Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases

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

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.

Study Overview

• Status: Recruiting
• Conditions: Interventional Radiology
• Intervention / Treatment: Other: EQ5D (EuroQol 5 Dimensions); Other: Numerical Rating Scale (NRS); Other: evaluated the consumption of analgesics

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Sylvain GRANGE, MD; Phone Number: +33 (0)477829066; Email: Sylvain.Grange@chu-st-etienne.fr
• Study Contact Backup: Name: Sylvain BERTHOLON, resident; Phone Number: +33 (0)477829066; Email: Sylvain.Grange@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France
    • Recruiting
    • Chu Saint-Etienne
    • Principal Investigator: Sylvain GRANGE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with percutaneous osteosynthesis and cementoplasty procedure will be included.

Description

Inclusion Criteria:

• patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases

Exclusion Criteria:

• patient's refusal to participate

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

percutaneous osteosynthesis and cementoplasty procedure; 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.

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).; Other Names: evaluation of the quality of life; Other: 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).; Other Names: evaluation of the type and intensity of pain; Other: evaluated the consumption of analgesics; the consumption of analgesics by step and by dosage will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Consumption of opioids (mg/day)		Months: 1, 3, 6 and 12

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Sylvain GRANGE, MD, Chu Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: interventional radiology; pain management; Screw fixation; cementoplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: IRBN942019/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No