NCT06360848

Brief Summary

Pseudarthrosis of the humerus is a serious complication of humerus fractures, of particular interest to subjects young working people with pseudoarthrogenic risk factors (tobacco++). It represents a real problem therapeutic given the long period of treatment, its disabling socio-professional repercussions and the cost which resulting. The aim of our work is to evaluate the anatomical and functional results of different surgical techniques. used.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

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

January 1, 2005

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

16 years

First QC Date

March 26, 2024

Last Update Submit

April 8, 2024

Conditions

Keywords

humeruspseudarthrosisscrewed plateexternal fixator

Outcome Measures

Primary Outcomes (4)

  • Distribution of atrophic pseudarthrosis according to technique surgical procedure used (in Number of patients)

    Surgical technique Screwed plate:5 Percutaneous pinning:12

    a minimum follow-up of 10

  • Distribution of hypertrophic pseudarthrosis according to technique surgical procedure used (in Number of patients)

    Surgical technique Screwed plate:4 Percutaneous pinning:9

    a minimum follow-up of 10 months

  • Time to consolidation depending on the type of pseudarthrosis (in months)

    Atrophic Pseudarthrosis 4.4 months Pseudarthrosis Aseptic 5.28 months Hypertrophic Pseudarthrosis 5.8 months Septic Pseudarthrosis 4.6 months

    a minimum follow-up of 10 months

  • Average Constant score postoperatively according to the means of restraint

    Screwed plate(24) :74 External fixator(28) :64 Nailing centromedullary(1) :69

    a minimum follow-up of 10 months

Interventions

surgeryOTHER

SURGICAL TREATMENT OF PSEUDARTHROSIS OF THE HUMERUS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

53 cases. of pseudarthrosis of the humeral shaft collected at the surgery department orthopedic and traumatology

You may qualify if:

  • \- Adult men and women \> 18 years old with pseudarthrosis of the post-fractured humeral diaphysis treated in the orthopedic surgery and traumatology department.

You may not qualify if:

  • \- Unusable files.
  • Patients lost to follow-up.
  • Patients who did not accept therapeutic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Humeral FracturesPseudarthrosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, BoneFractures, Ununited

Study Design

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

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 11, 2024

Study Start

January 1, 2005

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share