Non-operative Treatment in Sweden of Proximal Humeral Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2024-02-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Proximal Humeral Fractures

NCT01246167

Humeral Fractures, Proximal

COMPLETED NA

Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus

NCT00835562

Proximal Humeral Fractures

UNKNOWN PHASE3

Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture

NCT00326794

Shoulder Fracture

TERMINATED PHASE3

Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years

NCT06416618

Proximal Humeral Fracture Shoulder Fractures

RECRUITING NA

Conservative Treatment of Proximal Humeral Fractures

NCT03217344

Shoulder Fractures

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Proximal Humeral Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Ultrasling ER III orthosis

Intervention Type DEVICE

Application of orthosis and start of rehabilitation after four weeks.

Early rehabilitation group

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

Group Type ACTIVE_COMPARATOR

Ultrasling ER III orthosis

Intervention Type DEVICE

Application of orthosis and start of rehabilitation after four weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasling ER III orthosis

Application of orthosis and start of rehabilitation after four weeks.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No