NCT03620305

Brief Summary

Description of septic pseudarthrosis with chirurgical treatment in two steps (first step : Implementation of cement, second step : bone reconstruction, with or without device)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

July 27, 2018

Last Update Submit

February 15, 2019

Conditions

Pseudoarthrosis of Bone

Outcome Measures

Primary Outcomes (1)

  • Description of treatment of septic pseudarthrosis : chirurgical treatment - rate of use of this type of chirurgical treatment among patients with septic pseudarthrosis

    Description of treatment of septic pseudarthrosis : chirurgical treatment

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Secondary Outcomes (2)

  • Description of treatment of septic pseudarthrosis : medical treatment - duration of treatment in patients having sepstic pseudarthrosis

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

  • Treatment failure : rate of failure with this 2 times chirurgical treatment

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Study Arms (1)

Description of treatment of septic pseudarthrosis

chirurgical and medical treatment

Other: Description of treatment of septic pseudarthrosis

Interventions

Description of treatment of septic pseudarthrosisOTHER

description of chirurgical 2 steps management of septic pseudarthrosis

Description of treatment of septic pseudarthrosis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

: patients having septic pseudarthrosis managed with 2 steps chirurgical treatment

You may qualify if:

  • patients having septic pseudarthrosis of long bone treated at the CRIOAc LYON

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

Study Officials

  • Tristan Ferry

    Hospices Civils de Lyon - Hôpital Croix-Rousse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CRA

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 8, 2018

Study Start

April 1, 2018

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

February 18, 2019

Record last verified: 2019-02

Locations

FR(1)