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

• ClinicalTrials.gov Identifier: NCT04675879
• Recruitment Status: Recruiting
• First Posted: December 19, 2020
• Last Update Posted: June 10, 2021
• Sponsor: Bezmialem Vakif University
• Information provided by (Responsible Party): Murat Sarikas, Bezmialem Vakif University

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.

Condition or disease	Intervention/treatment	Phase
Proximal Humeral Fracture	Device: Shoulder arm bandage	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Previously randomized patients were divided into 3 groups to be treated with 3 different types of bandages.
• 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.
• Primary Purpose: Treatment
• Official Title: Clinical and Radiological Results of Conservative Treatments in Proximal Humerus Fractures.Prospective Randomized Trial
• Actual Study Start Date: December 1, 2020
• Estimated Primary Completion Date: February 1, 2022
• Estimated Study Completion Date: February 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. External rotation degree [ Time Frame: 12 months ]
   degrees of external rotation achieved after conservative follow-up.

Secondary Outcome Measures :

1. Anterior elevation degree [ Time Frame: 12 months ]
   degrees of anterior elevation achieved after conservative follow-up.
2. Abduction degree [ Time Frame: 12 months ]
   degrees of abduction achieved after conservative follow-up.
3. Internal rotation degree [ Time Frame: 12 months ]
   degrees of internal rotation achieved after conservative follow-up.
4. DASH Score degree [ Time Frame: 12 months ]

   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.

5. Constant Score degree [ Time Frame: 12 months ]
   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.
6. ASES Score degree [ Time Frame: 12 months ]
   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.
7. VAS Score degree [ Time Frame: 12 months ]
   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.

Eligibility Criteria

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

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.)

Contacts and Locations

Contacts

Contact: Murat Sarıkaş; 00905414346105; muratsarikas@outlook.com.tr

Locations

Turkey

Bezmialem Vakıf University; Recruiting

Istanbul, Turkey, 34500

Contact: Murat Sarıkaş 00905414346105 muratsarikas@outlook.com.tr

Sponsors and Collaborators

Bezmialem Vakif University

Investigators

• Study Director: Mehmet Kapıcıoğlu; Bezmialem Vakif University

More Information

Additional Information:

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 

• Responsible Party: Murat Sarikas, Recident of orthopaedic surgery, Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT04675879
• Other Study ID Numbers: 14052
• First Posted: December 19, 2020
• Last Update Posted: June 10, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: How many patients have been followed up so far?
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: 3 months
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Murat Sarikas, Bezmialem Vakif University:

proximal humeral fractures; conservative treatments

Additional relevant MeSH terms:

Fractures, Bone; Humeral Fractures; Shoulder Fractures; Wounds and Injuries; Arm Injuries; Shoulder Injuries