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RecruitingNCT06670404PROTECTUpdated Oct 21, 2026

Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures

An observational study in Vertebral Compression Fractures, Pathological Fracture and Facet Joint Arthropathy, sponsored by Prof Nicolas Theumann. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Prof Nicolas Theumann · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 2 years later.
Updated Oct 21, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
130
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Vertebral Compression Fractures
  • Pathological Fracture
  • Facet Joint Arthropathy

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Keywords

  • vertebroplasty
  • CONFIDENCE High Viscosity Spinal Cement
  • observational post-market study
03

In context

Fractures, Spontaneous

27 studies on the registry are indexed under Fractures, Spontaneous; 7 are open to participants now.

This study's planned enrollment of 130 is below the median of 150 across 11 observational studies indexed under Fractures, Spontaneous.

Browse Fractures, Spontaneous studies →

Lead sponsor

This is the only study on the registry with Prof Nicolas Theumann as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No

Groups and cohorts

  • Vertebroplasty cohort

    Patients with vertebral compression fractures treated with vertebroplasty

    Device: Vertebroplasty

Interventions

  • DeviceVertebroplasty

    Vertebral compression fractures treated with CONFIDENCE High Viscosity Cement

06

What researchers measure

Primary outcomes

  1. Improvement of sagittal balance

    measurement of sagittal vertical axis (SVA)

    Time frame: Up to 12 months post index surgery

Secondary outcomes

  1. Improvement in Back Pain

    Measured as NRS scale for back pain

    Time frame: Up to 12 months post index surgery

  2. Quebec Score

    Measured as the standard Quebec Score

    Time frame: 6-12 months post index surgery

  3. Complications

    Time frame: Up to 12 months post-index surgery

07

Study locations

1 of 1 sites recruiting
  • Clinique Bois Cerf
    Lausanne, Switzerland
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Dec 31, 2026→Dec 31, 2027
Oct 21, 2026
Study completion
Dec 31, 2026→Dec 31, 2027
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    Primary completion Dec 31, 2026→Dec 31, 2027
    Study completion Dec 31, 2026→Dec 31, 2027
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06670404
Lead sponsor
Prof Nicolas Theumann
Collaborators
Johnson & Johnson, Dr Danoob Dalili
Responsible party
Prof Nicolas Theumann (Professor, Hirslanden Clinique Bois-Cerf Lausanne) — Sponsor-investigator
First posted
Nov 1, 2024
Start date
Nov 6, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

Nicolas Prof Theumann, Medical Doctor
Contact
nicolas.theumann@hirslanden.ch
0041795251859

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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