Implantation of autologous Expanded Mesenchymal Stromal Cells in Hip Osteonecrosis through Percutaneous Forage: Evaluation of the Operative Technique.

Enrique Gómez-Barrena,Reborne Consortium,Norma Padilla-Eguiluz

doi:10.3390/jcm10040743

Abstract

Bone forage to treat early osteonecrosis of the femoral head (ONFH) has evolved as the channel to percutaneously deliver cell therapy into the femoral head. However, its efficacy is variable and the drivers towards higher efficacy are currently unknown. The aim of this study was to evaluate the forage technique and correlate it with the efficacy to heal ONFH in a multicentric, multinational clinical trial to implant autologous mesenchymal stromal cells expanded from bone marrow (BM-hMSCs). Methods: In the context of EudraCT 2012-002010-39, patients with small and medium-sized (mean volume = 13.3%, range: 5.4 to 32.2) ONFH stage II (Ficat, ARCO, Steinberg) C1 and C2 (Japanese Investigation Committee (JIC)) were treated with percutaneous forage and implantation of 140 million BM-hMSCs in a standardized manner. Postoperative hip radiographs (AP—anteroposterior and lateral), and MRI sections (coronal and transverse) were retrospectively evaluated in 22 patients to assess the femoral head drilling orientation in both planes, and its relation to the necrotic area. Results: Treatment efficacy was similar in C1 and C2 (coronal plane) and in anterior to posterior (transverse plane) osteonecrotic lesions. The drill crossed the sclerotic rim in all cases. The forage was placed slightly valgus, at 139.3 ± 8.4 grades (range, 125.5–159.3) with higher dispersion (f = 2.6; p = 0.034) than the anatomical cervicodiaphyseal angle. Bonferroni’s correlation between both angles was 0.50 (p = 0.028). More failures were seen with a varus drill positioning, aiming at the central area of the femoral head, outside the weight-bearing area (WBA) (p = 0.049). In the transverse plane, the anterior positioning of the drill did not result in better outcomes (p = 0.477). Conclusion: The forage drilling to deliver cells should be positioned within the WBA in the coronal plane, avoiding varus positioning, and central to anterior in the transverse plane. The efficacy of delivered MSCs to regenerate bone in ONFH could be influenced by the drilling direction. Standardization of this surgical technique is desirable.

Highlights

Treatments for osteonecrosis of the femoral head (ONFH) are still a matter of considerable debate
To meet the aim of the study, we evaluated the efficacy of the technique related to the location of the osteonecrosis and the location of the forage tunnel
There was no difference in efficacy related to the Japanese Investigation Committee (JIC) extension of the lesion in the coronal plane, whether the extension was evaluated in radiographs (Fisher’s exact test ji2 = 2.3; p = 0.311) or in MRI (Fisher’s exact ji2 = 0.8; p = 0.613)

Summary

Introduction

Treatments for osteonecrosis of the femoral head (ONFH) are still a matter of considerable debate. Non-operative treatments have been associated with high radiographic failure rates (at a mean of 72%) consistently throughout the years [1]. Due to a high degree of heterogeneity across various studies, best individual stage-dependent treatment options and especially the correct indications for surgical treatment are largely unknown. Treatment with forage drilling, the so-called core decompression (CD), is the classic joint-preserving alternative to treat early cases of ONFH, initially proposed to decrease the intraosseous pressure in avascular osteonecrosis of the femoral head [2]. Radiological progression after forage averaged 44% of treated cases in studies done before 1992, with an improvement to 37% failure in more recent studies [1]

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