Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases

Last updated: March 17, 2025
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Treatment

EQ5D (EuroQol 5 Dimensions)

evaluated the consumption of analgesics

Numerical Rating Scale (NRS)

Clinical Study ID

NCT05191264
IRBN942019/CHUSTE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases

Exclusion

Exclusion Criteria:

  • patient's refusal to participate

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: EQ5D (EuroQol 5 Dimensions)
Phase:
Study Start date:
July 10, 2019
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • CHU Saint-Etienne

    Saint-Étienne,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.