Proximal Humeral FractureNOSWEPHNCT03786679
Non-operative Treatment in Sweden of Proximal Humeral Fractures
A study testing Ultrasling ER III orthosis in people with Proximal Humeral Fracture, run by Lars Adolfsson at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- Ultrasling ER III orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 25 Feb 2019to 25 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A proximal humeral fracture verified on radiology no older than 7-10 days.
Who cannot join
- 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
Show all 10Show fewer
- Associated vascular or nerve injuries
- Dementia
- Alcohol abuse
- Unwilling to participate in the trial
Trial locations and contacts
1 site in 1 country.
Hanna C Björnsson Hallgren, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Lars Adolfsson
Linköping, 58185
Hanna C Björnsson Hallgren, MD, PhD, +46101031000, hanna.bjornsson.hallgren@regionostergotland.se
lars e adolfsson, MD, PhD, +46101031000, lars.adolfsonb@regionostergotland.se
About this study
Official title: 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.
- Conditions
- Proximal Humeral Fracture
- Being tested
- Ultrasling ER III orthosis
- Keywords
- Non-operative treatment, orthosis, healing, rehabilitation
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasling ER III orthosisDevice
Application of orthosis and start of rehabilitation after four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Orthosis group | Active comparator | An orthosis with the broken arm in neutral position fixed for four weeks. After these four weeks the patient is instructed to start rehabilitation. Receives: Device: Ultrasling ER III orthosis |
| Early rehabilitation group | Active comparator | The patient is instructed to start early rehabilitation about one week after the trauma. Receives: Device: Ultrasling ER III orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Union of fracture
recording of fracture union on radiological images
Measured: Followed 12 months
Secondary outcomes (5)
Oxford shoulder score
Shoulder specific patient reported outcome measure, PROM, with a maximum score of 48 points
Measured: 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
Measured: 12 months
Quick DASH
Patient reported outcome measure of shoulder function in a 11-item PROM
Measured: 12 months
Global assessment of improvement
Patient rated assessment of global improvement in a numeric scale with 7 steps
Measured: 12 months
Shoulder range of motion
The elevation, abduction, internal and external rotation of the injured shoulder
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start25 Feb 2019
- Primary completion25 Feb 2024 (estimated)
- Study completion25 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lars Adolfsson
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Lars Adolfsson, Linkoeping University
- Investigators
- Lars E Adolfsson, Professor, Principal investigator, Linkoeping UniversityHanna C Björnsson Hallgren, MD, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786679
- Sponsor's protocol ID
- 06000836
- Acronym
- NOSWEPH
- Status last verified
- Mar 2023
- First submitted
- 5 Nov 2018
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PubMed 35727196
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-operative Treatment in Sweden of Proximal Humeral Fratures, a Randomised Multicenter Trial.
- ClinicalTrials.gov ID
- NCT03786679
- Acronym / sponsor ID
- NOSWEPH / 06000836
- Conditions
- Proximal Humeral Fracture
- Keywords
- Non-operative treatment, orthosis, healing, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Lars AdolfssonOther government
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 25 Feb 2024 (estimated)
- Study completion
- 25 Feb 2024 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Orthosis group | Active comparator | Device: Ultrasling ER III orthosisAn orthosis with the broken arm in neutral position fixed for four weeks. After these four weeks the patient is instructed to start rehabilitation. |
| Early rehabilitation group | Active comparator | Device: Ultrasling ER III orthosisThe patient is instructed to start early rehabilitation about one week after the trauma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A proximal humeral fracture verified on radiology no older than 7-10 days.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasling ER III orthosisApplication of orthosis and start of rehabilitation after four weeks. | Device | Early rehabilitation group, Orthosis group |
Primary outcome
Union of fracture
Time frame: Followed 12 months
recording of fracture union on radiological images
5 secondary outcomes
Oxford shoulder score
Time frame: 12 months
Numerical pain reporting scale
Time frame: 12 months
Quick DASH
Time frame: 12 months
Global assessment of improvement
Time frame: 12 months
Shoulder range of motion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 35727196Handoll 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna C Björnsson Hallgren, MD, PhD contact
Lars E Adolfsson, Professor principal investigator
Linkoeping University
Hanna C Björnsson Hallgren, MD, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasling ER III orthosis in people with Proximal Humeral Fracture, run by Lars Adolfsson at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna C Björnsson Hallgren, MD, PhD (0046709473276, hanna.bjornsson.hallgren@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Union of fracture (time frame: Followed 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03786679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.