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"Bone Transplantation - methods"
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Development of a per-operative procedure for concentrated bone marrow adjunction in postero-lateral lumbar fusion
by
Odri, G. A.
,
Heymann, D.
,
Delecrin, J.
in
Bone Marrow Transplantation - methods
,
Bone Transplantation - methods
,
Female
2012
Purpose
Addition of bone marrow to the bone graft in the postero-lateral lumbar arthrodesis is a widely used technique. Bone marrow brings stem cells and growth factors contained in the platelets, favorable for bone growth. Adjunction of concentrated bone marrow should create better conditions and may increase bone growth.
Methods
Simple blind randomized clinical, prospective, monocentric trial was conducted. Fifteen patients underwent lumbar arthrodesis. During surgery, a fraction of the bone marrow harvested was centrifuged. One side received this concentrate with autologous bone and ceramics; the other side received the same graft with unconcentrated bone marrow. A quantitative study, realised with a volume calculating software on CT-scan images, determined the cortical bone volume in the graft post-operatively and at 3 months. The osteoprogenitor cells, nucleated cells and platelet concentrations were determined.
Results
The biological study found an average concentration of six times for the nucleated cells, 3.5 times for the platelets and 2.2 times for the osteoprogenitor cells. The comparison of the mean cortical bone volumes post-operatively and at 3 months was not significantly different.
Conclusions
Despite the concentration obtained, there was no increase of bone growth by adding concentrated bone marrow. However, the number of stem cells in bone marrow was low and maybe a stronger concentration is needed to obtain a difference. The 3D reconstruction of the graft and the analysis of the graft’s volume using a novel software was efficient according to the similarity of the graft’s volume post-operatively in all patients.
Journal Article
i-Factor™ Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study
by
Vaccaro, Alexander R
,
Fehlings, Michael G
,
Kopjar, Branko
in
Adult
,
Autografts
,
Bone Substitutes - therapeutic use
2018
Abstract
BACKGROUND
i-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative.
OBJECTIVE
To report 2-yr follow-up.
METHODS
Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes.
RESULTS
At 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively (P = .2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft; P = .7869). Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft; P = .1448); Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p = .2763); Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft; P = .1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft; P = .4507), and SF36v2 Mental Component Score improved 7.88 (i-FactorTM) and 7.53 (autograft; P = .9872). The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P = .0302). Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation (P = .3411). There were no allergic reactions associated with i-Factor™.
CONCLUSION
Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery.
Journal Article
Equal rates of bone healing and reduced surgical time with iliac crest allograft compared to autograft in medial opening wedge high tibial osteotomy: a randomized controlled clinical trial
by
Prinz, Rafael Augusto Dantas
,
da Palma, Idemar Monteiro
,
de Paula, Rafael Erthal
in
Adult
,
Allografts
,
Archives & records
2024
Introduction
Iliac crest autograft is frequently used to fill in bone defects after osteotomies. Nonetheless, surgery for bone autograft procurement is associated with morbidity and pain at the donor site. Alternatives to it have been explored, but there is no consensus to guide their application as a routine practice in several orthopedic procedures. Thus, this study was designed to compare the efficacy and safety between iliac crest autograft and allograft in medial opening wedge high tibial osteotomy.
Materials and methods
Forty-seven patients with a symptomatic unilateral genu varum and an indication for high tibial osteotomy were randomly assigned to receive either autograft or allograft to fill the osteotomy site. Operative time, bone healing, and complication rates (delayed union, nonunion, superficial and deep infection, loss of correction, and hardware failure) were recorded after a one-year follow-up. Data were expressed as Mean ± Standard Deviation and considered statistically significant when
p
< 0.05.
Results
The time to radiologic union was similar between both groups (Allograft: 2.38 ± 0.97 months vs. Autograft: 2.45 ± 0.91 months;
p
= 0.79). Complication rates were also similar in both groups, with one infection in the allograft group and two in the autograft group, two delayed unions in the allograft group, and three in the autograft group. The operative time differed by 11 min between the groups, being lower in the allograft group (Allograft: 65.4 ± 15.1 min vs. Autograft: 76.3 ± 15.2 min;
p
= 0.02).
Conclusion
Iliac crest allografts can be safely and effectively used in medial opening wedge high tibial osteotomy as it promotes the same rates of bone union as those achieved by autologous grafts, with the benefits of a shorter operative time.
Trial Registration Number
U1111-1280-0637 1 December 2022, retrospectively registered.
Journal Article
Injectable platelet-rich fibrin with demineralized freeze-dried bone allograft compared to demineralized freeze-dried bone allograft in intrabony defects of patients with stage-III periodontitis: a randomized controlled clinical trial
by
Alshoiby, Mashaal Mohammed
,
Fawzy El-Sayed, Karim Mohamed
,
Elbattawy, Weam
in
Allografts
,
Bone grafts
,
Clinical trials
2023
AimThe current randomized controlled clinical trial assessed the effect of injectable platelet-rich fibrin (I-PRF) combined with demineralized freeze-dried bone allograft (DFDBA) compared to DFDBA alone in the management of intrabony defects of stage-III periodontitis patients.MethodologyFollowing sample size calculation, twenty stage-III periodontitis patients with ≥ 5 mm clinical attachment level (CAL)-loss and ≥ 3 mm intrabony defects were randomized into test (I-PRF + DFDBA; n = 10) and control (DFDBA; n = 10) groups. CAL (primary outcome), periodontal probing depth (PPD), gingival recession depth (GRD), full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), radiographic linear defect depth (RLDD), and bone fill (secondary outcomes) were examined at baseline, 3, 6, and 9 months post-surgically.ResultsI-PRF + DFDBA and DFDBA independently demonstrated significant intragroup CAL-gain, PPD-, and RLDD-reduction at 3, 6, and 9 months (p < 0.05), with no significant intergroup differences observed (p > 0.05). CAL-gain (mean ± SD) of 2.40 ± 0.70 mm and 2.50 ± 0.85 mm and PPD-reduction of 3.50 ± 1.18 mm and 2.80 ± 0.42 mm were demonstrated for I-PRF + DFDBA and DFDBA at 9 months respectively. Both groups showed significant intragroup RLDD improvement, with a RLDD of 3.58 ± 0.66 mm and 3.89 ± 1.57 mm for I-PRF + DFDBA and DFDBA at 9 months respectively. Stepwise linear regression analysis revealed that baseline RLDD and bone fill at 9 months were significant predictors of CAL (p < 0.05).ConclusionWithin the present study’s limitations, DFDBA with or without I-PRF resulted in significant improvement in clinical and radiographic periodontal parameters in the surgical treatment of periodontal intrabony defects of stage-III periodontitis patients. Addition of I-PRF to DFDBA does not appear to significantly enhance the DFDBA’s reparative/regenerative outcomes.Clinical relevanceWithin the current study’s limitations, routinely adding I-PRF to DFDBA cannot be recommended to significantly improve DFDBA’s treatment outcomes in intrabony defects.
Journal Article
Comparative evaluation of autologous dental bone powder and deproteinized bovine bone mineral allografts for oral implant bone deficits
2024
Objective
To compare the effectiveness of autologous dental bone powder grafts with deproteinized bovine bone mineral (DBBM) allografts in oral implant bone deficiency.
Methods
Between January 2021 and January 2023, we enrolled 120 patients with inadequate bone for oral implantation, dividing them into an experimental group and a control group (60 each). The experimental group received autologous dental bone powder grafts, while the control group received DBBM allografts. Wound healing was assessed using the early healing index (EHI) with 5 days of closure as the baseline timeline, as Grade I: full closure without a fibrin line, Grade II: closure with a fibrin line, and Grade III: closure with fibrin covering the incision. Additional outcomes included buccal and palatal alveolar bone height, alveolar bone width at 3 (W1), 7 (W2), and 11 mm (W3) below the top of the alveolar ridge, and bone density measured before and 3 months after tooth extraction. The altered shape of the alveolar bone at the extraction site was assessed at 3- and 6-months post-extraction. Implant success rate was also evaluated at 15 days and 1 month after implantation. Comparisons were made using independent t-tests, paired t-tests, χ² tests, and Z tests, as appropriate.
Results
The experimental group had a lower wound healing time and a greater prevalence of EHI categorization class I compared to the control group (
P
< 0.05). Three months after tooth extraction, there was no statistically significant difference in buccal and palatal alveolar bone heights between the experimental group and the pre-treatment measurements (
P
> 0.05). However, the control group showed a decrease in buccal and palatal alveolar bone heights compared to the pre-treatment period, while the experimental group had greater bone heights than the control group (
P
< 0.05). Three months after extraction, the widths of W1, W2, and W3 decreased in both groups. However, the experimental group maintained greater widths compared to the control group (
P
< 0.05). At 3 months post-extraction, both groups showed an increase in alveolar bone density at the extraction site. Notably, the experimental group had a higher bone density compared to the control group as well as new bone contour score of the alveolar bone at the extraction site (
P
< 0.05). However, at 6 months after extraction, there was no statistically significant difference in the new bone contour score of the alveolar bone at the extraction site between the two groups (
P
> 0.05). There was no significant difference in the implant success rate between the two groups. (
P
> 0.05).
Conclusions
Autologous dental bone powder grafting promotes initial alveolar bone regeneration, enhances wound healing, and increases new bone density, providing favorable surgical conditions for dental implants. However, by 6 months, there was no significant difference in bone contour compared to DBBM allografts, indicating similar long-term clinical outcomes for both materials.
Journal Article
The impact of root end filling material type and the application of bone graft on healing of periapical tissues after endodontic microsurgery (a clinical randomized controlled trial)
by
Khallaf, Mustafa
,
Haddadeen, Haseeb
,
Salah, Hesham Mohamed
in
692/308/409
,
692/699/3017
,
Adult
2024
To evaluate the effect of combining different bioactive root-end filling materials with composite bone graft (xenogeneic mixed with autogenous bone fragments) on the healing process of periapical tissues after endodontic micro-surgery procedure. In this triple-blinded clinical trial, 56 patients were divided into 2 main groups (28 each) according to the root-end filling material and 2 subgroups according to the presence or absence of the composite bone graft material. Group I: MTA root-end filling (n = 28) in which there are Sub-group A: without bone graft (n = 14) and Sub-group B: with composite bone graft (n = 14). Group II: TotalFill root-end filling (n = 28) in which there are Sub-group A: without bone graft (n = 14) and Sub-group B: with composite bone graft (n = 14). Healthy patients whose ages range from 20 to 50 years with small-to-medium size radiolucency in CBCT related to single-rooted maxillary teeth were included in this study. Patients were assigned a number starting from 1 to 56 and were randomly allocated to four test groups (2 main groups and 2 sub-groups) following simple randomization procedure guidelines described by IBM SPSS V23 (IBM USA) statistical analysis software. This trial was triple-blind where the patient, the outcome assessors, and the main operator were blinded to the applied intervention. Every patient was evaluated clinically and by CBCT at two main observation periods: presurgical and 12-month post-operative. They were also examined and evaluated clinically and radiographically through periapical x-rays after one week, three, and six months. Statistical analysis was performed with IBM SPSS Statistics for Windows Version 23.0. Armonk, NY: IBM Corp. Of the 56 patients enrolled in the study, 49 patients were available for the final analysis. All groups showed no statistically significant differences with regard to healing or success rates at the 12-month follow-up mark. No adverse effects were encountered. Results showed that high success rates were achieved using MTA and TotalFill in the healing of periapical lesions after endodontic surgery. The addition of bone graft in small-to-medium size lesions did not affect the success rate of endodontic surgeries.
Journal Article
A Histologic and Histomorphometric Evaluation of an Allograft, Xenograft, and Alloplast Graft for Alveolar Ridge Preservation in Humans: A Randomized Controlled Clinical Trial
by
Gkisakis, Ioannis G.
,
Tovar, Nick
,
Coelho, Paulo G.
in
Allografts - pathology
,
Allografts - transplantation
,
Alveolar Ridge Augmentation - methods
2022
The aim of this study was to clinically evaluate the guided bone regeneration (GBR) potential of allograft, xenograft, and alloplastic materials in combination with resorbable membranes in extraction sockets. The qualitative and quantitative assessments of this prospective study were accomplished through histologic and histomorphometric analysis. Three experimental groups and 1 control group for comparison (n = 8) received either an allograft (human cancellous bone, freeze dried, Deutsches Institut für Zell und Gewebeersatz, Berlin, Germany), xenograft (BioOss, Geistlich Pharma AG, Wolhusen, Switzerland), or alloplast (biphasic calcium sulphate, Bondbone, MIS Implants Technologies Ltd., Charlotte, NC). The negative control group received no regenerative material. Tissue samples were then qualitatively and quantitatively evaluated as a function of percentage of new vital bone, graft particles content, soft tissue, and bone marrow over time. All 3 study groups presented bone volume suitable for the successful placement of a dental implant. The xenograft group yielded significantly less amount of vital bone compared with the allograft and alloplast groups. When comparing the percentage of residual graft particles, there was significantly greater amounts associated with the xenograft group in contrast to the allograft and alloplast groups. Similarly, a significantly increased amount of soft tissue percentage was observed within the xenograft group relative to all other groups. No significant differences were observed in the percentage of residual graft particles between the allograft and alloplast groups. There were also no significant differences detected in vital bone percentage between the allograft, alloplast, and control groups. When evaluating the bone marrow percentage, the only significant difference detected was between the xenograft and alloplast materials. Overall, no complications (ie, fever, malaise, purulence or fistula) were observed during the entirety of clinical trial among all patients. The greatest GBR potential was associated with the allograft material because of the greater degree of vital bone and the lowest percentage of residual graft particles. All studied bone substitute materials resulted in bone apposition for efficient use in alveolar ridge preservation procedures.
Journal Article
Prospective comparison of two different surgical technique in the treatment of deep osteochondral lesions of the talus: mosaicplasty versus all-arthroscopic technique with scaffold and autograft bone taken from the tibial plafond
by
Armangil, Mehmet
,
Özyıldıran, Mustafa
,
Özbek, Emre Anıl
in
Adult
,
Arthroscopy - methods
,
Autografts
2024
Introduction
There are various surgical techniques applied for the treatment of osteochondral lesions of the talus (OLT). The mosaicplasty technique is one of the most commonly used methods for deep lesions. The all-arthroscopic technique with scaffold and autograft bone taken from the tibial plafond is a novel method as an alternative to the mosaicplasty. This study aims to compare the clinical and radiological results of these two different surgical techniques in the treatment of deep OLT.
Materials and methods
From September 2019 to July 2021, 30 patients with deep osteochondral lesions of the talus were randomly divided into two groups for either mosaicplasty or the all-arthroscopic technique, and they were evaluated prospectively. American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale and visual analog scale (VAS) scores were evaluated within and between groups preoperatively and postoperatively. Radiological assessments were performed at 6th and 12th month postoperatively according to the magnetic resonance observation of cartilage repair tissue (MOCART) scale.
Results
Mosaicplasty was applied to 15 patients, and all-arthroscopic technique was applied to 15 patients. 14 of the patients were female and 16 were male; the mean age was 38.1. Within-group evaluations revealed significant improvements in AOFAS and VAS scores at postoperative 6th and 12th months (p < 0.05). There was no significant difference between the treatment groups in comparison of clinical scores at any time period. There was no significant difference between the two methods according to the total MOCART scores (p > 0.05). However, the all-arthroscopic technique was more successful in terms of “border integration” and “repair tissue structure” (p < 0.05). Age, body mass index (BMI) and lesion surface area were not correlated with clinical scores.
Conclusions
In terms of clinical and radiological scores, similar results were obtained in the treatment groups. Both surgical techniques were found to be effective in the treatment of deep OLT.
Journal Article
Arthroscopic versus open cancellous bone grafting for scaphoid delayed/nonunion in adults (SCOPE-OUT): study protocol for a randomized clinical trial
by
Gvozdenovic, Robert
,
Kjaer, Morten
,
Rasmussen, Jeppe Vejlgaard
in
Adult
,
Adults
,
Arthroscopic
2023
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.
Journal Article
Osteogenic Potential of Autologous Dentin Graft Compared with Bovine Xenograft Mixed with Autologous Bone in the Esthetic Zone: Radiographic, Histologic and Immunohistochemical Evaluation
by
Oguić, Matko
,
Vidaković, Bruno
,
Čandrlić, Marija
in
Alveolar Bone Loss
,
Alveolar Ridge Augmentation - methods
,
Animals
2023
This prospective, randomized, controlled clinical trial reports clinical, radiographic, histologic and immunohistochemical results of autologous dentin graft (ADG) and its comparison with a mixture of bovine xenograft with autologous bone (BX+AB). After tooth extraction in the esthetic zone of maxilla, the alveolar ridge of 20 patients in the test group was augmented with ADG, while 17 patients in the control group received the combination of BX+AB. Cone beam computed tomography (CBCT) was performed before tooth extraction and after 4 months when a total of 22 bone biopsies were harvested and subjected to histological and immunohistochemical analysis. Radiological analysis showed comparable results of bone dimension loss in both groups. Quantitative histologic analysis showed comparable results with no statistically significant differences between the groups. Immunohistochemical staining with TNF-α and BMP-4 antibodies revealed immunopositivity in both groups. A statistically significant difference between the groups was found in the intensity of TNF-α in the area of newly formed bone (p = 0.0003) and around remaining biomaterial particles (p = 0.0027), and in the intensity of BMP-4 in the area around biomaterial particles (p = 0.0001). Overall, ADG showed biocompatibility and achieved successful bone regeneration in the esthetic zone of the maxilla similar to BX+AB.
Journal Article