This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vertebral Bone Marrow Clot for Spinal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05947175
Recruitment Status : Recruiting
First Posted : July 17, 2023
Last Update Posted : July 17, 2023
Sponsor:
Information provided by (Responsible Party):
Francesca Salamanna, Istituto Ortopedico Rizzoli

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Degenerative Spine Diseases Biological: Vertebral bone marrow (vBMA) clot Other: Bone allograft chips Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Vertebral Bone Marrow Clot as Autologous Cell-therapy and Multifunctional Bio-scaffold Targeting the Key Challenges for Spinal Fusion Surgery
Actual Study Start Date : May 19, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : May 18, 2026

Arm Intervention/treatment
Experimental: Experimental group - vertebral bone marrow (vBMA) clot
Bone allograft chips will be obtained from Istituto Ortopedico Rizzoli while vBMA will be harvested from each patient vertebral pedicle with the preparation of the site for pedicle screw insertion during spinal surgery. After the positioning of pedicle screws, the decompression of the cauda and nerve roots will be achieved with a hemilaminectomy and foraminotomy. vBMA clot associated with bone allograft chips will be opposed on the hemi-laminae and transvers process on the contralateral side of the hemilaminectomy. On the hemilaminectomy side, foramino-arthrectomy will be performed to insert the interbody fusion cage if necessary. After aspiration, the vBMA will be clotted and used for surgical procedure. vBMA clot associated to bone allograft chips will be applied on each side of the vertebra according to the number of segments to be fused.
Biological: Vertebral bone marrow (vBMA) clot
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.

Active Comparator: Control - bone allograft chips
Bone allograft chips will be obtained from Istituto Ortopedico Rizzoli. In detail, conventional posterior approach for lumbar SF will be performed. After the positioning of pedicle screws, the decompression of the cauda and nerve roots will be achieved with a hemilaminectomy and foraminotomy. Bone allograft chips alone will be opposed on the hemi-laminae and transvers process on the contralateral side of the hemilaminectomy. On the hemilaminectomy side, foramino-arthrectomy will be performed to insert the interbody fusion cage if necessary.
Other: Bone allograft chips
Bone allograft chips will be obtained from Musculoskeletal Tissue Bank at IRCCS Istituto Ortopedico Rizzoli.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05947175


Contacts
Layout table for location contacts
Contact: Francesca Salamanna, PhD +390516366004 francesca.salamanna@ior.it
Contact: Maria Sartori, PhD +390516366787 maria.sartori@ior.it

Locations
Layout table for location information
Italy
Istituto Ortopedico Rizzoli Recruiting
Bologna, BO, Italy, 40136
Contact: Giuseppe Tedesco, MD         
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Publications of Results:
Layout table for additonal information
Responsible Party: Francesca Salamanna, Principal Investigator, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT05947175    
Other Study ID Numbers: MORE_FOR_SPINE
First Posted: July 17, 2023    Key Record Dates
Last Update Posted: July 17, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesca Salamanna, Istituto Ortopedico Rizzoli:
Spine
Spinal fusion
Degenerative diseases
Vertebral bone marrow
Clot
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases