Clinical trial NCT04675879: Clinical and Radiological Results of Conservative Treatments in Proximal Humerus Fractures.
Official title: Clinical and Radiological Results of Conservative Treatments in Proximal Humerus Fractures.Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Humeral Fracture
Keywords: proximal humeral fractures
conservative treatments
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Previously randomized patients were divided into 3 groups to be treated with 3 different types of bandages.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: External rotation degree
timeFrame: 12 months
Secondary outcomes:
measure: Anterior elevation degree
timeFrame: 12 months
measure: Abduction degree
timeFrame: 12 months
measure: Internal rotation degree
timeFrame: 12 months
measure: DASH Score degree
timeFrame: 12 months
measure: Constant Score degree
timeFrame: 12 months
measure: ASES Score degree
timeFrame: 12 months
measure: VAS Score degree
timeFrame: 12 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
affiliation: Bezmialem Vakif University
name: Mehmet Kapıcıoğlu
role: STUDY_DIRECTOR
References: