Vertebral Compression FracturesPROTECTNCT06670404
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
An observational study of Vertebral Compression Fractures and Pathological Fracture, run by Prof Nicolas Theumann at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Compression Fractures, Pathological Fracture, Facet Joint Arthropathy
- What is being tested?
- Vertebroplasty
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Nov 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients with vertebral compression fractures from osteoporosis or tumor eligible to be treated with vertebroplasty.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Clinique Bois Cerf
Lausanne
Nicolas Prof Theumann, Medical Doctor, 0041795251859, nicolas.theumann@hirslanden.ch
About this study
Official title: PROTECT - Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
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.
- Being tested
- Vertebroplasty
- Keywords
- vertebroplasty, CONFIDENCE High Viscosity Spinal Cement, observational post-market study
- Medical subject headings
- Fractures, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VertebroplastyDevice
Vertebral compression fractures treated with CONFIDENCE High Viscosity Cement
| Study group | Role | What they receive |
|---|---|---|
| Vertebroplasty cohort | Patients with vertebral compression fractures treated with vertebroplasty Receives: Device: Vertebroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of sagittal balance
measurement of sagittal vertical axis (SVA)
Measured: Up to 12 months post index surgery
Secondary outcomes (3)
Improvement in Back Pain
Measured as NRS scale for back pain
Measured: Up to 12 months post index surgery
Quebec Score
Measured as the standard Quebec Score
Measured: 6-12 months post index surgery
Complications
Measured: Up to 12 months post-index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start6 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Compression FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof Nicolas Theumann
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson, Dr Danoob Dalili
- Responsible party
- Sponsor-investigator, Prof Nicolas Theumann, Hirslanden Clinique Bois-Cerf Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670404
- Sponsor's protocol ID
- THU-2023-010
- Acronym
- PROTECT
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTECT - Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
- ClinicalTrials.gov ID
- NCT06670404
- Acronym / sponsor ID
- PROTECT / THU-2023-010
- Keywords
- vertebroplasty, CONFIDENCE High Viscosity Spinal Cement, observational post-market study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Prof Nicolas TheumannUniversity, hospital or other
- Collaborators
- Johnson & Johnson, Dr Danoob Dalili
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vertebroplasty cohort | – | Device: VertebroplastyPatients with vertebral compression fractures treated with vertebroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients with vertebral compression fractures from osteoporosis or tumor eligible to be treated with vertebroplasty.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VertebroplastyVertebral compression fractures treated with CONFIDENCE High Viscosity Cement | Device | Vertebroplasty cohort |
Primary outcome
Improvement of sagittal balance
Time frame: Up to 12 months post index surgery
measurement of sagittal vertical axis (SVA)
3 secondary outcomes
Improvement in Back Pain
Time frame: Up to 12 months post index surgery
Quebec Score
Time frame: 6-12 months post index surgery
Complications
Time frame: Up to 12 months post-index surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Compression Fractures and Pathological Fracture, run by Prof Nicolas Theumann at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Prof Theumann, Medical Doctor (0041795251859, nicolas.theumann@hirslanden.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of sagittal balance (time frame: Up to 12 months post index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.