Humerus FractureMIPOHNCT04307342
Posterior Minimally Invasive Plate Osteosynthesis (MIPO) for Humerus Diaphyseal Fractures
An observational study of Humerus Fracture, run by Instituto Traumatologico Dr. Teodoro Gebauer Weisser at 1 site in Chile.
Trial summary
The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humerus Fracture
- What is being tested?
- MIPO with Extra-articular Distal Humeral Anatomical Plate
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 1 Jul 2018to Jul 2022
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients consulting in the emergency department of the Instituto Traumatológico for a fracture of the humerus
Who may be able to join
- Closed diaphyseal humerus fracture at the junction of the middle third with distal
Who cannot join
- Open fractures, proximal humerus extension, distal articular compromise, polytrauma, more than 2 weeks of trauma
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Instituto Traumatológico
Santiago, Santiago Metropolitan, 7510664
Julio Contreras, MD, +56979981070, juliocontrerasmd@gmail.com
Julio Contreras, MD
About this study
Official title: Posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate
The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate.
Read the detailed description
The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate.
Clinical
- Pain
- ROM
Functional
- Constant Score
- MEPS
- QuickDASH
Radiological
- Bone union
Complications
- Infection
- Nerve injury
- Conditions
- Humerus Fracture
- Being tested
- MIPO with Extra-articular Distal Humeral Anatomical Plate
- Keywords
- humerus, fracture, osteosynthesis
- Medical subject headings
- Humeral Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIPO with Extra-articular Distal Humeral Anatomical PlateProcedure or surgery
MIPO with Extra-articular Distal Humeral Anatomical Plate
| Study group | Role | What they receive |
|---|---|---|
| Posterior MIPO | Patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate Receives: Procedure: MIPO with Extra-articular Distal Humeral Anatomical Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone union
Radiological Bone union (X-ray or CT)
Measured: 6 months
Secondary outcomes (6)
Pain (Quantity)
Visual Analog Scale
Measured: 1 month, 6 months, 1 year
Range of Motion (Degrees of flexion, extension, pronation and supination)
Physical Exam
Measured: 1 month, 6 months, 1 year
Constant Score
Score
Measured: 1 month, 6 months, 1 year
Mayo Elbow Score
Score
Measured: 1 month, 6 months, 1 year
Quick Disabilities of the Arm, Shoulder and Hand
Score
Measured: 1 month, 6 months, 1 year
Radial nerve injury
Physical exam (electromyography when needed)
Measured: 1 month, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Jul 2018
- Primary completionJul 2021 (estimated)
- Study completionJul 2022 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Instituto Traumatologico Dr. Teodoro Gebauer Weisser
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile
- Responsible party
- Principal investigator, Julio Contreras, Instituto Traumatologico Dr. Teodoro Gebauer Weisser
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307342
- Sponsor's protocol ID
- MIPOH
- Acronym
- MIPOH
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate
- ClinicalTrials.gov ID
- NCT04307342
- Acronym / sponsor ID
- MIPOH / MIPOH
- Conditions
- Humerus Fracture
- Keywords
- humerus, fracture, osteosynthesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Instituto Traumatologico Dr. Teodoro Gebauer WeisserUniversity, hospital or other
- Collaborators
- University of Chile
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 13 Mar 2020 (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.
The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate.
Detailed description
The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate.
Clinical
- Pain
- ROM
Functional
- Constant Score
- MEPS
- QuickDASH
Radiological
- Bone union
Complications
- Infection
- Nerve injury
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posterior MIPO | – | Procedure: MIPO with Extra-articular Distal Humeral Anatomical PlatePatients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting in the emergency department of the Instituto Traumatológico for a fracture of the humerus
Key inclusion criteria (1 listed)
- Closed diaphyseal humerus fracture at the junction of the middle third with distal
Key exclusion criteria (1 listed)
- Open fractures, proximal humerus extension, distal articular compromise, polytrauma, more than 2 weeks of trauma
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 |
|---|---|---|
| MIPO with Extra-articular Distal Humeral Anatomical PlateMIPO with Extra-articular Distal Humeral Anatomical Plate | Procedure or surgery | Posterior MIPO |
Primary outcome
Bone union
Time frame: 6 months
Radiological Bone union (X-ray or CT)
6 secondary outcomes
Pain (Quantity)
Time frame: 1 month, 6 months, 1 year
Range of Motion (Degrees of flexion, extension, pronation and supination)
Time frame: 1 month, 6 months, 1 year
Constant Score
Time frame: 1 month, 6 months, 1 year
Mayo Elbow Score
Time frame: 1 month, 6 months, 1 year
Quick Disabilities of the Arm, Shoulder and Hand
Time frame: 1 month, 6 months, 1 year
Radial nerve injury
Time frame: 1 month, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: Yes
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Enrolling by invitation
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Humerus Fracture, run by Instituto Traumatologico Dr. Teodoro Gebauer Weisser at 1 site in Chile.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone union (time frame: 6 months). 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 13 Mar 2020.