Inefficacy of autologous bone marrow concentrate in stage three osteonecrosis: a randomized controlled double-blind trial

Abstract

Purpose The fracture stage of non-traumatic osteonecrosis (ON stage 3) of the femoral head (ONFH) has an unfavourable prognosis frequently requiring total hip replacement (THR). The percentage could be lowered after core decompression. In earlier non-fracture ON stages, implantation of autologous bone marrow aspirate concentrate (BMAC) improved the effect of core decompression. The purpose was to evaluate the effect of BMAC in addition to core decompression in stage 3 ONFH. Methods A double blind RCT was conducted comparing two groups: core decompression plus saline injection or core decompression plus BMAC implantation. Both patients and assessors were blinded to the treatment assignments. Evaluations were done at baseline, three, six, 12, and 24 months, including pain (VAS), WOMAC, side-effects, radiological evolution including ARCO subclassifications, together with possible THR requirement. The primary endpoint was the need for THR. The second endpoints included the clinical symptoms such as pain and functional ability and the progression of the ON lesions as well as the appearance of osteoarthritis features (ARCO stage 4). Both groups included 23 hips (19 patients).Results No differences were found between the groups for THR requirements, clinical tests, and radiological evolution. In both groups, 15/23 hips needed THR. The radiological evolution of the ONFH lesions in term of location, extension, surface collapse, and dome depression was moderate in both groups and was not correlated with the need of THR. Conclusions Implantation of BMAC after core decompression did not produce any improvement of the evolution of ONFH stage 3.Level of evidence I.

Hip osteonecrosis: stem cells for life or behead and arthroplasty?

“…The authors [37,[40][41][42][43][44] of this issue critically address specific problems-namely cell quality and competence, and microenvironmental changes occurring at the bone osteonecrosis level. BMSC-which are supposed to be Bfunctionally competent^-are often being collected from the BM of patients with bone disease and concomitant risk factors for bone marrow disease (corticosteroids, alcohol abuse…).…”

Regenerative Sports Medicine: Past, Present, and Future (Adapted From the PASSOR Legacy Award Presentation; AAPMR; October 2016)

“…This study compared 2 groups: core decompression plus saline injection compared with core decompression plus BMAC implantation. No differences were found in total hip replacement requirements, clinical symptoms, or radiologic results through 2‐year follow‐up [108]. However, a level II study by Pilge et al [109] showed that the BMAC group had a decreased need for hip arthroplasty.…”

“…The only level I study using BMAC reported at the time of this review [108] treated patients with stage 3 osteonecrosis of the femoral head. This study compared 2 groups: core decompression plus saline injection compared with core decompression plus BMAC implantation.…”

“…In summary, there are no level I studies to support the use of BMAC in musculoskeletal disorders typically encountered by physiatrists. This is clearly a topic in need of further rigorous research (Table 3) [108][109][110][111][112][113][114][115][116][117][118][119][120][121][122][123][124][125][126][127].…”

Letter to editor concerning the article “muscle pedicle bone grafting using the anterior one-third of the gluteus medius attached to the greater trochanter for treatment of Association Research Circulation Osseous stage II osteonecrosis of the femoral head” (Cho KJ et al. International Orthopaedics. doi: 10.1007/s00264-018-3839-5)

“…The technique is encouraging and I would like to congratulate authors for their study, theoretically, procedures that provide a blood supply for necrotic area could be more effective than conventional CD or even structural allografts. Conversion to total hip arthroplasty (THA) and any progress or changes in staging were considered as outcome measurement in this study which are used repeatedly in same studies [3][4][5]. The authors reported success rate of 87.5% because at final followup, only three out of 24 hips have been converted to THA; I do not agree with this result.…”