NCT03940638

Brief Summary

The aim of the study was to assess clinical and radiological results with the "induces membrane" technique, described by A. C. Masquelet in 1986, in a series of patients with septic non-union of the tibia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

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

September 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

1 month

First QC Date

May 6, 2019

Last Update Submit

May 7, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of Bone union

    Bone union was defined by 2 continuous cortices on 2 views (radiologic images comprising 2 perpendicular views of the affected segment)

    Day 0

Study Arms (1)

Patients with septic non-union of the tibia

Other: Data collection

Interventions

Data collection

Patients with septic non-union of the tibia

Eligibility Criteria

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

Patients with septic non-union of the tibia managed using the induced membrane technique

You may qualify if:

  • Patients with septic non-union of the tibia
  • managed using the induced membrane technique between novembrer 2007 and novembre 2014 in Reims University hospital
  • Patients who agree to participate to the study
  • Major patient

You may not qualify if:

  • Patient under law protection
  • Minor patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Related Publications (1)

  • Siboni R, Joseph E, Blasco L, Barbe C, Bajolet O, Diallo S, Ohl X. Management of septic non-union of the tibia by the induced membrane technique. What factors could improve results? Orthop Traumatol Surg Res. 2018 Oct;104(6):911-915. doi: 10.1016/j.otsr.2018.04.013. Epub 2018 Jun 7.

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 7, 2019

Study Start

September 1, 2015

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

May 9, 2019

Record last verified: 2019-05

Locations