Dataset Information

Treatment of Pre-Collapse Stages of Osteonecrosis of the Femoral Head: a Systematic Review of Randomized Control Trials.

ABSTRACT:

Background

Treatment for osteonecrosis of the femoral head (ONFH) remains controversial. Current reviews include low-level evidence studies evaluating the treatment of both pre-collapse and collapse stages of the disease.

Questions/purposes

The purpose of the current study is to systematically review the literature evaluating core decompression (CD) with bone marrow mesenchymal cells (BMMCs), CD alone, and bisphosphonate treatment in pre-collapse ONFH by focusing just on randomized clinical trials (RCTs) reporting functional and radiologic outcomes. We aim to determine if the literature provides evidence supporting any single approach.

Methods

Using PubMed and EMBASE databases, we reviewed the clinical evidence of treatments for pre-collapse ONFH following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Twelve RCTs met the inclusion criteria.

Results

Results showed that CD with BMMCs has lower risk of femoral head collapse when compared to the CD alone excluding hips lost to follow-up (relative risk (RR) [95% CI]:0.25 [0.11, 0.60]; p?=?0.002) and when assumed that hips lost to follow-up experienced collapse (RR [95% CI]: 0.11 [0.03, 0.47]; p?=?0.003). Neither CD nor bisphosphonate treatments showed lower risk to femoral head collapse when compared to control treatments (p?=?0.46 and 0.31, respectively).

Conclusion

Current literature shows that there is a lower risk of femoral head collapse in patients with ONFH treated with CD combined with BMMCs when compared to CD alone; however, there is no robust evidence to determine the effect on functional outcomes. More RCTs assessing new combination therapies and using standardized outcome measures are required.

SUBMITTER: Villa JC

PROVIDER: S-EPMC5026659 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Publications

Treatment of Pre-Collapse Stages of Osteonecrosis of the Femoral Head: a Systematic Review of Randomized Control Trials.

Villa Jordan C JC Husain Solomon S van der List Jelle P JP Gianakos Arianna A Lane Joseph M JM

HSS journal : the musculoskeletal journal of Hospital for Special Surgery 20160608 3

<h4>Background</h4>Treatment for osteonecrosis of the femoral head (ONFH) remains controversial. Current reviews include low-level evidence studies evaluating the treatment of both pre-collapse and collapse stages of the disease.<h4>Questions/purposes</h4>The purpose of the current study is to systematically review the literature evaluating core decompression (CD) with bone marrow mesenchymal cells (BMMCs), CD alone, and bisphosphonate treatment in pre-collapse ONFH by focusing just on randomize ...[more]

PMID: 27703421

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Project description:Femoral head collapse is a key reference point for determining a treatment regimen of femoral head osteonecrosis. However, there are no effective preventive measures and the efficacy of hip-preserving surgery is unsatisfactory due to the unclear mechanism of collapse. This study aimed to identify and validate miRNAs differentially expressed in collapse and non-collapse areas of the osteonecrotic femoral head, and to predict the target genes and pathways of these miRNAs.Nine samples passed the quality control test. A total of 2085 differentially expressed miRNAs were detected, among which 433 miRNAs showed differential expression in the T1 group compared to the W1 group; 344 miRNAs showed differential expression in the T2 group compared to the W2 group; 107 miRNAs showed differential expression in the T3 group compared to the W3 group. After combining data from all three patients, 10 miRNAs showed differential expression in the collapse area (T1+T2+T3) compared to the non-collapse area (W1+W2+W3). Compared to the normal area, has-miR-195-5p showed the most significant downregulation. Expression results from RT-PCR revealed that the expression of hsa-miR-195-5p in the collapse area (T1+T2+T3) was significantly lower than that in the non-collapse area (W1+W2+W3) and normal area (Z1+Z2+Z3). 157 genes were perdicted as the target gene of hsa-miR-195-5p.Femoral heads of three patients (2 males and 1 female) treated by total hip arthroplasty surgery for steroid-induced femoral head osteonecrosis were selected based on inclusion and exclusion criteria. Bone tissue samples were obtained from the collapse area (T), non-collapse area (W), and normal area (Z) according to the anatomical structure of osteonecrotic femoral heads. Total RNA was extracted from the samples and the microarray chip was scanned. miRNAs showing differential expressions of more than 1.5-fold were selected and was validated by RT-PCR. TargetScan, mirBase and miRanda bioinformatics software was used to predict target genes and identify possible pathways involving these genes.miR-195-5p showed the most significant difference in the collapse area of osteonecrotic femoral heads, suggesting that collapse may be related to the downregulation of miR-195-5p.

Project description:ObjectivesAutologous peripheral blood stem cell (auto-PBSC) transplantation is an effective therapeutic for the osteonecrosis of the femoral head (ONFH) but without prognosis estimation. This study mainly aimed to (1) determine whether auto-PBSC transplantation is a promising option, (2) assess the risk of hip-preservation failure, (3) achieve a predictive model of femoral head survival after the intervention, and (4) eventually identify clinical indications for auto-PBSC transplantation in future.MethodsAfter reviewing the in-patient database of the First Affiliated Hospital of Zhejiang Chinese Medicine University from June 2012 to June 2014, 37 eligible patients with Association Research Circulation Osseous stage I or II ONFH who were receiving intra-arterial infusion of auto-PBSCs were recruited. A case form was designed to retrieve relevant data. Hip-preservation failure was defined as the endpoint. All participants were stratified by the categorical risk of collapse, which was statistically tested through log-rank analysis. All significant factors were evaluated using Cox proportional hazards regression model, and a predictive nomogram plot was generated.ResultsIn total, 47 hips were followed up for 53.96 ± 21.09 months; the median survival time was 60.18 months. Among the predictors, body mass index (BMI; P = 0.0015) and Harris hip score (HHS; P < 0.0001) independently affected femoral head survival. Patients with BMI ≥ 24 kg/m2 exhibited a 2.58 times higher risk of hip-preservation failure [95% confidence interval (CI), 1.32-5.45] than those with BMI < 24 kg/m2, whereas those with HHS ≥ 70 exhibited a 0.19 times lower risk (95% CI, 0.09-0.38) than those with HHS < 70. Hazard ratios associated with age (P = 0.042), BMI (P = 0.012), HHS (P = 0.022), and necrotic volume (P = 0.000) were 1.038 (95% CI, 1.001-1.075), 1.379 (95% CI, 1.072-1.773), 0.961 (95% CI, 0.928-0.994), and 1.258 (95% CI, 1.120-1.412), respectively. A nomogram plot (score test P = 0.000; C-index = 0.8863) was available for the orthopedic doctor to predict hip survival probability.ConclusionsThe results suggest that intra-arterial infusion of auto-PBSCs prolongs femoral head survival. Age, BMI, HHS, and necrotic volume can influence the efficacy of this intervention. This study was approved by ethics committee of the trial center, number 2019-KL-075-01.

Project description:BackgroundIn patients with nontraumatic osteonecrosis of the femoral head (ONFH), implantation of bone marrow aspirate concentrate (BMAC) could delay the progression of osteonecrosis and improve symptoms in pre-fracture ONFH. However, the BMAC content, especially in osteoblastic stem cells, could have an important individual variability. An autologous osteoblastic cell product could improve the effect of such cell-based therapy.Questions/purposes(1) Does autologous osteoblastic cell therapy decrease the likelihood of progression to subchondral fracture with or without early collapse corresponding to Association Research Circulation Osseous (ARCO) classification Stage III or higher, and provide a clinically important pain improvement compared with BMAC treatment alone? (2) Were patients treated with osteoblastic cell therapy less likely to undergo subsequent THA? (3) What proportion of patients in the treatment and control groups experienced adverse events after surgery?MethodsBetween 2004 and 2011, we treated 279 patients for Stage I to II hip osteonecrosis (ON) with surgery. During that time, our general indications for surgery in this setting included non-fracture ON lesions. To be eligible for this randomized, single-blind trial, patients needed to have an ONFH Stage I or II; we excluded those with traumatic ONFH, hemoglobinopathies and positive serology for hepatitis B, C or HIV. Of those treated surgically for this diagnosis during the study period, 24% (67) agreed to participate in this randomized trial. Hips with pre-fracture ONFH were randomly treated with a core decompression procedure associated with either implantation of a BMAC (BMAC group; n = 26) or osteoblastic cell (osteoblastic cell group; n = 30). The groups were not different in terms of clinical and imaging characteristics. The primary study outcome was treatment response, defined as the absence of progression to subchondral fracture stage (ARCO stage III or higher) plus a clinically important pain improvement defined as 1 cm on a 10-cm VAS. The secondary endpoint of interest was the frequency in each group of subsequent THA and the frequency of adverse events. The follow-up duration was 36 months. We used an as-treated analysis (rather than intention-to-treat) for our efficacy endpoint, and an intention-to-treat analysis for adverse events. Overall, 26 of 26 patients in the BMAC group and 27 of 30 in the osteoblastic cell group completed the trial.ResultsAt 36 months, no clinically important differences were found in any study endpoint. There was no difference in the proportion of patients who had progressed to fracture (ARCO stage III or higher; 46% of the BMAC hips [12 of 26] versus 22% in the hips with osteoblastic cells [six of 27], hazard ratio, 0.47 [95% CI 0.17 to 1.31]; p = 0.15). There was no clinically important difference in VAS pain scores. No differences were found for either the WOMAC or the Lequesne indexes. With the numbers available, there was no difference in the proportion of patients in the groups who underwent THA at 36 months 15% (four of 27) with osteoblastic cells versus 35% (nine of 26) with BMAC; p = 0.09 With the numbers available, we found no differences between the treatment and control groups in terms of the frequencies of major adverse events.ConclusionsWe found no benefit to osteoblastic cells over BMAC in patients with pre-collapse ONFH; side effects were uncommon and generally mild in both groups. This study could be used as pilot data to help determine sample sizes for larger (presumably multicenter) randomized controlled trials. However, this novel treatment cannot be recommended in routine practice until future, larger studies demonstrate efficacy.Level of evidenceLevel II, therapeutic study.

Project description:BackgroundDespite several surgical options, there remains no consensus regarding the optimal approach for osteonecrosis of the femoral head (ONFH), a prevalent and refractory disease. To determine the most suitable treatment modality, we compared randomized controlled trials (RCTs) that evaluated multiple surgical treatments for ONFH using a Bayesian network meta-analysis (NMA).MethodsThe outcomes of 11 different surgical treatments were assessed using NMA comparisons of the rate of progression of femoral head necrosis, the rate of conversion to total hip arthroplasty, and improvement of the Harris hip score (HHS). A random effects model was used to analyze the odds ratio (OR) or mean difference, and risk of bias was assessed using the Cochrane risk of bias assessment tool for randomized trials. The confidence of the results was assessed using the confidence in network meta-analysis tool.ResultsA total of 18 RCTs were included in the meta-analysis. Compared with core decompression (CD), the forest plot showed that autologous bone grafting (ABG), free fibula grafting (FFG), vascularized bone grafting (VBG), autologous bone grafting combined with bone marrow aspirate concentrate (ABG + BMAC), and biomaterial grafting combined with vascularized bone grafting (BMG + VBG) delayed ONFH progression. Among them, ABG + BMAC showed the most promising results (OR 0.019; 95% confidence interval [CI] 0.0012-0.25). However, upon comparing CD with different surgical modalities, no significant differences were found in preventing total hip arthroplasty. Furthermore, we cannot draw conclusions regarding the HHS due to attribution and high heterogeneity across the studies.ConclusionOverall, ABG, VBG, FFG, ABG + BMAC, and BMG + VBG showed significant results in preventing ONFH progression compared with that shown by CD. Based on the surface under the cumulative ranking, ABG + BMAC was the most effective. Moreover, all treatments involving bone grafting were found to be effective, possibly indicating the necessity of its use in the treatment of ONFH.

Project description:BackgroundWnt/β-catenin signaling pathway is closely related to the pathogenesis Osteonecrosis of the femoral head (ONFH). β-catenin, as a major component of Wnt signaling pathway, plays a vital role in the proliferation of osteoblasts. But the effect of altering β-catenin level on the early diagnosis and staging of ONFH has not been studied. Our purpose is to investigate the role of β-catenin level in the progress of ONFH.MethodOne hundred and one patients with three stages of ONFH and fifty healthy controls were recruited between May 2016 and November 2016. We divided the patients into 32 cases of stage II, 41 cases of stage III and 28 cases of stage IV according to the Association Research Circulation Osseous (ARCO) classification. We evaluated the clinical bone histomorphology, expression position and level of β-catenin as well as the plasma β-catenin level. We investigated the level of β-catenin from the serum and tissue samples using ELISA and Western Blot assay. We also evaluated the expression of β-catenin in bone tissue by immunohistochemistry. Data were analyzed by independent t-test and ANOVA.ResultsWe found that the mean (± SD) serum level of β-catenin was 66.99 ± 3.032 ng/ml in the ONFH patients, which was higher than 20.14 ± 1.715 ng/ml observed in the control group (P < 0.001). Moreover, the β-catenin levels were 49.30 ± 4.649 ng/ml, 72.54 ± 4.864 ng/ml and 79.10 ± 4.773 ng/ml in the ONFH patients with ARCO stage II, stage III and stage IV respectively, showing significant difference among them (P < 0.001). We also found that the area under the curve (AUC) calculated by ROC curve analysis to determine the values for β-catenin levels in ONFH compared with those in the control group was 0.9358 (P < 0.001), where the sensitivity was 77.23% and specificity was 98.00%.ConclusionOur results indicate that the increased β-catenin may play a vital role in the progress of ONFH and the level of β-catenin is correlated with ARCO stages. The cut-off concentration may be used as one of the sensitive marks to assess the disease process of ONFH.

Dataset Information

Treatment of Pre-Collapse Stages of Osteonecrosis of the Femoral Head: a Systematic Review of Randomized Control Trials.

Background

Questions/purposes

Methods

Results

Conclusion

Publications

Treatment of Pre-Collapse Stages of Osteonecrosis of the Femoral Head: a Systematic Review of Randomized Control Trials.

Similar Datasets

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