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Comparison of Puddu osteotomy with or without autologous bone grafting: a prospective clinical trial.

ABSTRACT: OBJECTIVES:To test the hypothesis that autologous iliac bone grafts do not enhance clinical results and do not decrease complication rates in patients undergoing medial opening-wedge high tibial osteotomy. METHODS:Forty patients allocated in a randomized, two-armed, double-blinded clinical trial were evaluated between 2007 and 2010. One group received bone graft, and the other group was left without filling the osteotomy defect. The primary outcome was the Knee Society Score. Radiographic measurement of the frontal anatomical femoral-tibial angle and the progression of osteoarthritis according to the modified Ahlback classification were used as secondary outcomes. RESULTS:There was no difference in KSS scale between the graft group (64.4 ± 21.8) and the graftless group (61.6 ± 17.3; p = 0.309). There was no difference of angle between the femur and tibia in the frontal plane between the groups (graft = 184 ± 4.6 degrees, graftless = 183.4 ± 5.1 degrees; p = 1.0), indicating that there is no loss of correction due to the lack of the graft. There was significant aggravation of osteoarthritis in a greater number of patients in a graft group (p = 0.005). CONCLUSION:Autologous iliac bone graft does not improve clinical outcomes in medium and long-term follow-up of medial opening-wedge high tibial osteotomy fixed with a first generation Puddu plate in the conditions of this study.

SUBMITTER: Passarelli MC

PROVIDER: S-EPMC5643891 | biostudies-literature | 2017 Sep-Oct

REPOSITORIES: biostudies-literature

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Comparison of Puddu osteotomy with or without autologous bone grafting: a prospective clinical trial.

Passarelli Marcus Ceregatti MC Filho José Roberto Tonelli JRT Brizzi Felipe Augusto Mendes FAM Campos Gustavo Constantino de GC Zorzi Alessandro Rozim AR Miranda João Batista de JB

Revista brasileira de ortopedia 20170914 5

<h4>Objectives</h4>To test the hypothesis that autologous iliac bone grafts do not enhance clinical results and do not decrease complication rates in patients undergoing medial opening-wedge high tibial osteotomy.<h4>Methods</h4>Forty patients allocated in a randomized, two-armed, double-blinded clinical trial were evaluated between 2007 and 2010. One group received bone graft, and the other group was left without filling the osteotomy defect. The primary outcome was the Knee Society Score. Radi ...[more]

PMID: 29062820

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Project description:BackgroundThe objective was to assess whether intraoral bone augmentation procedures have an impact on the patient's plasma levels of circulating nucleic acids, exosomes, miRNA levels and caspase activities. The null hypothesis was tested, that no significant differences between the two groups will be found.MethodsIn this prospective randomized controlled clinical trial 35 systemically healthy non-smoking participants were randomly allocated using sealed envelopes by a blinded clinician not involved in the clinical setting. Plasma samples were collected preoperatively and 3 times postoperatively (immediately, 5 weeks and 4 months postoperatively). The test group consisted of twenty-five patients who received allogeneic bone grafting material and the control group of ten patients who received autologous bone grafts. Levels of cell-free DNA (cfDNA) and microRNAs (miR-21, miR-27a, miR-218) were quantified by real-time PCR, caspase activities and exosome concentrations were determined by ELISA.ResultsStatistical evaluation reveled a significantly higher exosome level before surgery (p = 0.013) and the first postsurgical sample (p = 0.017) in the control group compared to the test group. The levels of miR-27a and miR-218 significantly differed between the plasma samples before surgery and after surgery in both groups. The levels of miR-21 only significantly differed between the pre- and postsurgical plasma samples in the test group, but not in the control group. All patients completed the study, no adverse events were recorded.ConclusionsOur data show the diagnostic potential of the plasma levels of miR-27a, miR-218 and miR-21 in detecting changes in bone metabolism after alveolar bone augmentation. Our very promising results indicate that there might be a high diagnostic potential in evaluating the plasma levels of the before mentioned miRNAs in order to detect bone resorption activities before they become clinically relevant. Trial registration Ethical commission of the Ärztekammer Hamburg, Germany (PV5211) on 11/03/2016 as well as by the German Registry of Clinical Studies (DRKS 00,013,010) on 30/07/2018 ( http://apps.who.int/trialsearch/ ).

Project description:Background contextPseudarthrosis following spinal fusion remains problematic despite modern surgical and grafting techniques. In surgical spinal fusion, new bone forms via intramembranous and endochondral ossification, with endochondral ossification occurring in the hypoxic zones of the fusion bed. During bone development and fracture healing, the key cellular mediator of endochondral ossification is the hypertrophic chondrocyte given its ability to function in hypoxia and induce neovascularization and ossification. We therefore hypothesize that hypertrophic chondrocytes may be an effective bone graft alternative.PurposeSpinal fusion procedures have increased substantially; yet 5% to 35% of all spinal fusions may result in pseudoarthrosis. Pseudoarthrosis may occur because of implant failure, infection, or biological failure, among other reasons. Advances in surgical techniques and bone grafting have improved fusion; however pseudarthrosis rates remain unacceptably high. Thus, the goal of this study is to investigate hypertrophic chondrocytes as a potential biological graft alternative.MethodsUsing a validated murine fracture model, hypertrophic chondrocytes were harvested from fracture calluses and transplanted into the posterolateral spines of identical mice. New bone formation was assessed by X-ray, microcomputed tomography (μCT), and in vivo fluorescent imaging. Results were compared against a standard iliac crest bone graft and a sham surgery control group. Funding for this work was provided by the Department of Orthopaedics and Rehabilitation, the OREF (Grant #16-150), and The Caitlin Lovejoy Fund.ResultsRadiography, μCT, and in vivo fluorescent imaging demonstrated that hypertrophic chondrocytes promoted bone formation at rates equivalent to iliac crest autograft. Additionally, μCT analysis demonstrated similar fusion rates in a subset of mice from the iliac crest and hypertrophic chondrocyte groups.ConclusionsThis proof-of-concept study indicates that hypertrophic chondrocytes can promote bone formation comparable to iliac crest bone graft. These findings provide the foundation for future studies to investigate the potential therapeutic use of hypertrophic chondrocytes in spinal fusion.

Project description:Bone morphogenetic proteins (BMPs) are potent osteogenic proteins that induce new bone formation in vivo. However, their effect on bone healing in the trabecular bone surfaces remains challenging. We evaluated the safety and efficacy of recombinant human BMP6 (rhBMP6) applied within an autologous blood coagulum (ABC) in a surgically created wedge defect of the proximal tibia in patients undergoing high tibial osteotomy (HTO) for varus deformity and medial osteoarthritis of the knee. We enrolled 20 HTO patients in a randomized, placebo-controlled, double-blinded phase I/II clinical trial. RhBMP6/ABC (1.0 mg/10 mL ABC prepared from peripheral blood) or placebo (10 mL ABC containing excipients) was administered into the tibial wedge defects. Patients were followed for 0 to 24 months by clinical examination (safety) and computed tomography (CT) and serial radiographic analyses (efficacy). The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks after implantation. During the 24 months of follow-up, there were no serious adverse reactions recorded. The CT scans from defects of patients treated with rhBMP6/ABC showed an accelerated bone healing compared with placebo at 9 weeks (47.8 ± 24.1 versus 22.2 ± 12.3 mg/cm3 ; p = 0.008) and at 14 weeks (89.7 ± 29.1 versus 53.6 ± 21.9 mg/cm3 ; p = 0.006) follow-up. Radiographic analyses at weeks 6 and 24 and months 12 and 24 suggested the advanced bone formation and remodeling in rhBMP6/ABC-treated patients. In conclusion, we show that rhBMP6/ABC at a dose of 100 μg/mL accelerated bone healing in patients undergoing HTO without serious adverse events and with a good tolerability compared with placebo alone. Overall, for the first time, a BMP-based osteogenic implant was examined against a placebo for bone healing efficacy in the trabecular bone surface, using an objective bone mineral density measurement system. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.

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Comparison of Puddu osteotomy with or without autologous bone grafting: a prospective clinical trial.

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Comparison of Puddu osteotomy with or without autologous bone grafting: a prospective clinical trial.

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