Interventional RadiologyNCT05191264
Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases
An observational study of Interventional Radiology, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
In oncology, therapeutic progress has allowed a significant increase in life-expectancy: a growing number of cancer survivors live to more advanced metastatic stages. Consequently, the prevalence of secondary bone lesions is increasing, which are frequent and disabling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interventional Radiology
- What is being tested?
- EQ5D (EuroQol 5 Dimensions), Numerical Rating Scale (NRS) and evaluated the consumption of analgesics
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2019to Jun 2026
- 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: Patient with percutaneous osteosynthesis and cementoplasty procedure will be included.
Who may be able to join
- patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases
Who cannot join
- patient's refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Saint-Etienne
Saint-Etienne
Sylvain GRANGE, MD
About this study
Official title: Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases: Feasibility, Safety and Early Clinical Outcomes. Monocentric Study
In oncology, therapeutic progress has allowed a significant increase in life-expectancy: a growing number of cancer survivors live to more advanced metastatic stages. Consequently, the prevalence of secondary bone lesions is increasing, which are frequent and disabling. They are responsible for pain and a high risk of pathological fractures. The average prevalence of pain in cancer represents 53% for all stages combined and 64% for metastatic stages.
Analgesics, radiotherapy and surgery are widely used in this context, but are not without side effects.
Read more
Cementoplasty is an interventional radiology procedure that has improved the palliative management of bone lesions. It consists of a percutaneous injection of polymethylmethacrylate-based cement, whose physical and chemical properties provide resistance to compressive stress during weight-bearing activities. However, one of the main disadvantages of cement is its low resistance to torsional stress, as evidenced notably in vitro tests. Thus, cementoplasty alone is very effective at the spinal level (compressive forces) to reduce pain and risk of fracture, but much less effective at the level of other bones that are subjected to torsional stresses, notably the pelvis and femur (40% fracture rate at one year after cementoplasty alone of femoral metastasis).
Fixation using a combination of metal screws and cement provides resistance to torsional and compressive stress. In addition, it has been shown that there is a significant risk of secondary screw displacement if screws are not combined with cement in secondary bone lesions. Combination of percutaneous screw fixation and cementoplasty is a mini-invasive procedure which allows limiting complications and the duration of treatment: early standing up, almost no blood loss, reduced risk of venous thromboembolism (VTE), rapid healing.
Read the detailed description
The aim of this prospective study is to evaluate feasibility, safety, and efficacy of combination of percutaneous screw fixation and cementoplasty for lytic bone metastases.
- Conditions
- Interventional Radiology
- Being tested
- EQ5D (EuroQol 5 Dimensions), Numerical Rating Scale (NRS), evaluated the consumption of analgesics
- Keywords
- Screw fixation, cementoplasty, interventional radiology, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQ5D (EuroQol 5 Dimensions)Other
Also called evaluation of the quality of life
The evaluation of the quality of life was conducted with the EQ5D (EuroQol 5 Dimensions) score (min 0: bad health and max:100 good health).
Numerical Rating Scale (NRS)Other
Also called evaluation of the type and intensity of pain
the type and intensity of pain will be evaluated by Numerical Rating Scale (NRS) from 0 to 10 in different positions and in different activities (e.g. background pain, general maximum/minimum pain, pain of the site treated by the procedure, pain at rest, in lying position, in sitting position, in standing position, at bearing weight, in walking, description of painful irradiations, nocturnal awakenings).
evaluated the consumption of analgesicsOther
the consumption of analgesics by step and by dosage will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| percutaneous osteosynthesis and cementoplasty procedure | Patient with percutaneous osteosynthesis and cementoplasty procedure will be included.
Patients have assessed for pain and quality of life during consultations as part of an interventional radiology procedure (pre-procedure consultation, and follow-up consultations at 1, 3, 6 and 12 months after the procedure. Receives: Other: EQ5D (EuroQol 5 Dimensions); Other: Numerical Rating Scale (NRS); Other: evaluated the consumption of analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical feasibility of the procedure (Yes or No)
The technical success of the procedure is defined as (all criteria have to be fulfilled) :
- the correct placement of the screw(s),
- any complication as major cement leakage such as intra-articular or intra-vascular leakage, abundant bleeding, vascular or nervous lesion, displacement of bone fragment
Theses criteria are measured on CT-scan
Measured: Just after the end of the procedure
Secondary outcomes (4)
Adverse events
To confirm the safety of the procedure, all adverse events related to the procedure are screened and reported
Measured: Months: 1, 3, 6 and 12
Numerical Rating Scale
Numerical Rating Scale (NRS) evaluates the pain. This scale starts from 0 (no pain) to 10 (maximal pain)
Measured: Months: 1, 3, 6 and 12
EuroQol 5 Dimensions (EQ5D)
EQ5D evaluates the quality of life.. Patients are asked to describe their own health and also provide a self-rating on a 20-cm vertical scale with endpoints of 'best imaginable health state' set at 100 and 'worst imaginable health state' set at 0
Measured: Months: 1, 3, 6 and 12
Consumption of opioids (mg/day)
Measured: Months: 1, 3, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start10 Jul 2019
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interventional RadiologyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain GRANGE, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191264
- Sponsor's protocol ID
- IRBN942019/CHUSTE
- Status last verified
- Mar 2025
- First submitted
- 29 Dec 2021
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases: Feasibility, Safety and Early Clinical Outcomes. Monocentric Study
- ClinicalTrials.gov ID
- NCT05191264
- Acronym / sponsor ID
- IRBN942019/CHUSTE
- Conditions
- Interventional Radiology
- Keywords
- Screw fixation, cementoplasty, interventional radiology, pain management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Jan 2022 (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.
In oncology, therapeutic progress has allowed a significant increase in life-expectancy: a growing number of cancer survivors live to more advanced metastatic stages. Consequently, the prevalence of secondary bone lesions is increasing, which are frequent and disabling. They are responsible for pain and a high risk of pathological fractures. The average prevalence of pain in cancer represents 53% for all stages combined and 64% for metastatic stages.
Analgesics, radiotherapy and surgery are widely used in this context, but are not without side effects.
Cementoplasty is an interventional radiology procedure that has improved the palliative management of bone lesions. It consists of a percutaneous injection of polymethylmethacrylate-based cement, whose physical and chemical properties provide resistance to compressive stress during weight-bearing activities. However, one of the main disadvantages of cement is its low resistance to torsional stress, as evidenced notably in vitro tests. Thus, cementoplasty alone is very effective at the spinal level (compressive forces) to reduce pain and risk of fracture, but much less effective at the level of other bones that are subjected to torsional stresses, notably the pelvis and femur (40% fracture rate at one year after cementoplasty alone of femoral metastasis).
Fixation using a combination of metal screws and cement provides resistance to torsional and compressive stress. In addition, it has been shown that there is a significant risk of secondary screw displacement if screws are not combined with cement in secondary bone lesions. Combination of percutaneous screw fixation and cementoplasty is a mini-invasive procedure which allows limiting complications and the duration of treatment: early standing up, almost no blood loss, reduced risk of venous thromboembolism (VTE), rapid healing.
Detailed description
The aim of this prospective study is to evaluate feasibility, safety, and efficacy of combination of percutaneous screw fixation and cementoplasty for lytic bone metastases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| percutaneous osteosynthesis and cementoplasty procedure | – | Other: EQ5D (EuroQol 5 Dimensions), Other: Numerical Rating Scale (NRS), Other: evaluated the consumption of analgesicsPatient with percutaneous osteosynthesis and cementoplasty procedure will be included. Patients have assessed for pain and quality of life during consultations as part of an interventional radiology procedure (pre-procedure consultation, and follow-up consultations at 1, 3, 6 and 12 months after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with percutaneous osteosynthesis and cementoplasty procedure will be included.
Key inclusion criteria (1 listed)
- patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases
Key exclusion criteria (1 listed)
- patient's refusal to participate
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 |
|---|---|---|
| EQ5D (EuroQol 5 Dimensions)Also: evaluation of the quality of lifeThe evaluation of the quality of life was conducted with the EQ5D (EuroQol 5 Dimensions) score (min 0: bad health and max:100 good health). | Other | percutaneous osteosynthesis and cementoplasty procedure |
| Numerical Rating Scale (NRS)Also: evaluation of the type and intensity of painthe type and intensity of pain will be evaluated by Numerical Rating Scale (NRS) from 0 to 10 in different positions and in different activities (e.g. background pain, general maximum/minimum pain, pain of the site treated by the procedure, pain at rest, in lying position, in sitting position, in standing position, at bearing weight, in walking, description of painful irradiations, nocturnal awakenings). | Other | percutaneous osteosynthesis and cementoplasty procedure |
| evaluated the consumption of analgesicsthe consumption of analgesics by step and by dosage will be evaluated. | Other | percutaneous osteosynthesis and cementoplasty procedure |
Primary outcome
Technical feasibility of the procedure (Yes or No)
Time frame: Just after the end of the procedure
The technical success of the procedure is defined as (all criteria have to be fulfilled) : * the correct placement of the screw(s), * any complication as major cement leakage such as intra-articular or intra-vascular leakage, abundant bleeding, vascular or nervous lesion, displacement of bone fragment Theses criteria are measured on CT-scan
4 secondary outcomes
Adverse events
Time frame: Months: 1, 3, 6 and 12
Numerical Rating Scale
Time frame: Months: 1, 3, 6 and 12
EuroQol 5 Dimensions (EQ5D)
Time frame: Months: 1, 3, 6 and 12
Consumption of opioids (mg/day)
Time frame: Months: 1, 3, 6 and 12
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 18 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Sylvain GRANGE, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Interventional Radiology, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 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 18 Mar 2025. 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?
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 Sylvain GRANGE, MD ((0)477829066 ext. +33, Sylvain.Grange@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical feasibility of the procedure (Yes or No) (time frame: Just after the end of the procedure). 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 18 Mar 2025.