Prospective Follow-up of the Results of Nail Arthrodesis... | NCT06338566

Studies
Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle

NCT06338566

Sponsor

Direction Centrale du Service de Santé des Armées

Status

Unknown status

Last Update Posted

Mar 29, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Ankle Fractures

Interventions

Follow-up

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2023-A01975-40	Other Identifier	IDRCB

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2024Estimated

Primary Completion Date

Mar 2026Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Mar 21, 2024

First Submission Date that Met QC Criteria

Mar 28, 2024

First Posted Date

Mar 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2024

Last Update Posted Date

Mar 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this prospective, single-center observational study is to describe the functional outcome of the surgical procedure in patient who undergone transplanted centromedullary nailing in the septic setting.

Patients will be asked to complete a questionnaire during follow-up consultations.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Follow-up	Other	Follow-up at D45, 3 months and 6 months, with scoring, radiological monitoring and assessment of wound healing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
bony outcome of transcalcaneal nailing	percentage of patients with aseptic consolidation at 6 months post-op	up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
functional result of the procedure	percentage of patients able to walk again at 6 months post-op	up to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient >18 years
having undergone septic nailing in the operating theatre
with social security coverage

Exclusion Criteria:

Patient with 6-month follow-up not possible (medical wandering, transient patient),
Patient who has benefited from another means of osteosynthesis
Patients whose long-term return to weight-bearing will not be possible for reasons other than ankle arthrodesis surgery.
Persons able to give consent but unable to read or write French
Opposes participation in the study
Patients whose cognitive capacity does not allow them to answer questionnaires

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent ankle surgery and have an ankle arthrodesis.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D064386	Ankle Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D016512	Ankle Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided