Non-operative Treatment in Sweden of Proximal Humeral Fractures (NOSWEPH)

Non-operative Treatment in Sweden of Proximal Humeral Fratures, a Randomised Multicenter Trial.

Proximal humeral fractures are common especially in the elderly population. The majority of these fractures are minimally displaced and may be treated non-operatively. There is however a controversy about which fractures that need surgery and randomised trials have not been able to show a clinically important advantage in patient reported outcome measures for those operated. The trend is therefore that also displaced and comminute fractures are treated non-operatively. There is however very little scientific support for how the non-operative treatment should be designed and performed. Therefore this prospective multicenter study is aiming at investigating the benefit of a four week immobilisation orthosis as compared to early range of motion exercises for those patients not assigned for surgery one week after the trauma.

Study Overview

• Status: Recruiting
• Conditions: Proximal Humeral Fracture
• Intervention / Treatment: Device: Ultrasling ER III orthosis

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanna C Björnsson Hallgren, MD, PhD; Phone Number: 0046709473276; Email: hanna.bjornsson.hallgren@regionostergotland.se

Study Locations

• Sweden
  • Linköping, Sweden, 58185
    • Recruiting
    • Lars Adolfsson
    • Contact: Hanna C Björnsson Hallgren, MD, PhD; Phone Number: +46101031000; Email: hanna.bjornsson.hallgren@regionostergotland.se
    • Contact: lars e adolfsson, MD, PhD; Phone Number: +46101031000; Email: lars.adolfsonb@regionostergotland.se

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:

• A proximal humeral fracture verified on radiology no older than 7-10 days.

Exclusion Criteria:

• Surgically treated proximal humeral fracture
• Fracture only involving the greater tuberosity
• Previous surgery in the fractured shoulder
• Ongoing malignancy in the fractured shoulder
• Neurologic disease
• Radiating pain from the neck in the affected arm
• Associated vascular or nerve injuries
• Dementia
• Alcohol abuse
• Unwilling to participate in the trial

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Orthosis group; An orthosis with the broken arm in neutral position fixed for four weeks. After these four weeks the patient is instructed to start rehabilitation.	Device: Ultrasling ER III orthosis; Application of orthosis and start of rehabilitation after four weeks.
Active Comparator: Early rehabilitation group; The patient is instructed to start early rehabilitation about one week after the trauma.	Device: Ultrasling ER III orthosis; Application of orthosis and start of rehabilitation after four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Union of fracture	recording of fracture union on radiological images	Followed 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford shoulder score	Shoulder specific patient reported outcome measure, PROM, with a maximum score of 48 points	12 months
Numerical pain reporting scale	Patient reported outcome measure of pain at rest, at night and during activity in scales with 10 steps grading subjective assessment of pain	12 months
Quick DASH	Patient reported outcome measure of shoulder function in a 11-item PROM	12 months
Global assessment of improvement	Patient rated assessment of global improvement in a numeric scale with 7 steps	12 months
Shoulder range of motion	The elevation, abduction, internal and external rotation of the injured shoulder	12 months

Collaborators and Investigators

• Sponsor: Lars Adolfsson
• Investigators: Principal Investigator: Lars E Adolfsson, Professor, Linkoeping University; Principal Investigator: Hanna C Björnsson Hallgren, MD, PhD, Linkoeping University

Publications and helpful links

General Publications

• Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6:CD000434. doi: 10.1002/14651858.CD000434.pub5. Review.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Anticipated): February 25, 2022
• Study Completion (Anticipated): February 25, 2024

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: December 23, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Non-operative treatment, orthosis, healing, rehabilitation
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Arm Injuries; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: 06000836

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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