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

NCT04675879 | Completed

• 1 other identifier: 14052
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Humeral Fracture

Keywords

proximal humeral fractures; conservative treatments

Outcome Measures

Primary Outcomes (1)

• External rotation degree

  degrees of external rotation achieved after conservative follow-up.

  12 months

Secondary Outcomes (7)

• Anterior elevation degree

  12 months

• Abduction degree

  12 months

• Internal rotation degree

  12 months

• DASH Score degree

  12 months

• Constant Score degree

  12 months

Study Arms (3)

Velpau bandage (Group 1)

EXPERIMENTAL

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

Device: Shoulder arm bandage

Shoulder arm sling (Group 2)

EXPERIMENTAL

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

Device: Shoulder arm bandage

Padded shoulder arm sling (Group 3)

EXPERIMENTAL

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

Interventions

Shoulder arm bandage DEVICE

Three different shoulder-arm bandage types

Padded shoulder arm sling (Group 3); Shoulder arm sling (Group 2); Velpau bandage (Group 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34500, Turkey (Türkiye)

Location

Related 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

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Officials

• Mehmet Kapıcıoğlu

  Bezmialem Vakif University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: When the treatments are completed, those who will evaluate the clinical and radiological results will not know the treatment method.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Recident of orthopaedic surgery

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

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 19, 2020
• Study Start: December 1, 2020
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

TU (1)