Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases

Interventional Radiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05191264
• Other study ID #: IRBN942019/CHUSTE
• Status: Recruiting
• Start date: July 10, 2019
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Sylvain GRANGE, MD
• Phone: (0)477829066
• Email: Sylvain.Grange[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases

Exclusion Criteria:

• patient's refusal to participate

Related Conditions & MeSH terms

• Interventional Radiology
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical feasibility of the procedure (Yes or No)	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	Just after the end of the procedure
Secondary	Adverse events	To confirm the safety of the procedure, all adverse events related to the procedure are screened and reported	Months: 1, 3, 6 and 12
Secondary	Numerical Rating Scale	Numerical Rating Scale (NRS) evaluates the pain. This scale starts from 0 (no pain) to 10 (maximal pain)	Months: 1, 3, 6 and 12
Secondary	EuroQol 5 Dimensions (EQ5D)	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	Months: 1, 3, 6 and 12
Secondary	Consumption of opioids (mg/day)		Months: 1, 3, 6 and 12