Did Osteoblastic Cell Therapy Improve the Prognosis of Pre-fracture Osteonecrosis of the Femoral Head? A Randomized, Controlled Trial.

BACKGROUND: In 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? METHODS: Between 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. RESULTS: At 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. CONCLUSIONS: We 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 EVIDENCE: Level II, therapeutic study.

Prevalence and frequency of subchondral bone marrow edema in the lumbar facet joints of asymptomatic and symptomatic individuals.

OBJECTIVE: To prospectively compare the prevalence and frequency of subchondral bone marrow edema (BME) in the lumbar facet joints of low back pain patients and healthy subjects. MATERIALS AND METHODS: Lumbar magnetic resonance imaging (MRI) examinations were performed on 55 asymptomatic participants (18 men; age range 21-63; mean 36 ± 12 years; body mass index (BMI) range 16-31; mean 22.6 ± 3.2 kg/m2) and 79 low back pain patients (36 men; age range 18-77; mean 47 ± 14 years; BMI range 18-40; mean 27.8 ± 4.4 kg/m2). In both groups, facet joint subchondral BME signal was evaluated using T2-weighted STIR imaging, and facet joint osteoarthritis was characterized as mild, moderate, and severe. RESULTS: The BME signal was found in seven asymptomatic participants (12.7%) and 28 low back pain patients (35.4%) (P = 0.003). A significant portion of the patients (15.2%) presented more than one BME signal (P = 0.011). By pooling the ten facet joints of all subjects in each group, a significant difference in osteoarthritis grade distribution was observed between the two groups (P < 0.001). When adjusted for low back pain status, age, BMI, Modic type 1, disk herniation, and facet joint osteoarthritis maximal grade, only the latter was significantly associated with the facet joint BME signal (P < 0.001). CONCLUSION: Despite the higher prevalence and frequency of the BME signal in facet joints of low back pain patients compared to that in healthy subjects, the signal was found to be associated with the severity of the patients' osteoarthritis and not with their low back pain status.

Case report of a spontaneous splenic rupture in a patient with chronic lymphocytic leukaemia treated by arterial splenic embolization.

INTRODUCTION AND IMPORTANCE: Spontaneous splenic rupture (SSR) is a rare phenomenon where the spleen ruptures without associated trauma. SSR can lead to an intra-abdominal haemorrhage and an acute abdomen that can be life threatening. CASE PRESENTATION: In this article, we present the case of an 81-year-old woman with chronic lymphocytic leukaemia who presented to the emergency department with severe abdominal pain. CLINICAL DISCUSSION: In order to stabilize the patient, while awaiting elective surgery, we managed the rupture with splenic embolization and we reviewed the literature related to the treatments of SSR especially, by arterial splenic embolization. CONCLUSION: Splenic embolization is a safe treatment option, that allows a rapid stabilization and has the advantage of both, splenectomy and conservative treatment.