Combining screw fixation and cement injection for bone metastases
Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases: Feasibility, Safety and Early Clinical Outcomes. Monocentric Study
This study is testing if combining screw fixation with cement injection can help people with painful bone metastases manage their pain better and reduce the chance of fractures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Etienne) |
| Trial ID | NCT05191264 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility, safety, and efficacy of combining percutaneous screw fixation with cementoplasty for patients suffering from lytic bone metastases. As cancer survivors increasingly face advanced metastatic stages, the prevalence of painful secondary bone lesions rises, necessitating improved palliative care strategies. The study will assess patient outcomes using tools like the EuroQol 5 Dimensions (EQ5D) and Numerical Rating Scale (NRS) to measure pain and analgesic consumption. By exploring this combination approach, the study seeks to enhance pain management and reduce the risk of pathological fractures.
Who should consider this trial
Good fit: Ideal candidates include patients who have undergone osteosynthesis or cementoplasty for lytic bone metastases.
Not a fit: Patients who refuse to participate in the study will not receive any benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and quality of life for patients with lytic bone metastases.
How similar studies have performed: While similar approaches have been explored, this specific combination of techniques is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases Exclusion Criteria: * patient's refusal to participate
Where this trial is running
Saint-Etienne
- CHU Saint-Etienne — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Sylvain GRANGE, MD — Centre Hospitalier Universitaire de Saint Etienne
- Study coordinator: Sylvain GRANGE, MD
- Email: Sylvain.Grange@chu-st-etienne.fr
- Phone: (0)477829066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.