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Clinical and Radiological Results of Conservative Treatments in Proximal Humerus Fractures.

Clinical and Radiological Results of Conservative Treatments in Proximal Humerus Fractures.Prospective Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04675879
Enrollment
120
Registered
2020-12-19
Start date
2020-12-01
Completion date
2023-02-23
Last updated
2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Humeral Fracture

Keywords

proximal humeral fractures, conservative treatments

Brief 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. 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.

Interventions

DEVICEShoulder arm bandage

Three different shoulder-arm bandage types

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

When the treatments are completed, those who will evaluate the clinical and radiological results will not know the treatment method.

Intervention model description

Previously randomized patients were divided into 3 groups to be treated with 3 different types of bandages.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Neer type 2, 3 and 4 proximal humerus fractures suitable for conservative follow-up * Patients older than 18 years

Exclusion criteria

* 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.)

Design outcomes

Primary

MeasureTime frameDescription
External rotation degree12 monthsdegrees of external rotation achieved after conservative follow-up.

Secondary

MeasureTime frameDescription
Abduction degree12 monthsdegrees of abduction achieved after conservative follow-up.
Internal rotation degree12 monthsdegrees of internal rotation achieved after conservative follow-up.
DASH Score degree12 monthsDASH 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.
Anterior elevation degree12 monthsdegrees of anterior elevation achieved after conservative follow-up.
ASES Score degree12 monthsASES 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.
VAS Score degree12 monthsVAS 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.
Constant Score degree12 monthsConstant 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026