Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases

Официальное название

Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases: Feasibility, Safety and Early Clinical Outcomes. Monocentric Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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).
• Другое 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).
• Другое evaluated the consumption of analgesics
  the consumption of analgesics by step and by dosage will be evaluated.

Первичные конечные точки

• Technical feasibility of the procedure (Yes or No) [Срок оценки: Just after the end of the procedure]

Вторичные конечные точки (4)

• Adverse events [Срок оценки: Months: 1, 3, 6 and 12]
• Numerical Rating Scale [Срок оценки: Months: 1, 3, 6 and 12]
• EuroQol 5 Dimensions (EQ5D) [Срок оценки: Months: 1, 3, 6 and 12]
• Consumption of opioids (mg/day) [Срок оценки: Months: 1, 3, 6 and 12]

Критерии участия

Критерии включения

• patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases

Критерии исключения

• patient's refusal to participate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• CHU Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT05191264 · IRBN942019/CHUSTE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗