## Protocol Section
### Identification Module
**NCT ID:** NCT03786679

**Acronym:** NOSWEPH

**Brief Title:** Non-operative Treatment in Sweden of Proximal Humeral Fractures

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

#### Organization Study ID Info
**ID:** 06000836
#### Organization
**Class:** OTHER_GOV
**Full Name:** Linkoeping University
### Status Module
#### Completion Date
**Date:** 2024-02-25

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-03-08

**Type:** ACTUAL

**Last Update Submit Date:** 2023-03-07

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-02-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-02-25

**Type:** ACTUAL

**Status Verified Date:** 2023-03

#### Study First Post Date
**Date:** 2018-12-26
**Type:** ACTUAL
**Study First Submit Date:** 2018-11-05
**Study First Submit QC Date:** 2018-12-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Lars Adolfsson

#### Responsible Party

**Investigator Affiliation:** Linkoeping University

**Investigator Full Name:** Lars Adolfsson

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Proximal Humeral Fracture

**Keywords:**

- Non-operative treatment, orthosis, healing, rehabilitation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Parallel assignment

##### Masking Info

**Masking:** SINGLE

**Masking Description:** The assessors are not involved in the treatment and the radiological assessment of images will be assessed with anonymyized images.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 400

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Device: Ultrasling ER III orthosis

**Label:** Orthosis group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The patient is instructed to start early rehabilitation about one week after the trauma.

**Intervention Names:**

- Device: Ultrasling ER III orthosis

**Label:** Early rehabilitation group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Early rehabilitation group

- Orthosis group

**Description:** Application of orthosis and start of rehabilitation after four weeks.

**Name:** Ultrasling ER III orthosis

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** recording of fracture union on radiological images

**Measure:** Union of fracture

**Time Frame:** Followed 12 months

#### Secondary Outcomes

**Description:** Shoulder specific patient reported outcome measure, PROM, with a maximum score of 48 points

**Measure:** Oxford shoulder score

**Time Frame:** 12 months

**Description:** Patient reported outcome measure of pain at rest, at night and during activity in scales with 10 steps grading subjective assessment of pain

**Measure:** Numerical pain reporting scale

**Time Frame:** 12 months

**Description:** Patient reported outcome measure of shoulder function in a 11-item PROM

**Measure:** Quick DASH

**Time Frame:** 12 months

**Description:** Patient rated assessment of global improvement in a numeric scale with 7 steps

**Measure:** Global assessment of improvement

**Time Frame:** 12 months

**Description:** The elevation, abduction, internal and external rotation of the injured shoulder

**Measure:** Shoulder range of motion

**Time Frame:** 12 months

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hanna.bjornsson.hallgren@regionostergotland.se

**Name:** Hanna C Björnsson Hallgren, MD, PhD

**Phone:** 0046709473276

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Linköping

**Contacts:**

***Contact 1:***

- **Email:** hanna.bjornsson.hallgren@regionostergotland.se

- **Name:** Hanna C Björnsson Hallgren, MD, PhD

- **Phone:** +46101031000

- **Role:** CONTACT

***Contact 2:***

- **Email:** lars.adolfsonb@regionostergotland.se

- **Name:** lars e adolfsson, MD, PhD

- **Phone:** +46101031000

- **Role:** CONTACT

**Country:** Sweden

**Facility:** Lars Adolfsson

**Status:** RECRUITING

**Zip:** 58185

#### Overall Officials

**Official 1:**

**Affiliation:** Linkoeping University

**Name:** Lars E Adolfsson, Professor

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Linkoeping University

**Name:** Hanna C Björnsson Hallgren, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 35727196

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050723

- Term: Fractures, Bone

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000001134

- Term: Arm Injuries

- ID: D000070599

- Term: Shoulder Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M26370

- Name: Fractures, Bone

- Relevance: LOW

- As Found: Unknown

- ID: M9869

- Name: Humeral Fractures

- Relevance: HIGH

- As Found: Humeral Fractures

- ID: M15592

- Name: Shoulder Fractures

- Relevance: HIGH

- As Found: Proximal Humeral Fracture

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M4444

- Name: Arm Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M602

- Name: Shoulder Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006810

- Term: Humeral Fractures

- ID: D000012784

- Term: Shoulder Fractures

### Misc Info Module

- Version Holder: 2024-05-24
