Pelvic Ring Tumor LesionsNCT06155890
Restoring Mobility: Roles of Percutaneous Consolidation for Pelvic Ring Bone Lesions
An observational study of Pelvic Ring Tumor Lesions, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Evaluate early functional outcomes following percutaneous screw fixation or cementoplasty for pelvic ring tumor lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Ring Tumor Lesions
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Individuals with cancer who underwent percutaneous screw fixation or cementoplasty either for prophylactic consolidation or treatment of pathologic fractures in pelvic ring tumors.
Who may be able to join
- Individuals with cancer who underwent percutaneous screw fixation or cementoplasty either for prophylactic consolidation or treatment of pathologic fractures in pelvic ring tumors.
Who cannot join
- minors
- incompetent adults
- refused to participate in the study
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoring Mobility: Roles of Percutaneous Consolidation for Pelvic Ring Bone Lesions -a Multicenter Study
Evaluate early functional outcomes following percutaneous screw fixation or cementoplasty for pelvic ring tumor lesions.
- Conditions
- Pelvic Ring Tumor Lesions
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative weight-bearing ambulation
the ability of the patient to walk and bear weight after the procedure and its associated timeframe.
Measured: During hospitalization, mainly less than 3 days
Secondary outcomes (3)
Adverse event
adverse event during procedure or hospitalization
Measured: During hospitalization, and follow-up
Duration of hospitalization
The duration of hospitalization will be measured between the day and time of arrival at the hospital and the day and time of discharge from the hospital
Measured: Mainly less than 3 days
Long-term effectiveness in preventing pathological fractures of the pelvic ring
Absence of pelvic ring fracture during follow-up
Measured: 3 months after the procedure, and during follow-up, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study startJan 2016
- Primary completionSep 2023
- Study completionOct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Ring Tumor LesionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155890
- Sponsor's protocol ID
- 23Imagerie02
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dien E, Stacoffe N, Pavan LJ, Torre F, Ranc PA, Vivarrat-Perrin T, Chalamet B, Pialat JB, Kastler A, Amoretti N. Restoring mobility: roles of percutaneous consolidation for pelvic ring bone lesions-a multicenter study. Eur Radiol. 2025 Jun;35(6):3270-3281. doi: 10.1007/s00330-024-11193-6. Epub 2024 Nov 21.
PubMed 39567430
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Mobility: Roles of Percutaneous Consolidation for Pelvic Ring Bone Lesions -a Multicenter Study
- ClinicalTrials.gov ID
- NCT06155890
- Acronym / sponsor ID
- 23Imagerie02
- Conditions
- Pelvic Ring Tumor Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2023 (actual)
- Study completion
- Oct 2023 (actual)
- First posted
- 5 Dec 2023 (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.
Evaluate early functional outcomes following percutaneous screw fixation or cementoplasty for pelvic ring tumor lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with cancer who underwent percutaneous screw fixation or cementoplasty either for prophylactic consolidation or treatment of pathologic fractures in pelvic ring tumors.
Key inclusion criteria (1 listed)
- Individuals with cancer who underwent percutaneous screw fixation or cementoplasty either for prophylactic consolidation or treatment of pathologic fractures in pelvic ring tumors.
Key exclusion criteria (4 listed)
- minors
- incompetent adults
- refused to participate in the study
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative weight-bearing ambulation
Time frame: During hospitalization, mainly less than 3 days
the ability of the patient to walk and bear weight after the procedure and its associated timeframe.
3 secondary outcomes
Adverse event
Time frame: During hospitalization, and follow-up
Duration of hospitalization
Time frame: Mainly less than 3 days
Long-term effectiveness in preventing pathological fractures of the pelvic ring
Time frame: 3 months after the procedure, and during follow-up, up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Derived from this study: PubMed 39567430Dien E, Stacoffe N, Pavan LJ, Torre F, Ranc PA, Vivarrat-Perrin T, Chalamet B, Pialat JB, Kastler A, Amoretti N. Restoring mobility: roles of percutaneous consolidation for pelvic ring bone lesions-a multicenter study. Eur Radiol. 2025 Jun;35(6):3270-3281. doi: 10.1007/s00330-024-11193-6. Epub 2024 Nov 21.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Pelvic Ring Tumor Lesions, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 3 Dec 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative weight-bearing ambulation (time frame: During hospitalization, mainly less than 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06155890, which also lists 1 linked publication.
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 3 Dec 2024.