULTS: Sixty-seven percent (22 of 33) of nonunions showed radiologic healing by 24 weeks, and another 24% (eight of 33) healed by 36 weeks. Six percent (two of 33) did not unite, and one patient was lost to follow-up before union was documented. In the 79% (26 of 33) of patients available for final functional outcome assessment, the median femoral shortening had improved from 2.4 cm (range 0 to 4 cm) to 1.1 cm (range 0 to 2.3 cm; p < 0.001), and the median knee ROM had improved from 70° (range 20° to 110°) to 100° (range 50° to 130°; p = 0.002) after surgery. The median LEFS score improved to 63 (range 41 to 78) compared with 22 (range 15 to 33; p < 0.001) before surgery. Serious complications, including major thromboembolic events, iliac graft site infection, knee stiffness (flexion < 60°), and medial plate impingement necessitating removal, were seen in 30% (10 of 33) of patients. Secondary surgical interventions were performed in 24% (eight of 33) of patients to address procedure-related complications. CONCLUSION: Based on our findings, a high likelihood of union and improvements in knee and lower limb function can be expected with parallel plating of resistant distal femur nonunions using anatomic locked plates. However, the increased frequency of complications observed in our study suggests the need for improvements in dual-plating techniques and to explore possible alternative fixation methods through larger multicenter comparative studies. LEVEL OF EVIDENCE: Level IV, therapeutic study.

Vancomycin Flushing Syndrome After the Use of Vancomycin-Impregnated Bone Graft During Spine Surgery: A Case Report.

CASE: Intrawound vancomycin in spine surgery is a common clinical practice. We report a case of a 14-year-old adolescent girl undergoing surgery for scoliosis correction who developed features of vancomycin flushing syndrome after the use of vancomycin-impregnated bone graft. After resuscitation, she was extubated and had an uneventful postoperative recovery. At 1-year follow-up, she is back to her routine without any sequelae of the intraoperative event. CONCLUSION: The use of intrawound vancomycin can result in life-threatening reactions. With the increase in its use, the anesthetist and the surgeon must be aware of such complications.

The effect of anterior superior iliac spine preservation on donor site morbidity and function after harvesting a vascularized iliac bone flap.

BACKGROUND: The purpose of this study was to investigate the effect of anterior superior iliac spine (ASIS) preservation on donor site morbidity and function after harvesting a vascularized iliac bone flap (VIBF). METHODS: Patients who underwent jaws reconstruction with VIBF were divided into a maintaining the anterior superior iliac spine (MASIS) group and a not maintaining the anterior superior iliac spine (NMASIS) group. Pain, tenderness, sensory deficit, gait disturbance, and function of the donor site were evaluated before and after the operation. RESULTS: Thirty-three patients were included in this study, of which 18 were in the MASIS group. The incidence of sensory deficit in the MASIS group was significantly lower than that in the NMASIS group (50.0% vs. 86.7%, p = 0.010). Pain, tenderness, gait disturbance, and function did not differ statistically between the two groups. CONCLUSION: Except for sensory deficit, ASIS preservation has minimal impact on donor site morbidity and function.

Reconstructing a Patellar Tendon Rupture Neglected for 14 Years When Anatomic Restoration Is Not Possible: A Case Report.

CASE: This case highlights the utility and outcomes of an Achilles tendon bone-block allograft in reconstructing the patellar tendon of a 44-year-old man in the setting of a high-riding, irreducible patella after a chronic patellar tendon rupture of 14 years. CONCLUSION: In cases of a neglected patellar tendon rupture with an irreducible high-riding patella, an Achilles tendon bone-block allograft can provide the length and tissue necessary to reconstruct the extensor mechanism. Although reconstruction may not be anatomic, patients can still experience great subjective and objective functional improvement with restoration of the extensor mechanism even after delayed reconstruction.

Complications associated with vertical bone augmentation techniques in implant dentistry: A systematic review of clinical studies published in the last ten years.

Vertical bone augmentation procedures are increasingly necessary in daily practice. However, it has been reported that vertical ridge augmentation is one of the least predictable techniques in terms of complications. The aim of this systematic review was to evaluate and compare complications in relation to the different procedures used for vertical bone augmentation prior to implant placement. This review was conducted according to PRISMA guidelines. An electronic search was carried out in four databases: The National Library of Medicine (MEDLINE/PubMed); Web of Science; SCOPUS; and Cochrane Central Register of Controlled Trials (CENTRAL). The Newcastle-Ottawa Quality Assessment Scale, the Cochrane Collaboration tool for assessing risk of bias, and The Joanna Briggs Institute Critical Appraisal tool were used to assess the quality of evidence in the studies reviewed. Twenty-five studies with a total of 749 vertically augmented sites were included in the review. Complication rates varied among the different procedures: 51.02% for distraction osteogenesis, 38.01% for bone blocks, and 16.80% for guided bone regeneration. Vertical bone augmentation procedures prior to implant placement are associated with frequent surgical complications and should be approached with caution due to their possible impact on clinical treatment success.

Are Vascularized Fibula Autografts a Long-lasting Reconstruction After Intercalary Resection of the Humerus for Primary Bone Tumors?

BACKGROUND: A vascularized fibula graft (VFG) is the vascular autograft most frequently used to restore large segmental long bone defects, particularly in the upper limb. Because the use of a vascularized fibula involves an operation in an uninvolved extremity with potential morbidity, it is important to document that this type of reconstruction is successful in restoring function to the humerus. However, the long-term results of VFG after intercalary resection of the humeral diaphysis for bone tumors are still unknown. QUESTIONS/PURPOSES: (1) What was the complication rate of reconstruction? (2) What was the functional result after surgical treatment, as assessed by the Musculoskeletal Tumor Society (MSTS) score, the American Shoulder and Elbow Society (ASES) score, and Constant score? (3) What was the survivorship of these grafts free from revision and graft removal at 5, 10, and 15 years? METHODS: Between 1987 and 2021, 127 patients were treated at our institution with en bloc resection for a primary malignant or an aggressive benign bone tumor of the humerus; we excluded patients treated with extra-articular resection or amputation. Of those, 14% (18 of 127) were treated with intercalary resection of the humeral diaphysis for primary bone tumors and reconstruction with VFG, with or without a bulk allograft, and were analyzed in this retrospective study. Generally, our indications for reconstruction with VFG are intercalary resection of the humerus for primary malignant or aggressive benign bone tumors in patients with long life expectancy and high functional demands, in whom adequate bone stock of the proximal and distal epiphysis can be preserved. In 13 patients, VFG was used alone, whereas in five patients, a massive allograft was used. Our policy was to use VFG combined with a massive allograft in patients undergoing juxta-articular joint-sparing resections in which proximal osteotomy was performed close to the anatomic neck of the humerus to obtain more stable fixation and better tendinous reattachment of the rotator cuff and deltoid. All 18 patients who were treated with a VFG were available for follow-up at a minimum of 2 years (median follow-up 176 months, range 26 to 275 months), and although three have not been seen in the past 5 years and are not known to have died, they had 172, 163, and 236 months of follow-up, and were included. The median age at surgery was 25 years (range 2 to 63 years), the median humeral resection length was 15 cm (range 8 to 21 cm), and the median fibular length was 16 cm (range 12 to 23 cm). Complications and functional scores were ascertained by chart review that was performed by an individual not involved in patient care. Functional results were assessed with the MSTS score (range 0 to 30), the ASES score (range 0 to 100), and the Constant score (range 0% to 100%). Survivorship was estimated using a Kaplan-Meier survivorship estimator, which was suitable because there were few deaths in this series. RESULTS: Seven patients underwent a revision procedure (one radial nerve transient palsy because of screw impingement, four nonunions in three patients with one humeral head avascular necrosis, treatment for screw-related pain in one patient, and two VFG fractures), and one patient underwent VFG removal. Donor site complications were observed in four patients (one ankle valgus deformity and three claw toes-the first toe in two patients and the other toes in the third). At the final clinical control, at a median follow-up of 176 months (range 26 to 275 months), the median MSTS score was 30 of 30 (range 28 to 30), the median ASES score was 98.3 (range 93 to 100), and the median Constant score was 93.5% (range 79% to 100%). Revision-free survival was 71% (95% CI 53% to 96%) at 5 years and 57% (95% CI 37% to 88%) at 10 and 15 years; VFG removal-free survival was 94% (95% CI 83% to 100%) at 5, 10, and 15 years. CONCLUSION: VFG appears to be an effective reconstructive option after humeral intercalary resection for primary bone tumors. These are complex procedures and should be performed by an experienced team of surgeons who recognize that complications may occur frequently in the first years after the procedure. The frequency of mechanical complications observed in the first 5 years postoperatively may be lessened by using long spanning-plate fixation, and if successful, this reconstruction provides a long-term, durable reconstruction with excellent functional results. LEVEL OF EVIDENCE: Level IV, therapeutic study.

[Evaluation of the effect of cattle calcined bone grafting material to repair alveolar bone defect after tooth extraction].

PURPOSE: To verify the efficacy and safety of calcined cattle bone grafting material in filling alveolar bone defect after tooth extraction. METHODS: A randomized, bind, parallel, positive-control multicenter clinical trial was conducted. A total of 280 subjects were randomly assigned to either the experimental group (calcined cattle bone group) or control group (Bio-Oss group) equally. The main efficacy indicator was the imaging changes 24 weeks after material implantation. Secondary efficacy indicators were wound healing, rejection, bone metabolism, post-filling symptoms and signs of bone infection. The safety of material was assessed by the incidence of adverse events and serious adverse events. SAS 8.2 software package was used for statistical analysis. RESULTS: A total of 280 cases were included, of them 267 cases completed the study while 13 cases fell off. The effective rate of FAS(PPS) was 90.58%(97.46%) in the experimental group and 87.05% (95.04%) in the control group. The difference of effective rate between the experimental group and control group (95%CI) was 3.53% (-3.88%, 10.94%) of FAS, 2.42% (-2.38%, 7.22%) of PPS, and there was no significant difference between the two groups. The incision healing of the two groups was good, and the incidence of rejection, bone infection signs, post-filling symptoms and bone metabolic changes was very low. The incidence of adverse events was similar in the two groups, and no serious adverse events related to the study materials occurred. CONCLUSIONS: The efficacy of calcined cattle bone grafting material in filling alveolar bone defect after tooth extraction is not inferior to that of Bio-Oss, and it is safe and effective for alveolar bone defect repair.

Arthroscopic versus open cancellous bone grafting for scaphoid delayed/nonunion in adults (SCOPE-OUT): study protocol for a randomized clinical trial.

BACKGROUND: Scaphoid non-union results in pain and decreased hand function. Untreated, almost all cases develop degenerative changes. Despite advances in surgical techniques, the treatment is challenging and often results in a long period with a supportive bandage until the union is established. Open, corticocancellous (CC) or cancellous (C) graft reconstruction and internal fixation are often preferred. Arthroscopic assisted reconstruction with C chips and internal fixation provides minimal trauma to the ligament structures, joint capsule, and extrinsic vascularization with similar union rates. Correction of deformity after operative treatment is debated with some studies favouring CC, and others found no difference. No studies have compared time to union and functional outcomes in arthroscopic vs. open C graft reconstruction. We hypothesize that arthroscopic assisted C chips graft reconstruction of scaphoid delayed/non-union provides faster time to union, by at least a mean 3 weeks difference. METHODS: Single site, prospective, observer-blinded randomized controlled trial. Eighty-eight patients aged 18-68 years with scaphoid delayed/non-union will be randomized, 1:1, to either open iliac crest C graft reconstruction or arthroscopic assisted distal radius C chips graft reconstruction. Patients are stratified for smoking habits, proximal pole involvement and displacement of > / < 2 mm. The primary outcome is time to union, measured with repeated CT scans at 2-week intervals from 6 to 16 weeks postoperatively. Secondary outcomes are Quick Disabilities of the Arm, Shoulder and Hand (Q-DASH), visual analogue scale (VAS), donor site morbidity, union rate, restoration of scaphoid deformity, range of motion, key-pinch, grip strength, EQ5D-5L, patient satisfaction, complications and revision surgery. DISCUSSION: The results of this study will contribute to the treatment algorithm of scaphoid delayed/non-union and assist hand surgeons and patients in making treatment decisions. Eventually, improving time to union will benefit patients in earlier return to normal daily activity and reduce society costs by shortening sick leave. TRIAL REGISTRATION: ClinicalTrials.gov NCT05574582. Date first registered: September 30, 2022. Items from the WHO trial registry are found within the protocol.