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Vertebral Bone Marrow Clot for Spinal Surgery

Primary Purpose

Degenerative Spine Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Vertebral bone marrow (vBMA) clot
Bone allograft chips
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Spine Diseases focused on measuring Spine, Spinal fusion, Degenerative diseases, Vertebral bone marrow, Clot

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group - vertebral bone marrow (vBMA) clot

Control - bone allograft chips

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Brantigan classification
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).
Brantigan classification
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).
Brantigan classification
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).
Brantigan classification
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).
Brantigan classification
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

Re-operation rate
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Re-operation rate
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Re-operation rate
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Re-operation rate
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Re-operation rate
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Visual Analogue Score
Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)
Visual Analogue Score
Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)
Visual Analogue Score
Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)
Visual Analogue Score
Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)
Visual Analogue Score
Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)
Oswestry Disability Index
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Oswestry Disability Index
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Oswestry Disability Index
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Oswestry Disability Index
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Oswestry Disability Index
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Short Form Health Survey 36
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Short Form Health Survey 36
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Short Form Health Survey 36
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Short Form Health Survey 36
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Short Form Health Survey 36
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)

Full Information

First Posted
June 27, 2023
Last Updated
July 14, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT05947175
Brief Title
Vertebral Bone Marrow Clot for Spinal Surgery
Official Title
The Vertebral Bone Marrow Clot as Autologous Cell-therapy and Multifunctional Bio-scaffold Targeting the Key Challenges for Spinal Fusion Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
May 18, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Spine Diseases
Keywords
Spine, Spinal fusion, Degenerative diseases, Vertebral bone marrow, Clot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group - vertebral bone marrow (vBMA) clot
Arm Type
Experimental
Arm Description
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.
Arm Title
Control - bone allograft chips
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Vertebral bone marrow (vBMA) clot
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Bone allograft chips
Intervention Description
Bone allograft chips will be obtained from Musculoskeletal Tissue Bank at IRCCS Istituto Ortopedico Rizzoli.
Primary Outcome Measure Information:
Title
Brantigan classification
Description
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).
Time Frame
At baseline (day 0)
Title
Brantigan classification
Description
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).
Time Frame
1 month
Title
Brantigan classification
Description
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).
Time Frame
3 months
Title
Brantigan classification
Description
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).
Time Frame
6 months
Title
Brantigan classification
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Re-operation rate
Description
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Time Frame
At baseline (day 0)
Title
Re-operation rate
Description
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Time Frame
1 month
Title
Re-operation rate
Description
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Time Frame
3 month
Title
Re-operation rate
Description
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Time Frame
6 month
Title
Re-operation rate
Description
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Time Frame
12 month
Title
Visual Analogue Score
Description
Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)
Time Frame
At baseline (day 0)
Title
Visual Analogue Score
Description
Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)
Time Frame
1 month
Title
Visual Analogue Score
Description
Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)
Time Frame
3 months
Title
Visual Analogue Score
Description
Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)
Time Frame
6 months
Title
Visual Analogue Score
Description
Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)
Time Frame
12 months
Title
Oswestry Disability Index
Description
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Time Frame
At baseline (day 0)
Title
Oswestry Disability Index
Description
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Time Frame
1 month
Title
Oswestry Disability Index
Description
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Time Frame
3 months
Title
Oswestry Disability Index
Description
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Time Frame
6 months
Title
Oswestry Disability Index
Description
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Time Frame
12 months
Title
Short Form Health Survey 36
Description
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Time Frame
At baseline (day 0)
Title
Short Form Health Survey 36
Description
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Time Frame
1 month
Title
Short Form Health Survey 36
Description
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Time Frame
3 months
Title
Short Form Health Survey 36
Description
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Time Frame
6 months
Title
Short Form Health Survey 36
Description
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Salamanna, PhD
Phone
+390516366004
Email
francesca.salamanna@ior.it
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Sartori, PhD
Phone
+390516366787
Email
maria.sartori@ior.it
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
State/Province
BO
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Tedesco, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32139727
Citation
Salamanna F, Contartese D, Giavaresi G, Sicuro L, Barbanti Brodano G, Gasbarrini A, Fini M. A Rationale for the Use of Clotted Vertebral Bone Marrow to Aid Tissue Regeneration Following Spinal Surgery. Sci Rep. 2020 Mar 5;10(1):4115. doi: 10.1038/s41598-020-60934-2.
Results Reference
result
PubMed Identifier
28639702
Citation
Salamanna F, Contartese D, Nicoli Aldini N, Barbanti Brodano G, Griffoni C, Gasbarrini A, Fini M. Bone marrow aspirate clot: A technical complication or a smart approach for musculoskeletal tissue regeneration? J Cell Physiol. 2018 Apr;233(4):2723-2732. doi: 10.1002/jcp.26065. Epub 2017 Jul 24.
Results Reference
result
PubMed Identifier
35118056
Citation
Salamanna F, Contartese D, Borsari V, Pagani S, Barbanti Brodano G, Griffoni C, Ricci A, Gasbarrini A, Fini M. Two Hits for Bone Regeneration in Aged Patients: Vertebral Bone Marrow Clot as a Biological Scaffold and Powerful Source of Mesenchymal Stem Cells. Front Bioeng Biotechnol. 2022 Jan 18;9:807679. doi: 10.3389/fbioe.2021.807679. eCollection 2021.
Results Reference
result

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Vertebral Bone Marrow Clot for Spinal Surgery

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