Skip to main content
OpenTrials
Completed

NCT Number: NCT05936047

Bone Marrow Clot for Posterior Lumbar Fusion

Bone marrow aspirate (BMA) in association to graft substitutes has long been introduced as a promising alternative to iliac crest bone graft in spinal fusion. However, BMA use is limited by the absence of a standardized technique, of a physical texture and by the possibility of dispersion away from the implant site. Recently, the potential use of a new formulation of BMA, named BMA clot, has been preclinically described. A prospective pilot clinical study designed to assessing the safety and efficacy of autologous vertebral BMA (vBMA) clot as multifunctional bio-scaffold in instrumental posterior lumbar fusion will be performed.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients over the age of 18 at the time of surgery
  • symptomatic degenerative spine disease needing posterior fusion at the lumbar tract

Exclusion criteria

  • any form of local or systemic infections, inflammatory or autoimmune disease
  • coagulation disorders
  • tumor diseases
  • alcohol or drug abuse
  • pregnancy
  • chemotherapeutic drugs that might interfere with bone regeneration processes
  • revision surgery

Treatment and study plan

Vertebral bone marrow clot

Biological

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 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 will be applied on each side of the vertebra according to the number of segments to be fused.

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 FUs, 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: 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 FUs, 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: 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 FUs, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate).

Secondary outcomes

  1. 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)

  2. Visual Analogue Score

    Time frame: 3 months

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

  3. Visual Analogue Score

    Time frame: 12 months

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

  4. 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)

  5. Oswestry Disability Index

    Time frame: 3 months

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

  6. Oswestry Disability Index

    Time frame: 12 months

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

  7. EuroQoL-5L (EQ-5L)

    Time frame: At baseline (day 0)

    EuroQoL-5L (EQ-5L) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)

  8. EuroQoL-5L

    Time frame: 3 months

    EuroQoL-5L (EQ-5L) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)

  9. EuroQoL-5L

    Time frame: 12 months

    EuroQoL-5L (EQ-5L) (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

Efficacy of Autologous Bone Marrow Clot as Scaffold for Instrumental Posterior Lumbar Fusion

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 7, 2023
Registry last updated
Oct 11, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.