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

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ClinicalTrials.gov Identifier: NCT03786679
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Lars Adolfsson, Linkoeping University

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.

Condition or disease Intervention/treatment Phase
Proximal Humeral Fracture Device: Ultrasling ER III orthosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Single (Outcomes Assessor)
Masking Description: The assessors are not involved in the treatment and the radiological assessment of images will be assessed with anonymyized images.
Primary Purpose: Treatment
Official Title: Non-operative Treatment in Sweden of Proximal Humeral Fratures, a Randomised Multicenter Trial.
Estimated Study Start Date : February 25, 2019
Estimated Primary Completion Date : February 25, 2022
Estimated Study Completion Date : February 25, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Union of fracture [ Time Frame: Followed 12 months ]
    recording of fracture union on radiological images


Secondary Outcome Measures :
  1. Oxford shoulder score [ Time Frame: 12 months ]
    Shoulder specific patient reported outcome measure, PROM, with a maximum score of 48 points

  2. Numerical pain reporting scale [ Time Frame: 12 months ]
    Patient reported outcome measure of pain at rest, at night and during activity in scales with 10 steps grading subjective assessment of pain

  3. Quick DASH [ Time Frame: 12 months ]
    Patient reported outcome measure of shoulder function in a 11-item PROM

  4. Global assessment of improvement [ Time Frame: 12 months ]
    Patient rated assessment of global improvement in a numeric scale with 7 steps

  5. Shoulder range of motion [ Time Frame: 12 months ]
    The elevation, abduction, internal and external rotation of the injured shoulder



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786679


Contacts
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Contact: Hanna C Björnsson Hallgren, MD, PhD 0046709473276 hanna.bjornsson.hallgren@regionostergotland.se

Sponsors and Collaborators
Lars Adolfsson
Investigators
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Principal Investigator: Lars E Adolfsson, Professor Linkoeping University
Principal Investigator: Hanna C Björnsson Hallgren, MD, PhD Linkoeping University

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Responsible Party: Lars Adolfsson, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT03786679     History of Changes
Other Study ID Numbers: 06000836
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Lars Adolfsson, Linkoeping University:
Non-operative treatment, orthosis, healing, rehabilitation

Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries
Shoulder Injuries