Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases

NCT05191264 | Recruiting

• 1 other identifier: IRBN942019/CHUSTE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interventional Radiology

Keywords

Screw fixation; cementoplasty; interventional radiology; pain management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adverse events

  Months: 1, 3, 6 and 12

• Numerical Rating Scale

  Months: 1, 3, 6 and 12

• EuroQol 5 Dimensions (EQ5D)

  Months: 1, 3, 6 and 12

• Consumption of opioids (mg/day)

  Months: 1, 3, 6 and 12

Study Arms (1)

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); Other: Numerical Rating Scale (NRS); Other: evaluated the consumption of analgesics

Interventions

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).

Also known as: evaluation of the quality of life

percutaneous osteosynthesis and cementoplasty procedure

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).

Also known as: evaluation of the type and intensity of pain

percutaneous osteosynthesis and cementoplasty procedure

evaluated the consumption of analgesics OTHER

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

percutaneous osteosynthesis and cementoplasty procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with percutaneous osteosynthesis and cementoplasty procedure will be included.

You may qualify if:

• patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases

You may not qualify if:

• patient's refusal to participate

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sylvain GRANGE, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain GRANGE, MD

CONTACT

(0)477829066; Sylvain.Grange@chu-st-etienne.fr

Sylvain BERTHOLON, resident

CONTACT

(0)477829066; Sylvain.Grange@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 13, 2022
• Study Start: July 10, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)