Humerus FractureNCT06360848
Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases)
An observational study of Humerus Fracture, run by Ibn Jazzar Hospital.
Trial 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++). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Humerus Fracture
- What is being tested?
- surgery
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 53 cases. of pseudarthrosis of the humeral shaft collected at the surgery department orthopedic and traumatology
Who may be able to join
- - Adult men and women \> 18 years old with pseudarthrosis of the post-fractured humeral diaphysis treated in the orthopedic surgery and traumatology department.
Who cannot join
- - Unusable files.
- Patients lost to follow-up.
- Patients who did not accept therapeutic treatment.
About this study
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.
Read the detailed description
The management of pseudarthrosis of the humerus remains a subject of controversy. Given our results, the investigators think that osteosynthesis by plate associated with bone grafting and/or decortication remains the most suitable for the treatment of aseptic pseudarthroses of the humeral shaft while treatment with Ilizarov is most appropriate in septic pseudarthrosis.
However, the best treatment for pseudarthrosis of the humerus remains that of treating the initial fracture. and better control of pseudoarthrogenic risk factors (tobacco++).
- Conditions
- Humerus Fracture
- Being tested
- surgery
- Keywords
- humerus, pseudarthrosis, screwed plate, external fixator
- Medical subject headings
- Humeral Fractures, Pseudarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryOther
SURGICAL TREATMENT OF PSEUDARTHROSIS OF THE HUMERUS
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of atrophic pseudarthrosis according to technique surgical procedure used (in Number of patients)
Surgical technique Screwed plate:5 Percutaneous pinning:12
Measured: 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
Measured: 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
Measured: 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
Measured: a minimum follow-up of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Jan 2005
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humerus FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Jazzar Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zied Mansi, Ibn Jazzar Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360848
- Sponsor's protocol ID
- IRB00001192
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases)
- ClinicalTrials.gov ID
- NCT06360848
- Acronym / sponsor ID
- IRB00001192
- Conditions
- Humerus Fracture
- Keywords
- humerus, pseudarthrosis, screwed plate, external fixator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ibn Jazzar HospitalUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The management of pseudarthrosis of the humerus remains a subject of controversy. Given our results, the investigators think that osteosynthesis by plate associated with bone grafting and/or decortication remains the most suitable for the treatment of aseptic pseudarthroses of the humeral shaft while treatment with Ilizarov is most appropriate in septic pseudarthrosis.
However, the best treatment for pseudarthrosis of the humerus remains that of treating the initial fracture. and better control of pseudoarthrogenic risk factors (tobacco++).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 53 cases. of pseudarthrosis of the humeral shaft collected at the surgery department orthopedic and traumatology
Key inclusion criteria (1 listed)
- - Adult men and women \> 18 years old with pseudarthrosis of the post-fractured humeral diaphysis treated in the orthopedic surgery and traumatology department.
Key exclusion criteria (3 listed)
- - Unusable files.
- Patients lost to follow-up.
- Patients who did not accept therapeutic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgerySURGICAL TREATMENT OF PSEUDARTHROSIS OF THE HUMERUS | Other | – |
Primary outcome
Distribution of atrophic pseudarthrosis according to technique surgical procedure used (in Number of patients)
Time frame: a minimum follow-up of 10
Surgical technique Screwed plate:5 Percutaneous pinning:12
Distribution of hypertrophic pseudarthrosis according to technique surgical procedure used (in Number of patients)
Time frame: a minimum follow-up of 10 months
Surgical technique Screwed plate:4 Percutaneous pinning:9
Time to consolidation depending on the type of pseudarthrosis (in months)
Time frame: a minimum follow-up of 10 months
Atrophic Pseudarthrosis 4.4 months Pseudarthrosis Aseptic 5.28 months Hypertrophic Pseudarthrosis 5.8 months Septic Pseudarthrosis 4.6 months
Average Constant score postoperatively according to the means of restraint
Time frame: a minimum follow-up of 10 months
Screwed plate(24) :74 External fixator(28) :64 Nailing centromedullary(1) :69
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Humerus Fracture, run by Ibn Jazzar Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of atrophic pseudarthrosis according to technique surgical procedure used (in Number of patients) (time frame: a minimum follow-up of 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.