Clinical trial NCT05191264: Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases
Official title: Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases: Feasibility, Safety and Early Clinical Outcomes. Monocentric Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interventional Radiology
Keywords: Screw fixation
cementoplasty
interventional radiology
pain management
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with percutaneous osteosynthesis and cementoplasty procedure will be included.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases

Exclusion Criteria:

* patient's refusal to participate

Primary outcomes:
measure: Technical feasibility of the procedure (Yes or No)
timeFrame: Just after the end of the procedure
Secondary outcomes:
measure: Adverse events
timeFrame: Months: 1, 3, 6 and 12
measure: Numerical Rating Scale
timeFrame: Months: 1, 3, 6 and 12
measure: EuroQol 5 Dimensions (EQ5D)
timeFrame: Months: 1, 3, 6 and 12
measure: Consumption of opioids (mg/day)
timeFrame: Months: 1, 3, 6 and 12
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Sylvain GRANGE, MD
role: PRINCIPAL_INVESTIGATOR
References: