Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EQ5D (EuroQol 5 Dimensions), Numerical Rating Scale (NRS), evaluated the consumption of analgesics.
- Who it may be relevant to
- Registry conditions: Interventional Radiology. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases: Feasibility, Safety and Early Clinical Outcomes. Monocentric Study
Overview
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.
Interventions
- Other EQ5D (EuroQol 5 Dimensions)
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). - Other Numerical Rating Scale (NRS)
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). - Other evaluated the consumption of analgesics
the consumption of analgesics by step and by dosage will be evaluated.
Primary outcome measures
- Technical feasibility of the procedure (Yes or No) [Time frame: Just after the end of the procedure]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases
Exclusion criteria
- patient's refusal to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU Saint-Etienne — Saint-Etienne
Identifiers
NCT: NCT05191264 · IRBN942019/CHUSTE