An interventional study of Shoulder arm bandage in Proximal Humeral Fracture, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 120 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.
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Exclusion Criteria:
Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with velpau bandage.
Device: Shoulder arm bandage
Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with shoulder arm sling.
Device: Shoulder arm bandage
Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with padded shoulder arm sling with 30 degree abduction.
Device: Shoulder arm bandage
Three different shoulder-arm bandage types
External rotation degree
degrees of external rotation achieved after conservative follow-up.
Time frame: 12 months
Anterior elevation degree
degrees of anterior elevation achieved after conservative follow-up.
Time frame: 12 months
Abduction degree
degrees of abduction achieved after conservative follow-up.
Time frame: 12 months
Internal rotation degree
degrees of internal rotation achieved after conservative follow-up.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Plan to share: Yes — How many patients have been followed up so far?
Supporting information: Csr
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Bezmialem Vakif University