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

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.

Study Overview

• Status: Completed
• Conditions: Proximal Humeral Fracture
• Intervention / Treatment: Device: Shoulder arm bandage

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34500
    • Bezmialem Vakıf University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Velpau bandage (Group 1); Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with velpau bandage.	Device: Shoulder arm bandage; Three different shoulder-arm bandage types
Experimental: Shoulder arm sling (Group 2); Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with shoulder arm sling.	Device: Shoulder arm bandage; Three different shoulder-arm bandage types
Experimental: Padded shoulder arm sling (Group 3); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
External rotation degree	degrees of external rotation achieved after conservative follow-up.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior elevation degree	degrees of anterior elevation achieved after conservative follow-up.	12 months
Abduction degree	degrees of abduction achieved after conservative follow-up.	12 months
Internal rotation degree	degrees of internal rotation achieved after conservative follow-up.	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.	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.	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.	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.	12 months

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Study Director: Mehmet Kapıcıoğlu, Bezmialem Vakif University

Publications and helpful links

Helpful Links

• 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 Research
• Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial . PLOS Medicine
• 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 prosp

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: proximal humeral fractures; conservative treatments
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: 14052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: How many patients have been followed up so far?
• IPD Sharing Time Frame: 3 months
• IPD Sharing Access Criteria: 6 months and 9 months after the start of the study. June 8 : The number of patients with follow-up reached 45. The 3rd month examinations were performed on half of our patients.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No