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

ACCESS DATA

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:OBJECTIVES:Autologous 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. METHODS:After 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. RESULTS:In 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. CONCLUSIONS:The 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.

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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