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Stem cell-based therapy for prevention of delayed fracture union: a randomized and prospective preliminary study.

ABSTRACT: Distal tibial fractures tend towards delayed- or nonunion. The purpose of this study was to evaluate the safety and efficacy of early minimally invasive intervention (MII) in the treatment of these fractures. A total 24 consecutive patients who underwent operative treatment for distal tibial fractures were randomized into a control and an intervention group. MII entailed aspirating iliac crest bone marrow and peripheral blood, yielding mesenchymal stem cells (MSCs) and platelet-rich plasma (PRP) respectively, that were mixed with demineralized bone matrix (DBM) and injected under fluoroscopic control into the fracture site. No complications occurred in either group. The median time to union was 1.5 months in the MII group and 3 months in the control group. MII was found to be a safe and efficient procedure.

SUBMITTER: Liebergall M

PROVIDER: S-EPMC3739419 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

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Stem cell-based therapy for prevention of delayed fracture union: a randomized and prospective preliminary study.

Liebergall Meir M Schroeder Josh J Mosheiff Rami R Gazit Zulma Z Yoram Zilberman Z Rasooly Linda L Daskal Anat A Khoury Amal A Weil Yoram Y Beyth Shaul S

Molecular therapy : the journal of the American Society of Gene Therapy 20130604 8

Distal tibial fractures tend towards delayed- or nonunion. The purpose of this study was to evaluate the safety and efficacy of early minimally invasive intervention (MII) in the treatment of these fractures. A total 24 consecutive patients who underwent operative treatment for distal tibial fractures were randomized into a control and an intervention group. MII entailed aspirating iliac crest bone marrow and peripheral blood, yielding mesenchymal stem cells (MSCs) and platelet-rich plasma (PRP) ...[more]

PMID: 23732992

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Project description:BackgroundHyperbaric oxygen therapy (HBOT) consists of intermittently administering 100% oxygen at pressures greater than one atmosphere absolute (ATA) in a pressure vessel. This technology has been used to treat a variety of diseases and has been described as helping patients who have delayed healing or established non-union of bony fractures. This is an update of a Cochrane Review first published in 2005, and previously updated in 2008.ObjectivesThe aim of this review is to assess the evidence for the benefit of hyperbaric oxygen treatment (HBOT) for the treatment of delayed bony healing and established non-union of bony fractures.Search methodsWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (July 2012), the Cochrane Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 7), MEDLINE (1946 to July Week 1 2012), EMBASE (1974 to 2012 July 16), CINAHL (1937 to 17 July 2012), the Database of Randomised Controlled Trials in Hyperbaric Medicine (accessed July 2012), the WHO International Clinical Trials Registry Platform (17 July 2012) and reference lists of articles.Selection criteriaWe aimed to include all randomised controlled trials comparing the clinical effects of HBOT with no HBOT (no treatment or sham) for healing of bony fractures and fracture non-unions.Data collection and analysisTwo review authors independently screened electronic search results, and all three authors independently performed study selection. We planned independent data collection and risk of bias assessment by two authors using standardised forms.Main resultsNo trials met the inclusion criteria. In this update, we identified three ongoing randomised controlled trials. Among the eight excluded studies were three randomised trials comparing HBOT with no treatment that included patients with fractures. One of these trials had been abandoned and the other two did not report on fracture healing outcomes.Authors' conclusionsThis systematic review failed to locate any relevant clinical evidence to support or refute the effectiveness of HBOT for the management of delayed union or established non-union of bony fractures. Good quality clinical trials are needed to define the role, if any, of HBOT in the treatment of these injuries. There are three randomised controlled trials underway and we anticipate these will help provide some relevant clinical evidence to address this issue in the future.

Project description:AimsPatients who present with fragility fractures are consistently under-evaluated and under-treated for underlying osteoporosis. This point-of-care represents a lost opportunity to prevent future fractures. This 2-arm study evaluated the success by an orthopaedic department in osteoporosis evaluation and initiating treatment.MethodsPatients over the age of 50 years with a fragility fracture of the hip were candidates for inclusion. Exclusion criteria included end-of-life care and moderate or severe dementia. Patients were prospectively randomized into 1 of 2 groups. The Letter group received a letter at the time of discharge encouraging their primary care physician to start medication for osteoporosis (Letter group). The intervention group had 4 interventions including printed information, a DEXA scan, a specific treatment recommendation, and monthly phone calls for 4 months (Intervention group). The primary outcome measure was whether the patient was on recommended treatment at 4 months from the fracture.ResultsThere were 200 patients in the study, 100 in the Letter, and 100 in the Intervention group. Sixteen patients were removed from the study since they either died (9) within 4 months of their fracture, were transferred for end-of-life care (7), and 4 dropped out. This left 180 patients for analysis. The Letter group had only 6 patients (6.2%) on recommended treatment compared with the Intervention group with 64 patients (77.1%). This was statistically significant (P < 0.0001).ConclusionOsteoporosis is a worldwide epidemic. Internationally, only about 20% of patients after a hip fracture are treated for their underlying weak bone. The most effective systems use a fracture liaison service (FLS) model. We present a 4-part intervention program that uses an FLS coordinator within the orthopaedic department. We encourage orthopaedic programs to adopt this or other models with the goal of taking the first step toward responsibility for bone health.An FLS program within an orthopaedic department can successfully initiate treatment for underlying osteoporosis.

Project description:BackgroundInterphalangeal coalition is characterized by fusion of interphalangeal joint between the middle and distal phalanges. Interphalangeal coalition fractures often result in delayed union or nonunion. The purpose of this study was to evaluate the results of focused extracorporeal shock wave therapy (ESWT) for painful delayed union or nonunion of fractures of the interphalangeal coalition.MethodsThe study group consisted of 9 patients (9 feet) diagnosed with painful delayed union or nonunion due to persistent pain and no tendency toward bony union for at least 3 months after the interphalangeal coalition fracture on plain radiographs between 2021 and 2023 were included. The mean age was 51.3 years (23-64). Focused ESWT was performed in all patients. The mean time from the date of injury to the start of ESWT was 16.1 weeks (12-15). ESWT was performed every 2 weeks, with each session consisting of 3000 impulses (0.15-0.25 mJ/mm2). Plain radiographs were used to confirm bone union, and visual analog scale (VAS) scores were used for pain assessment.ResultsComplete bony union was documented in all 9 patients. The application of focused ESWT was performed a mean of 2.7 times (2-4), and the mean duration from the initiation of treatment to the confirmation of bony union was 7.4 weeks (3.6-12.7). In all cases, the symptoms of swelling and pain were alleviated. The VAS scores exhibited significant improvement, with the mean VAS score decreasing from 3.8 (2-6) before ESWT to 0 after the achievement of union (P < .001).ConclusionIn this small cohort, all patients with painful delayed union or nonunion of fractures at the interphalangeal coalitions achieved complete bony fusion after focused ESWT. Moreover, bony union was observed within 2 months of ESWT initiation. These findings suggest that focused ESWT may be a valuable treatment option for painful delayed union or nonunion of interphalangeal coalition fractures.Level of evidenceLevel IV, case series.

Project description:BACKGROUND: Despite the known multi-factorial nature of atrophic fracture non-unions, a possible genetic predisposition for the development of this complication after long bone fractures remains unknown. This pilot study aimed to address this issue by performing a preliminary SNP analysis of specific genes known to regulate fracture healing. METHODS: A total of fifteen SNPs within four genes of the Bone Morphogenetic Protein (BMP) pathway (BMP-2, BMP-7, NOGGIN and SMAD6) were examined, in 109 randomly selected patients with long bone fractures as a result of motor vehicle accident, fall or direct blow. There were sixty-two patients with atrophic non-union and forty-seven patients (54 fractures) with uneventful fracture union. Overall SNPs frequencies were computed with respect to patient's age, gender, smoking habits, fracture-associated parameters and the use of nonsteroidal anti-inflammatory drugs (NSAIDs), and tested for their association to the impaired bone healing process, using binary logistic regression (STATA 11.1; StataCorp, Texas USA). RESULTS: Statistical analysis revealed age to be an important covariate in the development of atrophic non-union (p = 0.01, OR 1.05 [per year]), and two specific genotypes (G/G genotype of the rs1372857 SNP, located on NOGGIN and T/T genotype of the rs2053423 SNP, located on SMAD6) to be associated with a greater risk of fracture non-union (p = 0.02, OR 4.56 and p = 0.04, OR 10.27, respectively, after adjustment for age). CONCLUSIONS: This is the first clinical study to investigate the potential existence of genetic susceptibility to fracture non-union. Even though no concrete conclusions can be obtained from this pilot study, our results indicate the existence of a potential genetically predetermined impairment within the BMP signalling cascade, initiated after a fracture and when combined with other risk factors could synergistically increase the susceptibility of a patient to develop non-union. Further research is desirable in order to clarify the genetic component and its role and interaction with other risk factors in the development of atrophic long bone non-union, as simple genetic testing may contribute to the early identification of patients at risk in the future and the on-time intervention at the biologic aspects of bone healing.

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Stem cell-based therapy for prevention of delayed fracture union: a randomized and prospective preliminary study.

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Stem cell-based therapy for prevention of delayed fracture union: a randomized and prospective preliminary study.

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