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

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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.

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Acknowledgments

We thank Pierre Cullus of the Department of Biostatistics and Medical Informatics & IRIBHM, School of Medicine, Université Libre de Bruxelles, for his contribution to data analyses.

Funding

Funding was received from the Fund for Scientific Research of Belgium (FNRS) and the hospitals communities, University hospital of Liège and the Erasme hospital.

Author information

Authors and Affiliations

  1. Department of Rheumatology, CHU de Liège, University of Liège, B 4000, Liège, Belgium

    Jean-Philippe Hauzeur & Michel Malaise

  2. Department of Rheumatology and Physical Medicine, Hôpital Erasme, Université Libre de Bruxelles, 808 Route de Lennik, 1070, Brussels, Belgium

    Jean-Philippe Hauzeur & Valérie Gangji

  3. Department of Biostatistics and Medical Informatics & IRIBHM, School of Medicine, Université Libre de Bruxelles, ULB, 808 route de Lennik, 1070, Brussels, Belgium

    Viviane De Maertelaer

  4. Laboratory of Cell and Gene Therapy, CHU de Liège, University of Liège, Liège, Belgium

    Etienne Baudoux & Yves Beguin

Authors
  1. Jean-Philippe Hauzeur
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  2. Viviane De Maertelaer
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  3. Etienne Baudoux
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  4. Michel Malaise
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  5. Yves Beguin
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  6. Valérie Gangji
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Corresponding author

Correspondence to Jean-Philippe Hauzeur.

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Conflict of interest

The authors declare no conflict of interest.

Ethical review committee statement

All the authors confirm that the work described has not been published before; that it is not under consideration for publication anywhere else; that its publication has been approved by all coauthors, if any, as well as by the responsible authorities — tacitly or explicitly — at the institute where the work has been carried out.

Informed consent

Informed consent was obtained from all individual participants included in the study.

The protocol was accepted by the ethical committees of both institutions. This trial was registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT01544712).

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Hauzeur, JP., De Maertelaer, V., Baudoux, E. et al. Inefficacy of autologous bone marrow concentrate in stage three osteonecrosis: a randomized controlled double-blind trial. International Orthopaedics (SICOT) 42, 1429–1435 (2018). https://doi.org/10.1007/s00264-017-3650-8

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  • DOI: https://doi.org/10.1007/s00264-017-3650-8

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