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Abstract <p>Osteonecrosis (ON) of bone is a serious and progressive condition affecting younger individuals and leads to the death and collapse of bone and subsequent degenerative arthritis. Orthobiologics are natural substances used to enhance the healing or regeneration of musculoskeletal tissues. We emphasize the need for early intervention in ON to prevent the ongoing collapse of bone and joint destruction and the potential utility of combining a minimally invasive surgical procedure, core decompression (CD), with orthobiologics, such as bone marrow aspirate concentrate (BMAC), to enhance bone healing. Several clinical studies suggest that adding cell-based therapies to CD improves outcomes in early-stage ON of the femoral head (ONFH), reducing the need for total hip arthroplasty. The “Bone Marrow Aspirate Concentrate Treatment for Osteonecrosis” or “BATON” study is a prospective, blinded, multicenter study designed to evaluate the efficacy of CD augmented with autogenous BMAC compared to CD alone in patients who have early-stage ONFH. This study will use standardized surgical techniques and methods of assessment for patients who have an early-stage disease (Association Research Circulation Osseous or ARCO stages I and II) who do not have femoral head collapse and includes two groups: the experimental group undergoing CD with autogenous BMAC and the comparator group undergoing CD alone. The primary outcome measures include radiological progression of ONFH to the more advanced ARCO stages III or IV, change in pain using the visual analogue scale, and time to collapse of the femoral head. Secondary outcome measures are collected at baseline, 6&#xa0;months, 1, and 2&#xa0;years, and include patient-reported outcomes and physician assessments, and at baseline, cellular characterizations of the BMAC by mass cytometry by time-of-flight (CyTOF). This pivotal study will determine the efficacy of CD augmented with BMAC compared to CD alone in preserving rather than replacing the hip joint in patients who have ONFH. </p> Lay Summary <p>We report the salient studies relevant to the use of different types of cell injections into the femoral head (FH) for treatment of early-stage osteonecrosis (ON), a condition in young adults in which the marrow contents of the FH die. These treatments are given to prevent collapse of the FH and subsequent arthritis of the hip. We describe a prospective, blinded, multicenter clinical trial called the BATON study. Participants include patients with early-stage ONFH (ARCO stages I and II) who have not yet experienced FH collapse. The study compares two groups: one undergoing drilling into the ON area of the FH (core decompression or CD) alone, versus another in which CD is supplemented with injected bone marrow aspirate concentrate (BMAC). The addition of BMAC to CD may improve bone healing, prevent FH collapse, and reduce the need for total hip arthroplasty. This research could lead to better treatment options for patients with early-stage ONFH, potentially preserving their hip joints and improving their quality of life.</p>

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Orthobiologics for the Treatment of Osteonecrosis: The Need for a Prospective Randomized Clinical Trial

  • 期刊论文

  • 发表日期：

    2025年7月28日

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  • Stuart B. Goodman,
  • Joshua P. Rainey,
  • Simon K. Chow,
  • Michael A. Mont,
  • Lynne P. Jones

摘要

Abstract

Osteonecrosis (ON) of bone is a serious and progressive condition affecting younger individuals and leads to the death and collapse of bone and subsequent degenerative arthritis. Orthobiologics are natural substances used to enhance the healing or regeneration of musculoskeletal tissues. We emphasize the need for early intervention in ON to prevent the ongoing collapse of bone and joint destruction and the potential utility of combining a minimally invasive surgical procedure, core decompression (CD), with orthobiologics, such as bone marrow aspirate concentrate (BMAC), to enhance bone healing. Several clinical studies suggest that adding cell-based therapies to CD improves outcomes in early-stage ON of the femoral head (ONFH), reducing the need for total hip arthroplasty. The “Bone Marrow Aspirate Concentrate Treatment for Osteonecrosis” or “BATON” study is a prospective, blinded, multicenter study designed to evaluate the efficacy of CD augmented with autogenous BMAC compared to CD alone in patients who have early-stage ONFH. This study will use standardized surgical techniques and methods of assessment for patients who have an early-stage disease (Association Research Circulation Osseous or ARCO stages I and II) who do not have femoral head collapse and includes two groups: the experimental group undergoing CD with autogenous BMAC and the comparator group undergoing CD alone. The primary outcome measures include radiological progression of ONFH to the more advanced ARCO stages III or IV, change in pain using the visual analogue scale, and time to collapse of the femoral head. Secondary outcome measures are collected at baseline, 6 months, 1, and 2 years, and include patient-reported outcomes and physician assessments, and at baseline, cellular characterizations of the BMAC by mass cytometry by time-of-flight (CyTOF). This pivotal study will determine the efficacy of CD augmented with BMAC compared to CD alone in preserving rather than replacing the hip joint in patients who have ONFH.

Lay Summary

We report the salient studies relevant to the use of different types of cell injections into the femoral head (FH) for treatment of early-stage osteonecrosis (ON), a condition in young adults in which the marrow contents of the FH die. These treatments are given to prevent collapse of the FH and subsequent arthritis of the hip. We describe a prospective, blinded, multicenter clinical trial called the BATON study. Participants include patients with early-stage ONFH (ARCO stages I and II) who have not yet experienced FH collapse. The study compares two groups: one undergoing drilling into the ON area of the FH (core decompression or CD) alone, versus another in which CD is supplemented with injected bone marrow aspirate concentrate (BMAC). The addition of BMAC to CD may improve bone healing, prevent FH collapse, and reduce the need for total hip arthroplasty. This research could lead to better treatment options for patients with early-stage ONFH, potentially preserving their hip joints and improving their quality of life.