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NCT Number: NCT05191264

Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

Location status: Recruiting

Location contact

Sylvain GRANGE, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases

Exclusion criteria

  • patient's refusal to participate

Treatment and study plan

EQ5D (EuroQol 5 Dimensions)

Other

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

Numerical rating scale (NRS)

Other

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

evaluated the consumption of analgesics

Other

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

Primary outcomes

  1. Technical feasibility of the procedure (Yes or No)

    Time frame: Just after the end of the procedure

    The technical success of the procedure is defined as (all criteria have to be fulfilled) :

    • the correct placement of the screw(s),
    • any complication as major cement leakage such as intra-articular or intra-vascular leakage, abundant bleeding, vascular or nervous lesion, displacement of bone fragment

    Theses criteria are measured on CT-scan

Secondary outcomes

  1. Adverse events

    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

  2. Numerical Rating Scale

    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)

  3. EuroQol 5 Dimensions (EQ5D)

    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

  4. Consumption of opioids (mg/day)

    Time frame: Months: 1, 3, 6 and 12

Study contacts

Contact information is provided by the study sponsor or research team.

Sylvain BERTHOLON, resident

CONTACT

[email protected]

(0)477829066 ext. +33

Sylvain GRANGE, MD

CONTACT

[email protected]

(0)477829066 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2022
Registry last updated
Mar 18, 2025

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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