Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Interventional Radiology

Treatments: Other: evaluated the consumption of analgesics; Other: EQ5D (EuroQol 5 Dimensions); Other: Numerical Rating Scale (NRS)

Study type: Observational

Funder types: Other

Identifiers

NCT05191264

IRBN942019/CHUSTE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases

Exclusion criteria

• patient's refusal to participate

Trial design

150 participants in 1 patient group

percutaneous osteosynthesis and cementoplasty procedure

Description:

Patient with percutaneous osteosynthesis and cementoplasty procedure will be included. Patients have assessed for pain and quality of life during consultations as part of an interventional radiology procedure (pre-procedure consultation, and follow-up consultations at 1, 3, 6 and 12 months after the procedure.

Treatment:

Other: Numerical Rating Scale (NRS)

Other: EQ5D (EuroQol 5 Dimensions)

Other: evaluated the consumption of analgesics