Efficacy and safety of autologous or allogeneic mesenchymal stromal cells from adult adipose tissue expanded and combined with tricalcium phosphate biomaterial for the surgical treatment of atrophic nonunion of long bones: a phase II clinical trial.

BACKGROUND: Autologous bone grafting is the standard treatment for the surgical management of atrophic nonunion of long bones. Other solutions, such as bone marrow mesenchymal stem cells (BM-MSC) combined with phospho-calcium material, have also been used. Here we evaluate the safety and early efficacy of a novel procedure using autologous or allogenic adipose tissue mesenchymal stromal cells (AT-MSC) seeded in a patented tricalcium phosphate-based biomaterial for the treatment of bone regeneration in cases of atrophic nonunion. METHODS: This was a prospective, multicentric, open-label, phase 2 clinical trial of patients with atrophic nonunion of long bones. Biografts of autologous or allogenic AT-MSC combined with a phosphate substrate were manufactured prior to the surgical procedures. The primary efficacy was measured 6 months after surgery, but patients were followed for 12 months after surgery and a further year out of the scope of the study. All adverse events were recorded. This cohort was compared with a historical cohort of 14 cases treated by the same research team with autologous BM-MSC. RESULTS: A total of 12 patients with atrophic nonunion of long bones were included. The mean (SD) age was 41.2 (12.1) years and 66.7% were men. Bone healing was achieved in 10 of the 12 cases (83%) treated with the AT-MSC biografts, a percentage of healing similar (11 of the 14 cases, 79%) to that achieved in patients treated with autologous BM-MSC. Overall, two adverse events, in the same patient, were considered related to the procedure. CONCLUSIONS: The results of this study suggest that AT-MSC biografts are safe for the treatment of bone regeneration in cases of atrophic nonunion and reach high healing rates. TRIAL REGISTRATION: Study registered with EUDRA-CT (2013-000930-37) and ClinicalTrials.gov (NCT02483364).

Recycled bone grafts treated with extracorporeal irradiation or liquid nitrogen freezing after malignant tumor resection.

INTRODUCTION: Recycled bone autografts prepared using extracorporeal irradiation (ECIR) or liquid nitrogen freezing (LNF) methods have been used for the reconstruction of skeletal elements after wide resection of sarcomas involving bone tissues. Few reports include long-term follow-up data for histological analyses of recycled autografts, particularly in the case of ECIR autografts. MATERIALS: A total of 34 malignant bone and soft tissue tumors were resected and reconstructed using 11 ECIR- and 23 LNF-recycled autografts; the mean postoperative follow-ups were 14 and 8 years, respectively. ECIR was used for either osteosarcomas or Ewing sarcomas, whereas in addition to these tumors LNF was used for chondrosarcomas and soft tissue sarcomas involving bone tissues. Recycled bone was implanted as total bone, osteoarticular, or intercalary grafts, with or without prosthesis or vascularized fibular grafts. RESULTS: The 10-year graft survival rate was similar between groups, 81.8% using ECIR and 70.2% using LNF. There were no autograft-related tumor recurrences in either group. Graft survival was unrelated to type of graft or additional procedures. Complication rates tended to be higher using ECIR (64%) compared with LNF (52%) and the infection rate was significantly higher with ECIR (27%) versus LNF (0%). At the final assessment, plain radiographs revealed original recycled bone was present in 7 of 11 ECIR cases and in zero cases treated with LNF autografts, indicating that recycled bone treated with LNF autografts was remodeled into new bone. Histological examination of ECIR-treated bones revealed a delayed and incomplete endochondral ossification process, necrosis and empty lacunae. Conversely, LNF autografts showed remodeled bones with normal trabecular structures. CONCLUSIONS: ECIR and LNF treatment of autografts provided adequate tumor control with acceptable clinical results as a reconstruction method.

Recombinant bone matrix maintains the graft space, induces vascularized bone regeneration and preserves canine tooth extraction socket structure.

AIM: Recombinant bone matrix (RBM) is a newly conceived and engineered porous bone graft granule of average size 600 µm composed of purified recombinant collagen peptide. We sought to examine the behaviour with time of RBM that was grafted in the canine tooth extraction socket. MATERIALS AND METHODS: The canine tooth extraction socket of the hemisectioned mandibular third premolar distal root was grafted with RBM granules, whereas the opposite side extraction socket served as non-grafted control. The mandibular samples were harvested at 1, 3 and 6 months of healing and subjected to micro-CT imaging and decalcified paraffin-embedded histology. Separately, the effect of RBM was compared with that of deproteinized cancellous bovine bone (DCBB) and bovine atelocollagen plug (BACP) in the canine tooth extraction model at 3 months of healing. RESULTS: RBM maintained the grafted space in the socket and the gingival connective tissue until new bone was formed within its porous space. The regenerated bone was highly vascularized and continued to mature, while RBM was completely bioresorbed by 6 months. The buccal and lingual alveolar ridge heights of the RBM-grafted extraction socket was better preserved than those of non-grafted control sockets. The degree of socket preservation by RBM was equivalent to that by DCBB, although their healing mechanisms were different. CONCLUSIONS: This study demonstrated that RBM induced controlled active bone regeneration and preserved the extraction socket structure in a canine model. Bioresorbable RBM engineered without animal or human source materials presents a novel bone graft category with robust bone regenerative property.

Vitality of autologous retromolar bone grafts for alveolar ridge augmentation after a 3-months healing period: A prospective histomorphometrical analysis.

OBJECTIVES: The incorporation of retromolar bone grafts used for alveolar ridge augmentation is not well understood. This prospective observational study aims to supply histomorphometrical data from bone graft biopsies taken at the time of retrieval and after a 3-month healing period using patient-matched biopsies. MATERIALS AND METHODS: In 17 patients, trephine biopsies of the graft were acquired at the time of graft retrieval and after a 3-month healing period. The biopsies were compared histomorphometrically regarding the number of osteocytes, appearance of osteocyte lacunae, quantity, surface area, and activity of the Haversian canals. RESULTS: All grafts appeared clinically stable after screw removal and 17 implants were placed. Histomorphometric analysis revealed no significant difference in the number of osteocytes (p = .413), osteocyte lacunae (p = .611), the ratio of filled/empty osteocyte lacunae (p = .467) and active Haversian canals (p = .495) between the biopsies retrieved after a 3-months healing period with those at the time of grafting. The only significant difference was noted in the mean surface area of the Haversian canals (p = .002). Specifically, the grafts post 3-month healing showed a significantly larger mean area (0.069 mm2) compared to the time of grafting (0.029 mm2). CONCLUSION: This study demonstrates, compared to other data, a high rate of vital structures in retromolar bone block grafts after 3 months of healing, exhibiting the same histological features in comparison to the biopsies from the native alveolar ridge. Standard histomorphometrical parameters, e.g., the amount of filled or empty osteocyte lacunae for the description of the vitality of the graft need to be reappraised.

Hard and soft tissue alterations using dual-zone concept versus connective tissue graft at maxillary immediate implant placement: A 1-year randomized clinical and volumetric trial.

OBJECTIVES: To evaluate the esthetic outcome, as well as clinical, radiographic, and volumetric tissue alterations 1 year after immediate implant placement (IIP) with connective tissue grafting (CTG) versus dual-zone concept (DZ) at sites with thin labial bone in the esthetic zone. MATERIALS AND METHODS: This randomized clinical trial included 30 patients treated with IIP simultaneous with either CTG or DZ (n = 15 each). Pink esthetic score (PES) was assessed 6 months after crown placement as the primary outcome. Amount of bone labial to the implant, labio-palatal ridge reduction, and crestal bone changes were measured via CBCT after 1 year. Volumetric analysis of linear labial soft tissue contour, interdental, and mid-facial soft tissue level changes, and total volume loss (mm3) were measured after 1 year. RESULTS: Similar PES was observed in the CTG (12.53 ± 1.13) and DZ (12.13 ± 1.55) groups, with no significant difference (p = 0.42). Likewise, there were no statistically significant differences found between the two groups in labio-palatal bone reduction (mm&%), interdental papillae, and mid-facial gingival levels (p > 0.05). However, the mean vertical crestal bone changes in the CTG and DZ groups were -1.1 ± 0.6 mm and 0.2 ± 1.0 mm, respectively, with a statistically significant difference (p = 0.0002). Moreover, CTG revealed less linear and total volume (mm3) loss in the labial soft tissue which was statistically significant compared to DZ (p = 0.007). CONCLUSION: Both groups demonstrated the same PES, nevertheless, volumetric analysis revealed twice total labial volume loss in DZ compared to CTG. It might be concluded that the use of CTG with IIP caused less horizontal reduction in the supra-implant complex compared to the DZ.

Bone volume and height changes for lateral window sinus floor elevation using two types of deproteinized bovine bone mineral: A retrospective cohort study of 1-4 years.

OBJECTIVE: To compare bone volume and height changes of two types of deproteinized bovine bone mineral (DBBM) for lateral window sinus floor elevation (LSFE) with simultaneous implant placement. MATERIALS AND METHODS: This retrospective cohort study involved 72 patients who underwent LSFE using low-temperature sintered cancellous bone-derived DBBM (C-DBBM) or high-temperature two-step sintered epiphyseal-derived DBBM (E-DBBM). Cone-beam computed tomography (CBCT) was acquired preoperatively, immediately postoperatively, 6 months and 1-4 years post-surgery. Bone volume (BV), apical bone height (ABH), endo-sinus bone gain (ESBG), and crestal bone level (CBL) were evaluated through three-dimensional fitting and superimposition. Linear mixed models (LMM) were employed to analyze factors influencing the reduction of BV (ΔBV) and ESBG (ΔESBG). RESULTS: The E-DBBM group showed no significant change in BV 1-4 years post-surgery, while the C-DBBM group demonstrated a significant reduction (p = .006) with volume stability of 85.86%. Bone height in the E-DBBM group increased at 6 months and subsequently decreased at 1-4 years (p = .003). In the C-DBBM group, it decreased at 6 months (p = .014), then further decreased at 1-4 years (p = .001). ΔESBG was lower in the E-DBBM group than the C-DBBM group from immediate postoperative to 1-4 years (p = .009). LMM showed graft material type was the primary factor influencing ΔBV (p = .026) and ΔESBG (p = .003). CONCLUSIONS: Within the limitations of this study, both types of DBBM could achieve favorable clinical outcomes. E-DBBM demonstrated enhanced stability in maintaining bone volume and height.

Cranial Repair in Children: Techniques, Materials, and Peculiar Issues.

Cranial repair in children deserves particular attention since many issues are still controversial. Furthermore, literature data offer a confused picture of outcome of cranioplasty, in terms of results and complication rates, with studies showing inadequate follow-up and including populations that are not homogeneous by age of the patients, etiology, and size of the bone defect.Indeed, age has merged in the last years as a risk factor for resorption of autologous bone flap that is still the most frequent complication in cranial repair after decompressive craniectomy.Age-related factors play a role also when alloplastic materials are used. In fact, the implantation of alloplastic materials is limited by skull growth under 7 years of age and is contraindicated in the first years if life. Thus, the absence of an ideal material for cranioplasty is even more evident in children with a steady risk of complications through the entire life of the patient that is usually much longer than surgical follow-up.As a result, specific techniques should be adopted according to the age of the patient and etiology of the defect, aiming to repair the skull and respect its residual growth.Thus, autologous bone still represents the best option for cranial repair, though limitations exist. As an alternative, biomimetic materials should ideally warrant the possibility to overcome the limits of other inert alloplastic materials by favoring osteointegration or osteoinduction or both.On these grounds, this paper aims to offer a thorough overview of techniques, materials, and peculiar issues of cranial repair in children.

Drug eluting bioactive glass ceramics for fusion in spondylodiscitis: a pilot study.

Retrospective observational study. To determine the efficacy and safety of bioactive glass ceramics mixed with autograft in the treatment of spondylodiscitis. Thirty-four patients with spondylodiscitis underwent surgery using autologous bone graft augmented by antibiotic loaded bioactive glass ceramic granules. Twenty-five patients aging 6 to 77, completed 1-year follow-up. The lumbosacral junction was affected in 3, lumbar spine in 13, one each in the dorso-lumbar junction and sacrum, and 7 dorsal spines. The organism isolated was Mycobacterium tuberculosis in 15, Methicillin sensitive Staphylococcus aureus (MSSA) in 4, Pseudomonas aeruginosa in 4, Klebsiella pneumoniae in one, Burkholderia pseudomallei in 1, and mixed infections in 2. All patients had appropriate antibiotic therapy based on culture and sensitivity. Clinical and radiological evaluation of all the patients was done at 6 weeks, 3 months, 6 months, and 12 months after the surgery. Twenty-three patients improved clinically and showed radiographic fusion between 6 and 9 months. The patient with Burkholderia infection died due to fulminant septicemia with multi organ failure while another patient died at 9 months due to an unrelated cardiac event. The mean Visual Analogue Score (VAS) at the end of 1-year was 2 with radiological evidence of fusion in all patients. There were no re-infections or discharging wounds, and the 30-day re-admission rate was 0. Bioactive glass ceramics is a safe and effective graft expander in cases of spondylodiscitis. The absorption of antibiotics into the ceramic appears to help the elimination of infection.

Does type of bone graft matter? A retrospective review of the use of biological bone grafts in patients undergoing elective 1-3 level spinal interbody fusion.

OBJECTIVE: There is a lack of strong evidence for use of expensive bone substitutes. This study compares perioperative data and patient reported quality-of-life outcomes across the varied types of bone graft extenders. The study analyzes the existing Quality and Outcomes Database and evaluates patient reported outcomes for 1-3 level lumbar fusion procedures comparing across different types of biologics bone graft. METHODS: We retrospectively analyzed a prospectively collected data registry. Bone graft implant data were collected and grouped into the following categories: (1) Autograft with basic allograft (2) Enhanced, synthetic, or cellular allograft (3) Use of BMP. Preoperative and 1 year patient reported outcomes and perioperative data from the prospective collected registry were analyzed. RESULTS: There were 384 patients included in this study. There were 168 (43.8%) patients in group 1, 133 (34.6%) patients in group 2, and 83 (21.6%) in group 3. There were no group differences in baseline or 1 year back pain, leg pain, ODI, or EQ-5D. The GLM Repeated Measures results indicate a significant difference within each of the three groups between the preoperative and postoperative measures for back pain, leg pain, ODI, and EQ-5D. The change over time was not significantly different between the groups. CONCLUSIONS: Bone graft extenders are a significant contributor to the cost of lumbar fusion. This study demonstrates no difference in preoperative, and 1 year patient reported outcomes between the three groups. There was no significant difference in rate of reoperations across the three groups.

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

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

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.

Free iliac crest grafting technology for the management of critical-sized tibial bone defect.

OBJECTIVE: To introduce the method and experience of treating critical-sized tibial bone defect by taking large iliac crest bone graft. METHODS: From January 2020 to January 2022, iliac crest bone grafting was performed in 20 patients (10 men and 10 women) with critical-sized tibial bone defect. The mean length of bone defect was 13.59 ± 3.41. Bilateral iliac crest grafts were harvested, including the inner and outer plates of the iliac crest and iliac spine. The cortical bone screw was used to integrate two iliac bone blocks into one complex. Locking plate was used to fix the graft-host complex, supplemented with reconstruction plate to increase stability when necessary. Bone healing was evaluated by cortical bone fusion on radiographs at follow-up, iliac pain was assessed by VAS score, and lower limb function was assessed by ODI score. Complications were also taken into consideration. RESULTS: The average follow-up time was 27.4 ± 5.6 (Range 24-33 months), the mean VAS score was 8.8 ± 1.9, the mean ODI score was 11.1 ± 1.8, and the number of cortical bone fusion in the bone graft area was 3.5 ± 0.5. Satisfactory fusion was obtained in all cases of iliac bone transplant-host site. No nonunion, shift or fracture was found in all cases. No infection and bone resorption were observed that need secondary surgery. One patient had dorsiflexion weakness of the great toe. Hypoesthesia of the dorsal foot was observed in 2 patients. Ankle stiffness and edema occurred in 3 patients. Complications were significantly improved by physical therapy and rehabilitation training. CONCLUSION: For the cases of critical-sized tibial bone defect, the treatment methods are various. In this paper, we have obtained satisfactory results by using large iliac bone graft to treat bone defect. This approach can not only restore the integrity of the tibia, but also obtain good stability with internal fixation, and operation skills are more acceptable for surgeons. Therefore, it provides an alternative surgical method for clinicians.

Unilateral biportal endoscopic lumbar interbody fusion (ULIF) versus endoscopic transforaminal lumbar interbody fusion (Endo-TLIF) in the treatment of lumbar spinal stenosis along with intervertebral disc herniation: a retrospective analysis.

OBJECTIVE: This study aims to compare the clinical effects and imaging data of patients who underwent endoscopic transforaminal lumbar interbody fusion (Endo-TLIF) with those who received unilateral biportal endoscopic lumbar interbody fusion (ULIF). METHODS: A retrospective analysis was conducted on the clinical data of 69 patients presenting with typical intermittent claudication and signs and symptoms indicative of unilateral lower extremity nerve root compression, meeting inclusion criteria between April 2022 and June 2022. Among the cohort, 35 patients underwent ULIF group, while 34 patients underwent Endo-TLIF group. We compared perioperative parameters, including intraoperative blood loss, duration of hospital stay, and operation time between the two groups. Pre-operative and post-operative changes in the height and cross-sectional area of the target intervertebral space were also compared between the groups. Finally, we evaluated bone graft size and interbody fusion rates at 6 and 12 months post-surgery using the Brantigan scoring system. RESULTS: The ULIF group had significantly shorter operative times compared to the Endo-TLIF group (P < 0.05). Conversely, the Endo-TLIF group exhibited significantly shorter hospital stays compared to the ULIF group (P < 0.05). However, there were no significant differences in intraoperative bleeding between the two groups (P > 0.05). Furthermore, both groups exhibited postoperative increases in vertebral canal volume compared to baseline (P < 0.05), with no significant difference in the change in the cross-sectional area of the target intervertebral space between the two surgical methods (P > 0.05). Interbody fusion rates were comparable between the two groups at both 6 and 12 months after surgery (P > 0.05). Lastly, the ULIF group had a significantly larger area of bone graft than the Endo-TLIF group (P < 0.05). CONCLUSION: In summary, the ULIF technique, as a novel spinal endoscopy approach, is a safer and more effective minimally invasive surgical method for addressing lumbar spinal stenosis and intervertebral disc herniation in patients. Both surgical methods have their own advantages and drawbacks. With the development of technology and related instruments, the limitations of both techniques can be mitigated for to a certain extent, and they can be applied by more doctors in diverse medical fields in the future.

Biportal endoscopic bone graft repair and percutaneous screw fixation for lumbar spondylolysis-technical note and clinical outcomes.

BACKGROUND: Lumbar spondylolysis involves a bony defect in the vertebral pars interarticularis, predominantly affecting the lower lumbar spine. This condition is a significant etiological factor in lumbar instability and recurrent lower back pain, particularly in young individuals. While conservative treatments are the primary intervention, they often fail to provide relief, necessitating surgical approaches. Notwithstanding, executing bone grafting and fixation in the pars interarticularis defect simultaneously through minimally invasive surgery remains challenging. METHOD: This study elucidates the biportal endoscopic spinal surgery (BESS) technique, innovatively applied for bone graft repair and percutaneous cannulated screw fixation in a patient with lumbar spondylolysis. We offer a detailed walkthrough of the technical procedures supplemented with follow-up radiographic evidence. RESULTS: The BESS technique facilitated meticulous clearance of the defect site, coupled with bone grafting and cannulated screw fixation, effectively addressing lumbar spondylolysis through a minimally invasive approach. This method holds promise for achieving substantial osseous fusion at the vertebral pars interarticularis defect site. CONCLUSION: The BESS procedure for lumbar spondylolysis ensures a clean and prepared defect site for grafting and encourages successful osseous fusion, spotlighting its potential as a viable surgical strategy in managing this condition.

A bone graft from the tibial resection or patella that rectified a tibial over-resection reliably healed and improved clinical outcome scores: A retrospective study of kinematically aligned TKA.

PURPOSE: During kinematically aligned (KA) total knee arthroplasty (TKA), the surgeon may need to rectify an over-resection of the medial, lateral or posterior tibia. This study tested the hypothesis that a bone graft taken from the tibial resection or patella and impacted beneath a tibial baseplate would heal, regardless of whether the tibial component and knee were in outlier ranges according to mechanical alignment (MA) criteria. The study also tested the hypothesis that the Oxford Knee Score (OKS) and Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) would improve beyond the substantial clinical benefit and that the source and thickness of the bone graft would not influence their improvement. METHODS: This retrospective study radiographically assessed the healing of a bone graft from the tibial resection (n = 19) or patella (n = 10) in 29 KA TKAs (18 females, mean age 65 years). The tibial component and knee alignment were categorized as in-range or outliers based on reported MA criteria for bone graft healing and implant survival. The one-sample t test identified differences in the improvement of the OKS and KOOS JR from their reported substantial clinical benefit of 16 and 20 points, respectively. RESULTS: At an average follow-up of 37 months, all bone grafts healed even though ≥55% of tibial components and 34% of knees were varus outliers according to MA criteria for bone healing and implant survival. Amongst the 29 patients, the mean OKS and KOOS JR improvements of 25 ± 11 and 47 ± 21 points, respectively, surpassed the threshold of their respective substantial clinical benefit (p < 0.01) and were not influenced by the bone graft's source and thickness (p ≥ 0.51). CONCLUSIONS: During cemented KA TKA, the surgeon can use a bone graft from the tibial resection or patella to rectify a tibial over-resection. This technique led to consistent bone healing and improved outcome scores. LEVEL OF EVIDENCE: Level IV.

All-soft tissue quadriceps tendon autograft and bone-patellar tendon-bone autograft demonstrate no significant ACL tunnel widening: An MRI comparison.

PURPOSE: This study sought to quantify the tunnel widening associated with quadriceps tendon (QT) autograft after anterior cruciate ligament reconstruction (ACLR) and compare it to bone-patellar tendon-bone (BTB) autografts. METHODS: A retrospective review of each ACLR performed at a single academic institution from 2011 to 2021 were reviewed. Subjects with repeat ipsilateral knee magnetic resonance imaging (MRI) studies performed after ACLR were included. Two reviewers independently measured the maximum diameter of the femoral and tibial tunnels 1 cm from the aperture. Tunnel widening was calculated as the difference between the initial drilled diameter and the measured diameters. RESULTS: Seventy-five patients (38 BTB and 37 QT autografts) were identified including 42 females and 33 males. With respect to graft type (QT vs. BTB), there was no statistically significant difference in median patient age (19.0 (16.0-31.5) years vs. 20.0 (16.8-30.0) years respectively; p = n.s.) or median time to MRI (12.0 [9.0-19.5] months vs. 13.0 [7.0-43.3] months respectively, p = n.s.). Mean tunnel diameter changes or widening was statistically significantly greater for QT autografts than BTB autografts at the tibial tunnel: (0.4 [±0.6] mm] vs. -0.4 [±1.1 mm; p < 0.001). Similarly, the mean tunnel diameter change was also significantly greater at the femoral tunnel for QT compared to BTB. (0.2 [±0.6] mm vs. -0.4 [±0.8] mm; p < 0.001) However, no patients with QT grafts demonstrated tibial or femoral tunnel diameters >12 mm. CONCLUSION: Although QT autografts had a statistically significant greater amount of tunnel widening compared to BTB autografts; the mean tibial and femoral net widening of 0.4 mm and 0.2 mm, respectively, does not meet previously reported clinically significant values. Thus, the tunnel widening presented in this study is unlikely to affect clinical outcomes and should not preclude the use of either graft. LEVEL OF EVIDENCE: Level III (Retrospective comparative study).

Immediately placed implants using simvastatin and autogenous tooth graft combination in periodontally compromised sites: a randomized controlled clinical trial.

OBJECTIVES: The present study aimed to assess clinically and radiographically the usage of autogenous tooth bone graft (ATBG) combined with and without Simvastatin (SMV) around immediately placed dental implants in periodontally compromised sites. METHODS: Thirty-nine patients required a single extraction of periodontally compromised tooth were divided into three groups (13 patients each). Group I received immediate implant placement (IIP) without grafting. Group II received IIP with ATBG filling the gap around IIP. Group III received SMV gel mixed with ATBG around IIP. Radiographic changes were reported at the baseline, 6-, and 12-months post-surgery. RESULTS: All implants achieved the success criteria with no complications. At 6- and 12-months post-surgery, group III showed a statistically lower mean ridge width loss compared to Group I and Group II (P < .001). Group II revealed less reduction in the mean alveolar ridge width compared to group I (P < .001). Group III showed a statistically significantly less MBL loss than group I and group II (P < .001). All groups showed a statistically significant increase in BD gain compared to baseline (P < .001). Group III showed statistically significant high BD compared to group II (P < .001). Group II showed statistically significantly higher mean BD gain than that of group I (P < .001). CONCLUSION: SMV combined with ATBG boosts the hard tissue parameters around dental implants over ATBG alone. Clinical trial registration was on August 1, 2021 (NCT04992416). CLINICAL RELEVANCE: ATBG with SMV in periodontally compromised sites could improve implant osseointegration and promote favorable changes in peri-implant tissues.

Ginger extract loaded Fe2O3/MgO-doped hydroxyapatite: Evaluation of biological properties for bone-tissue engineering.

Since antiquity, the medicinal properties of naturally sourced biomolecules such as ginger (Zingiber officinale) extract are documented in the traditional Indian and Chinese medical systems. However, limited work is performed to assess the potential of ginger extracts for bone-tissue engineering. Our work demonstrates the direct incorporation of ginger extract on iron oxide-magnesium oxide (Fe2O3 and MgO) co-doped hydroxyapatite (HA) for enhancement in the biological properties. The addition of Fe2O3 and MgO co-doping system and ginger extract with HA increases the osteoblast viability up to ~ 1.4 times at day 11. The presence of ginger extract leads to up to ~ 9 times MG-63 cell viability reduction. The co-doping does not adversely affect the release of ginger extract from the graft surface in the biological medium at pH 7.4 for up to 28 days. Assessment of antibacterial efficacy according to the modified ISO 22196: 2011 standard method indicates that the combined effects of Fe2O3, MgO, and ginger extract lead to ~ 82 % more bacterial cell reduction, compared to the control HA against S. aureus. These ginger extract-loaded artificial bone grafts with enhanced biological properties may be utilized as a localized site-specific delivery vehicle for various bone tissue engineering applications.

The effect of a barrier membrane on the incorporation of deproteinized bovine bone mineral (DBBM) in experimental defects at the time of early implant placement. A preclinical study.

OBJECTIVES: This study aimed to assess membrane use with a bone substitute graft for guided bone regeneration (GBR) in experimental dehiscence defects. MATERIALS AND METHODS: Maxillary second incisors (I2) in 9 dogs were extracted. Six weeks later, implants were inserted and experimental dehiscence defects (5 × 3 mm) created on the buccal aspect. The defects and surrounding bone were grafted with deproteinized bovine bone mineral. One side (test) was covered with a resorbable collagen membrane whereas the contralateral side (control) was not. After 6 weeks, histomorphometrical analysis was performed to evaluate: (a) first bone-to-implant contact (fBIC), (b) buccal bone thickness at 1 mm increments from implant shoulder, (c) regenerated area (RA), (d) area and percentages of new bone (B), bone substitute (BS) and mineralized tissue (MT). RESULTS: The histological appearance was similar between test and control sites. At central and lateral sections, there were no differences between groups for fBIC, buccal bone thickness, RA, BS, B, %B, MT and %MT. At central sections, membrane use favoured more %BS and %MT (p = 0.052). There was significantly more B, %B and MT at lateral compared to central sections. CONCLUSIONS: Membrane use tended to retain more bone substitute, but had no effect on new bone ingrowth. Lateral sections showed significantly more bone ingrowth and mineralized tissue compared to central sections, confirming that new bone ingrowth takes place mainly from the lateral walls of the defect. CLINICAL RELEVANCE: Preclinical research to clarify the dynamics of bone regeneration in GBR procedures is relevant in clinical practice.

Periodontal regenerative therapy using recombinant human fibroblast growth factor (rhFGF)-2 in combination with carbonate apatite granules or rhFGF-2 alone: 12-month randomized controlled trial.

OBJECTIVES: This randomized controlled trial compared the outcomes of recombinant human fibroblast growth factor (rhFGF)-2 plus carbonate apatite (CO3Ap) granules with rhFGF-2 alone in the treatment of intrabony periodontal defects. MATERIALS AND METHODS: Patients with Stage III Grade B/C periodontitis who had completed initial periodontal therapy and had intrabony defects with a depth of ≥ 3 mm were included. Defects were treated solely with rhFGF-2 (control) or rhFGF-2 plus CO3Ap (test). Periodontal parameters and a patient-reported outcome measure (PROM) were assessed at baseline, at 6, 9 and 12 months postoperatively. The primary outcome was the change in clinical attachment level (CAL) from baseline to 12 months postoperatively. Using the Friedman test with Dunn's post-test, intragroup data were compared over time, and Mann-Whitney U test was used to assess intergroup data at each time point. RESULTS: Forty-eight sites in 38 patients were subjected to analysis. At 12 months postoperatively, CAL in both groups showed a significant improvement from baseline (p < 0.001). CAL gain was 3.4 ± 1.3 mm in the test group and 3.2 ± 1.2 mm in the control group, with no significant intergroup difference (p = 0.567). Radiographic bone fill in the test group (67.2%) was significantly greater than in the control group (32.4%) (p < 0.001). PROM scores showed no difference between groups. CONCLUSIONS: At 12 months, the outcomes including CAL gain and PROM showed no significant differences between groups, although the combination treatment enhanced radiographic bone fill. CLINICAL RELEVANCE: The use of rhFGF-2 (with/without CO3Ap) could lead to significant improvement in clinical parameters in the treatment of intrabony periodontal defects. The benefit of adding CO3Ap to rhFGF-2 therapy needs further evaluation. CLINICAL TRIAL REGISTRATION NUMBER: The University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) : UMIN000040783.