Prospective Evaluation of Therapeutic Combination in Trea... | NCT06670404

Studies
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures

NCT06670404

Sponsor

Prof Nicolas Theumann

Status

Recruiting

Last Update Posted

Feb 17, 2025Actual

Enrollment

130Estimated

Phase

Not provided

Conditions

Vertebral Compression Fractures
Pathological Fracture
Facet Joint Arthropathy

Interventions

Vertebroplasty

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2024Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Oct 31, 2024

First Submission Date that Met QC Criteria

Oct 31, 2024

First Posted Date

Nov 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2025

Last Update Posted Date

Feb 17, 2025Actual

Name	Class
Johnson & Johnson	INDUSTRY
Dr Danoob Dalili	UNKNOWN

Description Module

Brief Summary

The purpose of this study is to collect clinical and radiographic outcomes in patients undergoing vertebroplasty procedures for the treatment of osteoporotic or pathological fractures of the vertebral body to understand the role of sagittal balance in patient outcomes. To support this objective, the sagittal balance measurement of sagittal vertical axis (SVA), NRS back pain, Quebec Back Pain Disability Scale (Quebec) score, and complications will be collected. The secondary purpose of the study is to review the role of sagittal balance and adjacent facet joint arthropathy treatment in patients with vertebral body fractures due to osteoporosis or tumor.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vertebroplasty cohort		Patients with vertebral compression fractures treated with vertebroplasty	Device: Vertebroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vertebroplasty	Device	Vertebral compression fractures treated with CONFIDENCE High Viscosity Cement	Vertebroplasty cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of sagittal balance	measurement of sagittal vertical axis (SVA)	Up to 12 months post index surgery

Secondary Outcomes

Measure	Description	Time Frame
Improvement in Back Pain	Measured as NRS scale for back pain	Up to 12 months post index surgery
Quebec Score	Measured as the standard Quebec Score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients >18 years.
Patients requiring vertebroplasty for the fixation of symptomatic pathological fractures of the thoracic or lumbar vertebral body resulting from osteoporosis or tumor.
Symptomatic vertebral compression fracture(s) confirmed by MRI with bone marrow oedema on T2/STIR sequences.
Diagnosis of osteoporosis (clinically and confirmed on DXA with quantifiable BMD) or pathological fracture due to tumor
Patients with 1 or more vertebral compression fractures of the thoracic or lumbar spine Note: Patients with a current vertebral compression fracture who also have a previous history of vertebral compression fractures of the thoracic or lumbar spine may be included.

Study Specific Inclusion Criterion • Signed informed consent

Exclusion Criteria:

Infection
Vertebral body collapse to less than 1/3 (33%) of original height
Vertebral plana (>90% vertebral body collapse)
Spinal stenosis (retro pulsed fragments).
Unstable spine warranting surgical stabilization
Prophylactic treatment of any vertebrae with vertebroplasty
Irreversible life threating bleeding disorders
End stage kidney disease
Drug dependence (IVDU)
Pregnancy

Study Specific Exclusion Criterion:

• Unable or unwilling to follow the standard of care prescribed follow-up visits

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Male and female patients with vertebral compression fractures from osteoporosis or tumor eligible to be treated with vertebroplasty.

Sampling Method

Non-Probability Sample

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries

ID	Term
D060826	Cementoplasty
D019637	Orthopedic Procedures
D013812	Therapeutics
D013514	Surgical Procedures, Operative