NCT05367713

Brief Summary

Osteitis of the cranial flap after craniectomy is an unknown complex osteoarticular infection and there are few data concerning its epidemiology, its risk factors, and its management.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1 month

First QC Date

May 5, 2022

Last Update Submit

May 5, 2022

Conditions

Keywords

Osteitiscranial flap

Outcome Measures

Primary Outcomes (1)

  • rate of cranial flap osteitis after craniectomy

    proportion of patients

    between 2010 and 2021

Secondary Outcomes (1)

  • rate of failure in management of cranial flap osteitis after craniectomy

    between 2010 and 2021

Study Arms (1)

patients having had an osteitis of the cranial flap after craniectomy

Other: patients having had an osteitis of the cranial flap after craniectomy

Interventions

description of management and failure of cranial flap after craniectomy

patients having had an osteitis of the cranial flap after craniectomy

Eligibility Criteria

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

Patients with cranial flap osteitis after craniectomy, treated at CRIOAc Lyon.

You may qualify if:

  • Patients with cranial flap osteitis after craniectomy
  • Patients who did not object to participating in the study
  • Adult patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

RECRUITING

Related Links

MeSH Terms

Conditions

Osteitis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Central Study Contacts

Tristan Ferry, Md,PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 10, 2022

Study Start

April 1, 2022

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations