Proximal Humeral FractureNCT04675879
Clinical and Radiological Results of Conservative Treatments in Proximal Humerus Fractures.
A study testing Shoulder arm bandage in people with Proximal Humeral Fracture, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
In the investigators' prospective randomized study, the investigator will investigate the effect of different bandage types on functional and radiological results of proximal humerus fractures over 18 years of age, for whom conservative treatment is decided. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- Shoulder arm bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 23 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neer type 2, 3 and 4 proximal humerus fractures suitable for conservative follow-up
- Patients older than 18 years
Who cannot join
- Previous surgery in the ipsilateral shoulder area
- Fractured dislocation
- Patients with open phys line
- Patients with neurological problems affecting the upper extremity (MS, stroke, etc.)
- Patients with fracture-induced neurovascular problems
- Open fractures
- Patients who require surgery for any reason while follw-up (malunion, nonunion, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiological Results of Conservative Treatments in Proximal Humerus Fractures.Prospective Randomized Trial
In the investigators' prospective randomized study, the investigator will investigate the effect of different bandage types on functional and radiological results of proximal humerus fractures over 18 years of age, for whom conservative treatment is decided.
In recent studies, it has been shown that surgical treatment in proximal humerus fractures has a high complication rate and is also not superior to conservative treatments in terms of functional results. Therefore, the importance of conservative treatment is increasing day by day in this group of fractures, especially in elderly patients with high risk for surgery.
In these studies in the literature, the method in conservative treatment is not clearly specified, and the investigator will apply 3 different bandages to adjust the rotation of the shoulder in 3 different ways during the investigators' conservative treatment. The investigator will compare functional and radiological results between these groups.
Read the detailed description
Proximal humerus fractures, who are admitted to the investigators' emergency department and are decided to follow conservative follow-up criteria, will be given one of 3 different bandages (velpau bandage, classical shoulder arm sling, 30 degree padded shoulder arm sling) according to the previous randomization.
Routinely, at the 2nd week, 6th week, 12th week, 6th month and 12th month outpatient clinic controls, the patients will be seen and their X-ray and clinical satisfaction status will be checked. X-rays will be taken as classical ap / lateral and true ap.
At the end of the second week, which is absolute immobilization, elbow and wrist movements will begin. Afterwards, in the 6th week, according to the state of union with deltoid strengthening, passive and active shoulder joint range of motion exercises will be started.
At the end of the 12th month, the follow-up will be terminated, and in this control, the existing joint movements will be recorded by measuring the degrees of anterior elevation, abduction, external rotation in neutral, external rotation at 90 degrees and internal rotation. In addition, in this control, the values will be noted by taking the Constant, ASES, DASH and VAS Scores.
After all these values are noted for all 3 groups, statistical analysis between groups will be made for each variable and the result will be given.
In addition, if complications(non-union,mal-union,stiffness etc.) occur during conservative follow-up in the investigators' patients, they will be recorded and whether there is a statistically significant difference in complications between the groups will be investigated.
The investigators' aim in this study is to understand whether any of these 3 different bandage types, which are routinely used as an immobilization method in proximal humerus fractures, are superior to the other.
A study comparing immobilization methods could not be found in the literature. These bandage types, which have not been compared with their effectiveness, are used effectively all over the world. With this study, the investigator set this on a scientific basis and set the correct direction of the investigators' treatments as the investigators' main goal.
- Conditions
- Proximal Humeral Fracture
- Being tested
- Shoulder arm bandage
- Keywords
- proximal humeral fractures, conservative treatments
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder arm bandageDevice
Three different shoulder-arm bandage types
| Study group | Role | What they receive |
|---|---|---|
| Velpau bandage (Group 1) | Experimental | Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with velpau bandage. Receives: Device: Shoulder arm bandage |
| Shoulder arm sling (Group 2) | Experimental | Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with shoulder arm sling. Receives: Device: Shoulder arm bandage |
| Padded shoulder arm sling (Group 3) | Experimental | Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with padded shoulder arm sling with 30 degree abduction. Receives: Device: Shoulder arm bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
External rotation degree
degrees of external rotation achieved after conservative follow-up.
Measured: 12 months
Secondary outcomes (7)
Anterior elevation degree
degrees of anterior elevation achieved after conservative follow-up.
Measured: 12 months
Abduction degree
degrees of abduction achieved after conservative follow-up.
Measured: 12 months
Internal rotation degree
degrees of internal rotation achieved after conservative follow-up.
Measured: 12 months
DASH Score degree
DASH score obtained at the end of follow-up of patients who completed 12 months of conservative follow-up.
Minimum and maximum values are respectively 0 and 100. Higher scores mean a worse outcome.
Measured: 12 months
Constant Score degree
Constant score obtained at the end of follow-up of patients who completed 12 months of conservative follow-up Minimum and maximum values are respectively 8 and 100. Higher scores mean a better outcome.
Measured: 12 months
ASES Score degree
ASES score obtained at the end of follow-up of patients who completed 12 months of conservative follow-up Minimum and maximum values are respectively 0 and 100. Higher scores mean a better outcome.
Measured: 12 months
VAS Score degree
VAS score obtained at the end of follow-up of patients who completed 12 months of conservative follow-up Minimum and maximum values are respectively 0 and 10. Higher scores mean a worse outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Dec 2020
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humeral FractureStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Previously randomized patients were divided into 3 groups to be treated with 3 different types of bandages.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Sarikas, Bezmialem Vakif University
- Investigators
- Mehmet Kapıcıoğlu, Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675879
- Sponsor's protocol ID
- 14052
- Status last verified
- Feb 2023
- First submitted
- 15 Dec 2020
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: How many patients have been followed up so far?
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Results of Conservative Treatments in Proximal Humerus Fractures.Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04675879
- Acronym / sponsor ID
- 14052
- Conditions
- Proximal Humeral Fracture
- Keywords
- proximal humeral fractures, conservative treatments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 19 Dec 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.
In the investigators' prospective randomized study, the investigator will investigate the effect of different bandage types on functional and radiological results of proximal humerus fractures over 18 years of age, for whom conservative treatment is decided.
In recent studies, it has been shown that surgical treatment in proximal humerus fractures has a high complication rate and is also not superior to conservative treatments in terms of functional results. Therefore, the importance of conservative treatment is increasing day by day in this group of fractures, especially in elderly patients with high risk for surgery.
In these studies in the literature, the method in conservative treatment is not clearly specified, and the investigator will apply 3 different bandages to adjust the rotation of the shoulder in 3 different ways during the investigators' conservative treatment. The investigator will compare functional and radiological results between these groups.
Detailed description
Proximal humerus fractures, who are admitted to the investigators' emergency department and are decided to follow conservative follow-up criteria, will be given one of 3 different bandages (velpau bandage, classical shoulder arm sling, 30 degree padded shoulder arm sling) according to the previous randomization.
Routinely, at the 2nd week, 6th week, 12th week, 6th month and 12th month outpatient clinic controls, the patients will be seen and their X-ray and clinical satisfaction status will be checked. X-rays will be taken as classical ap / lateral and true ap.
At the end of the second week, which is absolute immobilization, elbow and wrist movements will begin. Afterwards, in the 6th week, according to the state of union with deltoid strengthening, passive and active shoulder joint range of motion exercises will be started.
At the end of the 12th month, the follow-up will be terminated, and in this control, the existing joint movements will be recorded by measuring the degrees of anterior elevation, abduction, external rotation in neutral, external rotation at 90 degrees and internal rotation. In addition, in this control, the values will be noted by taking the Constant, ASES, DASH and VAS Scores.
After all these values are noted for all 3 groups, statistical analysis between groups will be made for each variable and the result will be given.
In addition, if complications(non-union,mal-union,stiffness etc.) occur during conservative follow-up in the investigators' patients, they will be recorded and whether there is a statistically significant difference in complications between the groups will be investigated.
The investigators' aim in this study is to understand whether any of these 3 different bandage types, which are routinely used as an immobilization method in proximal humerus fractures, are superior to the other.
A study comparing immobilization methods could not be found in the literature. These bandage types, which have not been compared with their effectiveness, are used effectively all over the world. With this study, the investigator set this on a scientific basis and set the correct direction of the investigators' treatments as the investigators' main goal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Previously randomized patients were divided into 3 groups to be treated with 3 different types of bandages.
| Arm | Type | Receives |
|---|---|---|
| Velpau bandage (Group 1) | Experimental | Device: Shoulder arm bandagePatients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with velpau bandage. |
| Shoulder arm sling (Group 2) | Experimental | Device: Shoulder arm bandagePatients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with shoulder arm sling. |
| Padded shoulder arm sling (Group 3) | Experimental | Device: Shoulder arm bandagePatients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with padded shoulder arm sling with 30 degree abduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Neer type 2, 3 and 4 proximal humerus fractures suitable for conservative follow-up
- Patients older than 18 years
Key exclusion criteria (7 listed)
- Previous surgery in the ipsilateral shoulder area
- Fractured dislocation
- Patients with open phys line
- Patients with neurological problems affecting the upper extremity (MS, stroke, etc.)
- Patients with fracture-induced neurovascular problems
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 |
|---|---|---|
| Shoulder arm bandageThree different shoulder-arm bandage types | Device | Padded shoulder arm sling (Group 3), Shoulder arm sling (Group 2), Velpau bandage (Group 1) |
Primary outcome
External rotation degree
Time frame: 12 months
degrees of external rotation achieved after conservative follow-up.
7 secondary outcomes
Anterior elevation degree
Time frame: 12 months
Abduction degree
Time frame: 12 months
Internal rotation degree
Time frame: 12 months
DASH Score degree
Time frame: 12 months
Constant Score degree
Time frame: 12 months
ASES Score degree
Time frame: 12 months
VAS Score degree
Time frame: 12 months
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 24 Feb 2023.
- Manuel Soler-Peiro , Lorena García-Martínez , Luis Aguilella and Marcelino Perez-Bermejo . Conservative treatment of 3-part and 4-part proximal humeral fractures: a systematic review . Soler-Peiro et al. Journal of Orthopaedic Surgery and ResearchLink provided by the sponsor.
- Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial . PLOS MedicineLink provided by the sponsor.
- Lisa Howard , Randa Berdusco , Franco Momoli , J. Pollock , Allan Liew , Steve Papp , Karl-Andre Lalonde , Wade Gofton , Sara Ruggiero and Peter Lapner . Open reduction internal fixation vs non- operative management in proximal humerus fractures: a prospLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. How many patients have been followed up so far?
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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.
Mehmet Kapıcıoğlu study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder arm bandage in people with Proximal Humeral Fracture, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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 24 Feb 2023. 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 Turkey (Türkiye). 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?
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?
External rotation degree (time frame: 12 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 24 Feb 2023.