Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis

Abstract

Background: Early diagnosis and treatment of the osteonecrosis of the femoral head (ONFH), a refractory disease, is imperative to prevent femoral head collapse; however, the existing solutions remain controversial. This study assessed the safety and efficacy of extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection, a novel cocktail therapy, as a randomized controlled trial (RCT) model to postulate an alternative therapy for patients with early-stage ONFH. Methods: Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited. One hundred twenty eligible participants were randomized into four groups in a 1:1:1:1 ratio: extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling (“positive” control group; group M). The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema. Secondary outcomes included the Harris Hip Score and the visual analog scale. All outcomes were measured at the screening visit (baseline) and at the planned time intervals during treatment and follow-up, and the efficacy was statistically analyzed according to the intention-to-treat sub-populations and per-protocol sub-populations. Objectives: To examine the clinical efficacy of ESWT combined with multiple drilling and intramedullary drug injection to provide a safe and more effective method for treating early-stage ONFH. Trial registration number: ChiCTR1900020888; Pre-results.

Epidemiological and survival analysis of early and middle stage femoral head necrosis

“…The operations adopted by our hospital for early and medium-term ONFH mainly include MSFLD and hip arthroscopy + MSFLD. MSFLD, that is, using 3.0 Kirschner wire, for the femoral head necrosis area, fan-shaped drilling decompression in different directions, different depths, and the number of porous channels [19][20][21] . In most cases, 3-5 holes were drilled, and in a few cases with small necrosis, 2 holes were drilled.…”

Effect of three clinical therapies on cytokines modulation in the hip articular cartilage and bone improvement in rat early osteonecrosis of the femoral head

“…ESWT was suggested to promote angiogenesis, bone remodelling and regenerative effect in ONFH [ 31 , 32 ]. Clinically, studies have shown that ESWT is effective in the treatment of early stage ONFH [ 33 , 34 ]. Physical ESWT can enhance bone marrow stromal cell differentiation into osteoprogenitors by transforming growth factor-beta 1 induction [ [35] , [36] , [37] ].…”