Non-operative Treatment in Sweden of Proximal Humeral Fractures (NOSWEPH)
Primary Purpose
Proximal Humeral Fracture
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Ultrasling ER III orthosis
Sponsored by
About this trial
This is an interventional treatment trial for Proximal Humeral Fracture focused on measuring Non-operative treatment, orthosis, healing, rehabilitation
Eligibility Criteria
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
Sites / Locations
- Lars AdolfssonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Orthosis group
Early rehabilitation group
Arm Description
An orthosis with the broken arm in neutral position fixed for four weeks. After these four weeks the patient is instructed to start rehabilitation.
The patient is instructed to start early rehabilitation about one week after the trauma.
Outcomes
Primary Outcome Measures
Union of fracture
recording of fracture union on radiological images
Secondary Outcome Measures
Oxford shoulder score
Shoulder specific patient reported outcome measure, PROM, with a maximum score of 48 points
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
Quick DASH
Patient reported outcome measure of shoulder function in a 11-item PROM
Global assessment of improvement
Patient rated assessment of global improvement in a numeric scale with 7 steps
Shoulder range of motion
The elevation, abduction, internal and external rotation of the injured shoulder
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03786679
Brief Title
Non-operative Treatment in Sweden of Proximal Humeral Fractures
Acronym
NOSWEPH
Official Title
Non-operative Treatment in Sweden of Proximal Humeral Fratures, a Randomised Multicenter Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
February 25, 2024 (Anticipated)
Study Completion Date
February 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lars Adolfsson
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humeral Fracture
Keywords
Non-operative treatment, orthosis, healing, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
Outcomes Assessor
Masking Description
The assessors are not involved in the treatment and the radiological assessment of images will be assessed with anonymyized images.
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Orthosis group
Arm Type
Active Comparator
Arm Description
An orthosis with the broken arm in neutral position fixed for four weeks. After these four weeks the patient is instructed to start rehabilitation.
Arm Title
Early rehabilitation group
Arm Type
Active Comparator
Arm Description
The patient is instructed to start early rehabilitation about one week after the trauma.
Intervention Type
Device
Intervention Name(s)
Ultrasling ER III orthosis
Intervention Description
Application of orthosis and start of rehabilitation after four weeks.
Primary Outcome Measure Information:
Title
Union of fracture
Description
recording of fracture union on radiological images
Time Frame
Followed 12 months
Secondary Outcome Measure Information:
Title
Oxford shoulder score
Description
Shoulder specific patient reported outcome measure, PROM, with a maximum score of 48 points
Time Frame
12 months
Title
Numerical pain reporting scale
Description
Patient reported outcome measure of pain at rest, at night and during activity in scales with 10 steps grading subjective assessment of pain
Time Frame
12 months
Title
Quick DASH
Description
Patient reported outcome measure of shoulder function in a 11-item PROM
Time Frame
12 months
Title
Global assessment of improvement
Description
Patient rated assessment of global improvement in a numeric scale with 7 steps
Time Frame
12 months
Title
Shoulder range of motion
Description
The elevation, abduction, internal and external rotation of the injured shoulder
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna C Björnsson Hallgren, MD, PhD
Phone
0046709473276
Email
hanna.bjornsson.hallgren@regionostergotland.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars E Adolfsson, Professor
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanna C Björnsson Hallgren, MD, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lars Adolfsson
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna C Björnsson Hallgren, MD, PhD
Phone
+46101031000
Email
hanna.bjornsson.hallgren@regionostergotland.se
First Name & Middle Initial & Last Name & Degree
lars e adolfsson, MD, PhD
Phone
+46101031000
Email
lars.adolfsonb@regionostergotland.se
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35727196
Citation
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(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Results Reference
derived
Learn more about this trial
Non-operative Treatment in Sweden of Proximal Humeral Fractures
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