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

Primary Purpose

Proximal Humeral Fracture

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Shoulder arm bandage
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Humeral Fracture focused on measuring proximal humeral fractures, conservative treatments

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Bezmialem Vakıf University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Velpau bandage (Group 1)

Shoulder arm sling (Group 2)

Padded shoulder arm sling (Group 3)

Arm Description

Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with velpau bandage.

Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with shoulder arm sling.

Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with padded shoulder arm sling with 30 degree abduction.

Outcomes

Primary Outcome Measures

External rotation degree
degrees of external rotation achieved after conservative follow-up.

Secondary Outcome Measures

Anterior elevation degree
degrees of anterior elevation achieved after conservative follow-up.
Abduction degree
degrees of abduction achieved after conservative follow-up.
Internal rotation degree
degrees of internal rotation achieved after conservative follow-up.
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.
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.
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.
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.

Full Information

First Posted
December 15, 2020
Last Updated
February 23, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04675879
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humeral Fracture
Keywords
proximal humeral fractures, conservative treatments

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Previously randomized patients were divided into 3 groups to be treated with 3 different types of bandages.
Masking
InvestigatorOutcomes Assessor
Masking Description
When the treatments are completed, those who will evaluate the clinical and radiological results will not know the treatment method.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Velpau bandage (Group 1)
Arm Type
Experimental
Arm Description
Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with velpau bandage.
Arm Title
Shoulder arm sling (Group 2)
Arm Type
Experimental
Arm Description
Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with shoulder arm sling.
Arm Title
Padded shoulder arm sling (Group 3)
Arm Type
Experimental
Arm Description
Patients with neer type 2, 3 or 4 proximal humerus fractures under conservative follow-up with padded shoulder arm sling with 30 degree abduction.
Intervention Type
Device
Intervention Name(s)
Shoulder arm bandage
Intervention Description
Three different shoulder-arm bandage types
Primary Outcome Measure Information:
Title
External rotation degree
Description
degrees of external rotation achieved after conservative follow-up.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Anterior elevation degree
Description
degrees of anterior elevation achieved after conservative follow-up.
Time Frame
12 months
Title
Abduction degree
Description
degrees of abduction achieved after conservative follow-up.
Time Frame
12 months
Title
Internal rotation degree
Description
degrees of internal rotation achieved after conservative follow-up.
Time Frame
12 months
Title
DASH Score degree
Description
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
Title
Constant Score degree
Description
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
Title
ASES Score degree
Description
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
Title
VAS Score degree
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Kapıcıoğlu
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Director
Facility Information:
Facility Name
Bezmialem Vakıf University
City
Istanbul
ZIP/Postal Code
34500
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://doi.org/10.1186/s13018-020-01880-7
Description
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
URL
https://doi.org/10.1371/journal.pmed.1002855
Description
Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial . PLOS Medicine
URL
https://doi.org/10.1186/s12891-018-2223-3
Description
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

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

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