NCT02700308

Brief Summary

Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture. The main adverse event related to vertebroplasty use is the cement leakages that might be responsible for significant clinical impairments. Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on balloon through the needle into the targeted vertebrae and then inflation of the balloon prior to cement injection into the space. In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage. To date, no data from randomized study are available in the population of cancer patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

4.8 years

First QC Date

October 27, 2015

Last Update Submit

July 26, 2022

Conditions

Solid TumorsSpine Metastasis

Keywords

Solid tumorsSpine metastasisVertebroplastykyphoplastyrandomization

Outcome Measures

Primary Outcomes (1)

  • Success rate for each strategy

    The success rate will be calculated with the proportion of patients without cement leakage

    3 months after the procedure

Secondary Outcomes (13)

  • Height of the targeted vertebrae

    3 months after the procedure

  • Height of the patient

    3 months after the procedure

  • Kyphotic angle

    3 months after the procedure

  • Analgesic properties of the strategies the day after the procedure

    The day after the procedure

  • Analgesic properties of the strategies at 21 days

    21 days after the procedure

  • +8 more secondary outcomes

Study Arms (2)

Conventional vertebroplasty

ACTIVE COMPARATOR

Conventional vertebroplasty (device's trade at the discretion of the investigator)

Device: Conventional vertebroplasty

Kyphoplasty

EXPERIMENTAL

Vertebroplasty with balloon placement and inflation prior to cement injection (device's trade at the discretion of the investigator)

Device: Kyphoplasty

Interventions

KyphoplastyDEVICE

Placement and inflation of balloon prior to cement injection

Also known as: Balloon kyphoplasty
Kyphoplasty
Conventional vertebroplastyDEVICE

Conventional vertebroplasty

Also known as: Vertebroplasty
Conventional vertebroplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of cancer other than malignant hemopathies, myeloma, brain tumors, germ-cell tumors and bone sarcomas;
  • metastatic sites or more;
  • Spine metastasis between T1 and L5 with reduction of vertebrae of 20% at least;
  • Indication of cementoplasty of 1 to 6 vertebrae defined by 1 of the following:
  • Pain equal or greater than 4/10 at Visual Analogic Scale
  • Unstable vertebrae (SINS score equal or greater than 7;
  • Performance Status of the Eastern Cooperative Oncology Group : 0, 1 or 2

You may not qualify if:

  • Contraindication to vertebroplasty, including contraindication to cement use;
  • Patient already treated by vertebroplasty within the past 3 months (1 patient can not be allocated twice in this study);
  • Previous focal treatment of the targeted vertebrae (vertebroplasty, percutaneous radiofrequency, embolization);
  • Neurological deficit due to medullar or radicular compression;
  • Participation to another clinical trial with an analgesic intent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Léon Bérard

Lyon, 69008, France

Location

Hopital Nord

Saint-Etienne, 42270, France

Location

MeSH Terms

Interventions

KyphoplastyVertebroplasty

Intervention Hierarchy (Ancestors)

CementoplastyOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Amine BOUHAMAMA, MD

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2015

First Posted

March 7, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)