NCT05815251

Brief Summary

Study is a prospective observational, performed in the context of normal clinical practice, of patients with osteoporotic vertebral compression fractures identified as candidates for kyphoplasty treatment with porous trabecular titanium microspheres (see whether to put commercial name and company). The study does not involve any interference with the patient's diagnostic-therapeutic course The objective of the study is the clinical-radiological evaluation of the efficacy of kyphoplasty treatment with trabecular porous titanium spheres in terms of pain control and reduction of kyphotic deformity following fracture. Further evaluation of the safety of the treatment in terms of absence of intraoperative adverse events and material-related toxicity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

February 24, 2023

Last Update Submit

April 19, 2023

Conditions

Vertebral FractureKyphoplasty

Keywords

osteoporotic fracturevertebral augmentationvertebral compression fracture

Outcome Measures

Primary Outcomes (2)

  • Disability index

    Evaluation of the effectiveness of treatment on reducing disability secondary to the occurrence of osteoporotic compression fracture. The used scale is: Oswestry Disability Index (ODI) The effectiveness of the therapy used was tested by considering the ODI expressed (from 0 to 50) in numerical value before ("pre" condition) and after ("post" condition) kyphoplasty treatment as the observed quantity.

    1 year

  • Patients with Pain improvement

    Evaluation of the effectiveness of treatment on reducing pain after the treatment. The used scale is Back Pain Visual Analogue Scale (VAS) from 0 (no pain) to 10 (maximum pain). The effectiveness of the therapy used was tested by considering VAS scale expressed in numerical value before ("pre" condition) and after ("post" condition) kyphoplasty treatment as the observed quantity.

    1 year

Secondary Outcomes (3)

  • Percentage of patients with side effects

    1 year

  • Rate of Kyphosis recovery

    3 months

  • Rate of patients with dislocation of the sphere

    1 year

Study Arms (1)

Sphereplast group

Patients with osteoporotic vertebral compression fractures identified as candidates for kyphoplasty treatment with porous trabecular titanium microspheres

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with documented presence of vertebral compression fracture/osteoporotic collapse. Osteoporosis is the most frequent bone disease with high incidence in the population over 55 years of age. The occurrence of vertebral compression fractures is very common in patients with osteoporosis either in association with minor trauma or as a spontaneous event.

You may qualify if:

  • Presence of osteoporotic vertebral fracture occurred within the previous 6 weeks and documented by CT, MRI, or X-ray in relation to the diagnostic pathway the patient underwent
  • Patients with fractures according to AO Spine-DGOU OF2, OF3 and OF4 classification are enrollable limited to cases in which soma height loss is less than 60% and in the absence of vertical split type pincer fracture.
  • Diagnosis of osteoporosis preceding or concurrent with fracture occurrence, regardless of current therapy
  • Availability of adequate preoperative radiologic documentation: CT or MRI of the lumbar spine; RX required for evaluation of kyphosis.
  • Availability of adequate and comprehensive clinical information including presence of ODI score, MRQ, VAS.

You may not qualify if:

  • Presence of oncologic, metabolic, or endocrinologic diseases related to bone fragility
  • Age \< 55 years
  • Previous treatment of arthrodesis, vertebroplasty, or percutaneous kyphoplasty for previous fractures
  • Presence of neurological deficits in the lower limbs medullary or radicular prior to fracture occurrence
  • Unavailability for follow-up for at least 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli studi di Torino

Turin, 10126, Italy

RECRUITING

Related Publications (10)

  • Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.

    PMID: 30560029BACKGROUND

  • Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.

    PMID: 30074971BACKGROUND

  • Makino T, Kaito T, Fujiwara H, Honda H, Sakai Y, Takenaka S, Yoshikawa H, Yonenobu K. Risk Factors for Poor Patient-Reported Quality of Life Outcomes After Posterior Lumbar Interbody Fusion: An Analysis of 2-Year Follow-up. Spine (Phila Pa 1976). 2017 Oct 1;42(19):1502-1510. doi: 10.1097/BRS.0000000000002137.

    PMID: 28248893BACKGROUND

  • Kaiser MG, Eck JC, Groff MW, Watters WC 3rd, Dailey AT, Resnick DK, Choudhri TF, Sharan A, Wang JC, Mummaneni PV, Dhall SS, Ghogawala Z. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 1: introduction and methodology. J Neurosurg Spine. 2014 Jul;21(1):2-6. doi: 10.3171/2014.4.SPINE14257.

    PMID: 24980578BACKGROUND

  • Costa F, Anania CD, Zileli M, Servadei F, Fornari M. Lumbar Spinal Stenosis: Introduction to the World Federation of Neurosurgical Societies (WFNS) Spine Committee Recommendations. World Neurosurg X. 2020 Mar 10;7:100075. doi: 10.1016/j.wnsx.2020.100075. eCollection 2020 Jul.

    PMID: 32613188BACKGROUND

  • Eck JC, Sharan A, Ghogawala Z, Resnick DK, Watters WC 3rd, Mummaneni PV, Dailey AT, Choudhri TF, Groff MW, Wang JC, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 7: lumbar fusion for intractable low-back pain without stenosis or spondylolisthesis. J Neurosurg Spine. 2014 Jul;21(1):42-7. doi: 10.3171/2014.4.SPINE14270.

    PMID: 24980584BACKGROUND

  • Wang JC, Dailey AT, Mummaneni PV, Ghogawala Z, Resnick DK, Watters WC 3rd, Groff MW, Choudhri TF, Eck JC, Sharan A, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: lumbar fusion for disc herniation and radiculopathy. J Neurosurg Spine. 2014 Jul;21(1):48-53. doi: 10.3171/2014.4.SPINE14271.

    PMID: 24980585BACKGROUND

  • Resnick DK, Watters WC 3rd, Sharan A, Mummaneni PV, Dailey AT, Wang JC, Choudhri TF, Eck J, Ghogawala Z, Groff MW, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 9: lumbar fusion for stenosis with spondylolisthesis. J Neurosurg Spine. 2014 Jul;21(1):54-61. doi: 10.3171/2014.4.SPINE14274.

    PMID: 24980586BACKGROUND

  • Resnick DK, Watters WC 3rd, Mummaneni PV, Dailey AT, Choudhri TF, Eck JC, Sharan A, Groff MW, Wang JC, Ghogawala Z, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: lumbar fusion for stenosis without spondylolisthesis. J Neurosurg Spine. 2014 Jul;21(1):62-6. doi: 10.3171/2014.4.SPINE14275.

    PMID: 24980587BACKGROUND

  • Groff MW, Dailey AT, Ghogawala Z, Resnick DK, Watters WC 3rd, Mummaneni PV, Choudhri TF, Eck JC, Sharan A, Wang JC, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 12: pedicle screw fixation as an adjunct to posterolateral fusion. J Neurosurg Spine. 2014 Jul;21(1):75-8. doi: 10.3171/2014.4.SPINE14277.

    PMID: 24980589BACKGROUND

MeSH Terms

Conditions

Spinal FracturesOsteoporotic Fractures

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Central Study Contacts

Fulvio Tartara, M.D.

CONTACT

+39 3356847079tartarafulvio@gmail.com

Fabio Cofano, M.D.

CONTACT

+39 33313441404fabio.cofano@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Researcher, Neurosurgeon

Study Record Dates

First Submitted

February 24, 2023

First Posted

April 18, 2023

Study Start

January 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations

IT(1)