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NCT Number: NCT05947175

Vertebral Bone Marrow Clot for Spinal Surgery

Spinal fusion (SF) is a common orthopedic procedure to treat spinal diseases. Apart from fixation systems, the procedure requires bone grafting to further improve SF. Cell-based therapies as vertebral bone marrow aspirate (vBMA) with bone allograft were developed as alternative to bone autograft in SF. However, vBMA use is limited by the lack of a standardized procedure, of a structural texture and by the possibility of diffusion away from the implant site. Recently, the potential use of a new formulation of vBMA, named vBMA clot, has been described. The project aims at evaluating the clinical evidence and the biological features of vBMA clot associated to bone allograft for SF surgery, considering age and gender related differences. A randomized controlled trial will prove the efficacy of the treatment and advanced preclinical studies will improve the knowledge on vBMA clot regenerative and anti-inflammatory properties, exploring for the first time its antibacterial characteristics.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Degenerative Spine Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

About this study

To evaluate the efficacy of autologous vBMA clot in SF procedures in patients with degenerative spine diseases, a randomized controlled trial (RCT) will be carried out. The study will compare patients treated with autologous vBMA clot associated to bone allograft chips versus bone allograft chips alone (standard treatment), also evaluating whether patient age and gender are associated with differences in the clinical outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • degenerative spinal disorders (based radiological diagnosis)
  • posterior spinal stabilization ≤ 5 levels
  • age between 18-80 years at the time of surgery

Exclusion criteria

  • HIV
  • HBV
  • HCV
  • coagulations disorders
  • pregnant or breast-feeding women
  • cancer
  • infections
  • previous spinal surgery
  • radio- chemotherapy
  • myeloproliferative disease
  • chronic steroid medication, thyroxin, immunodepression

Treatment and study plan

Vertebral bone marrow (vBMA) clot

Biological

The clotted vBMA will be obtained from vertebral bone marrow aspirate.The vBMA clot contain mesenchymal stem cells (MSCs), growth factors, platelet and osteogenic and anti-inflammatory mediators.

Bone allograft chips

Other

Bone allograft chips will be obtained from Musculoskeletal Tissue Bank at IRCCS Istituto Ortopedico Rizzoli.

Primary outcomes

  1. Brantigan classification

    Time frame: At baseline (day 0)

    Improvement of spinal fusion rate and time in patients treated with vBMA clot associated to bone allograft chips in comparison to bone allograft chips alone, also considering age and gender differences. CT-scan and X-ray, perform pre-operatively and at 1, 3, 6, 12 months of FU, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate).

  2. Brantigan classification

    Time frame: 1 month

    Improvement of spinal fusion rate and time in patients treated with vBMA clot associated to bone allograft chips in comparison to bone allograft chips alone, also considering age and gender differences. CT-scan and X-ray, perform pre-operatively and at 1, 3, 6, 12 months of FU, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate).

  3. Brantigan classification

    Time frame: 3 months

    Improvement of spinal fusion rate and time in patients treated with vBMA clot associated to bone allograft chips in comparison to bone allograft chips alone, also considering age and gender differences. CT-scan and X-ray, perform pre-operatively and at 1, 3, 6, 12 months of FU, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate).

  4. Brantigan classification

    Time frame: 6 months

    Improvement of spinal fusion rate and time in patients treated with vBMA clot associated to bone allograft chips in comparison to bone allograft chips alone, also considering age and gender differences. CT-scan and X-ray, perform pre-operatively and at 1, 3, 6, 12 months of FU, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate).

  5. Brantigan classification

    Time frame: 12 months

    Improvement of spinal fusion rate and time in patients treated with vBMA clot associated to bone allograft chips in comparison to bone allograft chips alone, also considering age and gender differences. CT-scan and X-ray, perform pre-operatively and at 1, 3, 6, 12 months of FU, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate).

Secondary outcomes

  1. Re-operation rate

    Time frame: At baseline (day 0)

    The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.

  2. Re-operation rate

    Time frame: 1 month

    The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.

  3. Re-operation rate

    Time frame: 3 month

    The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.

  4. Re-operation rate

    Time frame: 6 month

    The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.

  5. Re-operation rate

    Time frame: 12 month

    The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.

  6. Visual Analogue Score

    Time frame: At baseline (day 0)

    Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)

  7. Visual Analogue Score

    Time frame: 1 month

    Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)

  8. Visual Analogue Score

    Time frame: 3 months

    Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)

  9. Visual Analogue Score

    Time frame: 6 months

    Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)

  10. Visual Analogue Score

    Time frame: 12 months

    Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)

  11. Oswestry Disability Index

    Time frame: At baseline (day 0)

    Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)

  12. Oswestry Disability Index

    Time frame: 1 month

    Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)

  13. Oswestry Disability Index

    Time frame: 3 months

    Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)

  14. Oswestry Disability Index

    Time frame: 6 months

    Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)

  15. Oswestry Disability Index

    Time frame: 12 months

    Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)

  16. Short Form Health Survey 36

    Time frame: At baseline (day 0)

    Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)

  17. Short Form Health Survey 36

    Time frame: 1 month

    Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)

  18. Short Form Health Survey 36

    Time frame: 3 months

    Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)

  19. Short Form Health Survey 36

    Time frame: 6 months

    Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)

  20. Short Form Health Survey 36

    Time frame: 12 months

    Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

The Vertebral Bone Marrow Clot as Autologous Cell-therapy and Multifunctional Bio-scaffold Targeting the Key Challenges for Spinal Fusion Surgery

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 17, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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