Closed Fracture of Shaft of ClavicleNCT03533634
Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate
A study testing Open Reduction Internal Fixation superior plate and Open Reduction Internal Fixation anteroinferior plate in people with Closed Fracture of Shaft of Clavicle, run by UMAE Hospital de Traumatologia y Ortopedia de Puebla.
Trial summary
The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques. the first one was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Closed Fracture of Shaft of Clavicle
- What is being tested?
- Open Reduction Internal Fixation superior plate and Open Reduction Internal Fixation anteroinferior plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 15 Jan 2018
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- traumatic fracture
- ao 15 b1 and 15 b2
- no previous shoulder lesions
- no further 7 days fractures
- closed fracture
Who cannot join
- calcium diseases
- Previous shoulder pain
- other fractures associated
About this study
Official title: Functional Outcome in Midshaft Clavicle Fracture Patients, Treated With Superior Versus Anteroinferior Reconstruction Plate. Randomized Clinical Trial.
The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques. the first one was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the same rehabilitation program and evaluated with functional scores at 30, 60, 90 and 365 days after surgery. biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.
Read the detailed description
The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques.
the first technique was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle.
the patients had the same rehabilitation program and evaluated with Disabilities Arm Shoulder and Hand functional outcome score and Visual Analogue Score for pain at 30, 60, 90 and 365 days after surgery.
biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.
- Conditions
- Closed Fracture of Shaft of Clavicle
- Being tested
- Open Reduction Internal Fixation superior plate, Open Reduction Internal Fixation anteroinferior plate
- Keywords
- midshaft clavicle fracture, functional outcome, anteroinferior plate, superior plate, reconstruction plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Reduction Internal Fixation superior plateProcedure or surgery
3.5mm superior reconstruction plate
Open Reduction Internal Fixation anteroinferior plateProcedure or surgery
3.5mm anteroinferior reconstruction plate
| Study group | Role | What they receive |
|---|---|---|
| superior group | Experimental | this group with midshaft clavicle fracture were treated with superior reconstruction plate Receives: Procedure: Open Reduction Internal Fixation superior plate |
| anteroinferior group | Experimental | this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate Receives: Procedure: Open Reduction Internal Fixation anteroinferior plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of Arm Shoulder and Hand score (DASH)
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Measured: 30 days after surgery
Disabilities of Arm Shoulder and Hand score (DASH)
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Measured: 60 days after surgery
Disabilities of Arm Shoulder and Hand score (DASH)
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Measured: 90 days after surgery
Disabilities of Arm Shoulder and Hand score (DASH)
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Measured: 365 days after surgery
Secondary outcomes (4)
Visual Analogue Scale score (VAS)
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
Measured: 30 days after surgery
Visual Analogue Scale score (VAS)
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
Measured: 60 days after surgery
Visual Analogue Scale score (VAS)
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
Measured: 90 days after surgery
Visual Analogue Scale score (VAS)
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
Measured: 365 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Mar 2015
- Primary completion30 Sep 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed Fracture of Shaft of ClavicleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMAE Hospital de Traumatologia y Ortopedia de Puebla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Antonio Manrique, UMAE Hospital de Traumatologia y Ortopedia de Puebla
- Investigators
- Jose A Manrique, MD, Principal investigator, UMAE Hospital de Traumatologia y Ortopedia de PueblaGustavo Rivera Saldivar, MD, Study chair, UMAE Hospital de Traumatologia y Ortopedia de Puebla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533634
- Sponsor's protocol ID
- UMAE
- Status last verified
- May 2018
- First submitted
- 30 Apr 2018
- Last updated
- 23 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome in Midshaft Clavicle Fracture Patients, Treated With Superior Versus Anteroinferior Reconstruction Plate. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03533634
- Acronym / sponsor ID
- UMAE
- Conditions
- Closed Fracture of Shaft of Clavicle
- Keywords
- midshaft clavicle fracture, functional outcome, anteroinferior plate, superior plate, reconstruction plate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- UMAE Hospital de Traumatologia y Ortopedia de PueblaUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 23 May 2018 (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 purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques. the first one was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the same rehabilitation program and evaluated with functional scores at 30, 60, 90 and 365 days after surgery. biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.
Detailed description
The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques.
the first technique was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle.
the patients had the same rehabilitation program and evaluated with Disabilities Arm Shoulder and Hand functional outcome score and Visual Analogue Score for pain at 30, 60, 90 and 365 days after surgery.
biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| superior group | Experimental | Procedure: Open Reduction Internal Fixation superior platethis group with midshaft clavicle fracture were treated with superior reconstruction plate |
| anteroinferior group | Experimental | Procedure: Open Reduction Internal Fixation anteroinferior platethis group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- traumatic fracture
- ao 15 b1 and 15 b2
- no previous shoulder lesions
- no further 7 days fractures
- closed fracture
Key exclusion criteria (3 listed)
- calcium diseases
- Previous shoulder pain
- other fractures associated
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 |
|---|---|---|
| Open Reduction Internal Fixation superior plate3.5mm superior reconstruction plate | Procedure or surgery | superior group |
| Open Reduction Internal Fixation anteroinferior plate3.5mm anteroinferior reconstruction plate | Procedure or surgery | anteroinferior group |
Primary outcome
Disabilities of Arm Shoulder and Hand score (DASH)
Time frame: 30 days after surgery
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Disabilities of Arm Shoulder and Hand score (DASH)
Time frame: 60 days after surgery
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Disabilities of Arm Shoulder and Hand score (DASH)
Time frame: 90 days after surgery
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Disabilities of Arm Shoulder and Hand score (DASH)
Time frame: 365 days after surgery
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
4 secondary outcomes
Visual Analogue Scale score (VAS)
Time frame: 30 days after surgery
Visual Analogue Scale score (VAS)
Time frame: 60 days after surgery
Visual Analogue Scale score (VAS)
Time frame: 90 days after surgery
Visual Analogue Scale score (VAS)
Time frame: 365 days after surgery
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 23 May 2018.
- Individual participant dataSharing planned: Undecided
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.
Jose A Manrique, MD principal investigator
UMAE Hospital de Traumatologia y Ortopedia de Puebla
Gustavo Rivera Saldivar, MD study chair
UMAE Hospital de Traumatologia y Ortopedia de Puebla
Questions about this trial
What is this clinical trial studying?
A study testing Open Reduction Internal Fixation superior plate and Open Reduction Internal Fixation anteroinferior plate in people with Closed Fracture of Shaft of Clavicle, run by UMAE Hospital de Traumatologia y Ortopedia de Puebla.
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 5 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 23 May 2018. 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?
Disabilities of Arm Shoulder and Hand score (DASH) (time frame: 30 days after surgery). 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 23 May 2018.