Clinical Performance and Outcomes of an Injectable Bone Graft Substitute Following Core Decompression during the Treatment of Osteonecrosis of the Femoral Head

Abstract

Osteonecrosis of the femoral head (ONFH) can be challenging to manage, as it primarily affects younger adult patients. Hip preservation is preferred in this population, and there is a heightened focus on treatment strategies such as biologic adjuvants and bone grafting. Therefore, the objective of this systematic literature review was to evaluate the clinical performance of a commercially available injectable bone graft substitute (calcium sulfate [CaSO₄]/calcium phosphate [CaPO₄]; Pro-Dense, Wright Medical Technology Inc., Memphis, TN) following core decompression for the management of ONFH. Specifically, we aimed to examine (1) patient-reported outcomes, (2) progression of disease, (3) rate of revision, and (4) complications. A systematic literature review was performed in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analyses, using PubMed, Google Scholar, and Cochrane Library in July 2020 (gap search conducted in March 2022). The review included all clinical studies, published in English, on the use of an injectable bone graft substitute in ONFH-related procedures since 2007. Meta-analysis was conducted on Harris Hip Score (HHS), Visual Analog Scale (VAS), progression of disease, rate of revision, and complications. Nine studies were identified, with a total of 390 subjects ranging in age from 15 to 70 (weighted mean = 40.4) years old, with a weighted mean follow-up time of 37.1 months. Weighted mean improvement in HHS was +17.5 points (n = 296 procedures), while weighted mean improvement in VAS score was –3.0 points (n = 188 procedures). Overall weighted progression of disease for all patients was 6.1% (n = 17.9), including studies reporting precollapse (5.9%; n = 9.1/155) and/or postcollapse (9.91%; n = 16/162) lesions. Overall weighted revision rate was 2.9% (n = 11.5/390), including studies reporting precollapse (3.2%; n = 7.7/239) and/or postcollapse (4.3%; n = 8.2/191) lesions. The minor complication rate was 1.02% (n = 3/293), with no major complications reported. Clinical evidence on injectable CaSO₄/CaPO₄ bone graft substitute supports an acceptable benefit–risk profile, including safe real-world use since 2007, following core decompression for the treatment of ONFH.

Keywords

hip preservation - osteonecrosis of the femoral head - bone grafting - PRO-DENSE - outcomes

• References

• 1 Moya-Angeler J, Gianakos AL, Villa JC, Ni A, Lane JM. Current concepts on osteonecrosis of the femoral head. World J Orthop 2015; 6 (08) 590-601
• 2 Sodhi N, Anis HK, Coste M, Piuzzi NS, Jones LC, Mont MA. Thirty-day complications in osteonecrosis patients following total hip arthroplasty. J Arthroplasty 2020; 35 (08) 2136-2143
• 3 Shah KN, Racine J, Jones LC, Aaron RK. Pathophysiology and risk factors for osteonecrosis. Curr Rev Musculoskelet Med 2015; 8 (03) 201-209
• 4 Mont MA, Salem HS, Piuzzi NS, Goodman SB, Jones LC. Nontraumatic osteonecrosis of the femoral head: where do we stand today?: a 5-year update. J Bone Joint Surg Am 2020; 102 (12) 1084-1099
• 5 Barney J, Piuzzi NS, Akhondi H. Femoral Head Avascular Necrosis. Treasure Island, FL: StatPearls Publishing; 2022
• 6 Landgraeber S, Warwas S, Claßen T, Jäger M. Modifications to advanced Core decompression for treatment of avascular necrosis of the femoral head. BMC Musculoskelet Disord 2017; 18 (01) 479
• 7 Piuzzi NS, Chahla J, Schrock JB. et al. Evidence for the use of cell-based therapy for the treatment of osteonecrosis of the femoral head: a systematic review of the literature. J Arthroplasty 2017; 32 (05) 1698-1708
• 8 Chughtai M, Piuzzi NS, Khlopas A, Jones LC, Goodman SB, Mont MA. An evidence-based guide to the treatment of osteonecrosis of the femoral head. Bone Joint J 2017; 99-B (10) 1267-1279
• 9 Sionek A, Czwojdziński A, Kowalczewski J. et al. Hip osteonecroses treated with calcium sulfate-calcium phosphate bone graft substitute have different results according to the cause of osteonecrosis: alcohol abuse or corticosteroid-induced. Int Orthop 2018; 42 (07) 1491-1498
• 10 Piuzzi NS, Chahla J, Jiandong H. et al. Analysis of cell therapies used in clinical trials for the treatment of osteonecrosis of the femoral head: a systematic review of the literature. J Arthroplasty 2017; 32 (08) 2612-2618
• 11 Bednarek A, Atras A, Gągała J, Kozak Ł. Operative technique and results of core decompression and filling with bone grafts in the treatment of osteonecrosis of femoral head. Ortop Traumatol Rehabil 2010; 12 (06) 511-518
• 12 Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Open Med 2009; 3 (03) e123-e130
• 13 OCEBM Levels of Evidence—Centre for Evidence-Based Medicine (CEBM). University of Oxford. Accessed at: Zugriff am 23. April 2022 unter: https://www.cebm.ox.ac.uk/resources/levels-of-evidence/ocebm-levels-of-evidence
• 14 Gardeniers JWM. ARCO committee on terminology and staging (report on the committee meeting at Santiago De Compostela). ARCO Newslett 1993; 5: 79-82
• 15 Steinberg ME. Diagnostic imaging and the role of stage and lesion size in determining outcome in osteonecrosis of the femoral head. Tech Orthop 2001; 16 (01) 6-15
• 16 Ficat RP. Idiopathic bone necrosis of the femoral head: early diagnosis and treatment. J Bone Joint Surg Br 1985; 67: 3-9
• 17 Civinini R, De Biase P, Carulli C. et al. The use of an injectable calcium sulphate/calcium phosphate bioceramic in the treatment of osteonecrosis of the femoral head. Int Orthop 2012; 36 (08) 1583-1588
• 18 Classen T, Warwas S, Jäger M, Landgraeber S. Two-year follow-up after advanced core decompression. J Tissue Eng Regen Med 2017; 11 (04) 1308-1314
• 19 Landgraeber S, Theysohn JM, Classen T. et al. Advanced core decompression, a new treatment option of avascular necrosis of the femoral head–a first follow-up. J Tissue Eng Regen Med 2013; 7 (11) 893-900
• 20 Liu P, Zhang QD, Wang Y. et al. One-stage total hip arthroplasty and “light-bulb” procedure for bilateral non-traumatic osteonecrosis of femoral head in different stages. Chin Med J (Engl) 2019; 132 (23) 2883-2885
• 21 Yu PA, Peng KT, Huang TW, Hsu RW, Hsu WH, Lee MS. Injectable synthetic bone graft substitute combined with core decompression in the treatment of advanced osteonecrosis of the femoral head: a 5-year follow-up. Biomed J 2015; 38 (03) 257-261
• 22 Landgraeber S, Tran TN, Claßen T. et al. Geometric analysis of an expandable reamer for treatment of avascular necrosis of the femoral head. Arch Orthop Trauma Surg 2015; 135 (10) 1357-1362
• 23 D'Ambrosi R, Biancardi E, Massari G, Ragone V, Facchini RM. Survival analysis after core decompression in association with platelet-rich plasma, mesenchymal stem cells, and synthetic bone graft in patients with osteonecrosis of the femoral head. Joints 2018; 6 (01) 16-22
• 24 Piuzzi NS, Anis HK, Muschler GF. Osteonecrosis of the femoral head with subchondral collapse. Cleve Clin J Med 2019; 86 (08) 511-512
• 25 Michael K-O, Kody B, Monti K. Algorithm for treatment of hip and knee osteonecrosis: review and a presentation of three example cases. J Rheum Dis Treat 2017;
• 26 Rocchi M, Del Piccolo N, Mazzotta A. et al. Core decompression with bone chips allograft in combination with fibrin platelet-rich plasma and concentrated autologous mesenchymal stromal cells, isolated from bone marrow: results for the treatment of avascular necrosis of the femoral head after 2 years minimum follow-up. Hip Int 2020; 30 (2_suppl, suppl): 3-12
• 27 Zhang L, Zhang J, Liang D. et al. Clinical study on minimally invasive treatment of femoral head necrosis with two different bone graft materials. Int Orthop 2021; 45 (03) 585-591
• 28 Li D, Xie X, Kang P, Shen B, Pei F, Wang C. Percutaneously drilling through femoral head and neck fenestration combining with compacted autograft for early femoral head necrosis: a retrospective study. J Orthop Sci 2017; 22 (06) 1060-1065
• 29 Kuroda Y, Nankaku M, Okuzu Y, Kawai T, Goto K, Matsuda S. Percutaneous autologous impaction bone graft for advanced femoral head osteonecrosis: a retrospective observational study of unsatisfactory short-term outcomes. J Orthop Surg Res 2021; 16 (01) 141
• 30 Jie K, Feng W, Li F. et al. Long-term survival and clinical outcomes of non-vascularized autologous and allogeneic fibular grafts are comparable for treating osteonecrosis of the femoral head. J Orthop Surg Res 2021; 16 (01) 109
• 31 Wei BF, Ge XH. Treatment of osteonecrosis of the femoral head with core decompression and bone grafting. Hip Int 2011; 21 (02) 206-210