CHU Saint-Etienne
Saint-Etienne, France
Location status: Recruiting
Location contact
Sylvain GRANGE, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05191264
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Saint-Etienne, France
Location status: Recruiting
Sylvain GRANGE, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: evaluation of the quality of life
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 names: evaluation of the type and intensity of pain
the consumption of analgesics by step and by dosage will be evaluated.
Time frame: Just after the end of the procedure
The technical success of the procedure is defined as (all criteria have to be fulfilled) :
Theses criteria are measured on CT-scan
Time frame: Months: 1, 3, 6 and 12
To confirm the safety of the procedure, all adverse events related to the procedure are screened and reported
Time frame: Months: 1, 3, 6 and 12
Numerical Rating Scale (NRS) evaluates the pain. This scale starts from 0 (no pain) to 10 (maximal pain)
Time frame: Months: 1, 3, 6 and 12
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
Time frame: Months: 1, 3, 6 and 12
Contact information is provided by the study sponsor or research team.
Sylvain BERTHOLON, resident
CONTACT
(0)477829066 ext. +33
Sylvain GRANGE, MD
CONTACT
(0)477829066 ext. +33
Centre Hospitalier Universitaire de Saint Etienne
Other
Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases: Feasibility, Safety and Early Clinical Outcomes. Monocentric Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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