Prospective Evaluation of the Clinical Profile and Treatment Outcomes of Proximal Humerus 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

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-21

Study Completion Date

2023-12-31

Brief Summary

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

With an ageing population, fragility fractures secondary to osteoporosis are on a increasing trend. Proximal humerus fractures are common fractures which account for a significant proportion of these fragility fractures. They significantly affect patients function and independence particularly in the elderly.

Currently, treatment options range from conservative treatment with an arm sling to fixation either with plates or intramedullary devices to arthroplasty ranging from a hemiarthroplasty to the latest reverse shoulder arthroplasty. While is there has been a global trend towards surgical treatment for such fractures, there is significant controversy regarding the best treatment with many studies reporting disappointing functional outcomes including residual shoulder pain, limitation in shoulder motion and decreased quality of life regardless of treatment option selected.

In this day and age where healthcare cost is a big concern both at the individual patient level but at a government level as well, evaluating the cost effectiveness of treatment becomes essential as well. Currently in Singapore, there have been a significant trend of an increased use of surgical treatment of proximal humerus fractures however we have very little data in our local context not only to evaluate the clinical effectiveness but also the cost effectiveness of surgical treatment in comparison to conservative treatment.

The primary aim of the study is

1. To understand the epidemiology and prognostic factors for proximal humerus fractures

* Incidence
* Health service utilization
* clinical and functional outcomes
2. To estimate the relative cost-effectiveness of surgical vs non-surgical treatment pathways for managing patients with proximal humerus fractures.

We hypothesize that surgical fixation of the proximal humerus is both clinically and cost effective

Related Clinical Trials

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

Outcome of Proximal Humerus Fractures :Anatomic Neck Fractures vs Surgical Neck Fractures

NCT03023956

Humeral Fracture, Proximal Internal Fixation; Complications, Mechanical, Bones of Limb

COMPLETED

Study on Outcomes of Proximal Humerus Fractures

NCT07060664

Proximal Humerus Fracture

NOT_YET_RECRUITING NA

Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis

NCT05735561

Proximal Humeral Fracture Dislocation Dislocation Shoulder +2 more

COMPLETED

Influence of Osteoporosis on Clinical Outcomes of Mini-invasive Surgical Treatment of Proximal Humerus Fractures

NCT02750839

Osteoporosis Humerus Fracture

UNKNOWN

Orthopaedic Treatment Proximal Humeral Fractures

NCT03339570

Proximal Humeral Fracture

COMPLETED

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 Humerus Fractures

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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

Inclusion Criteria

1. Age 21 years old and above
2. Radiologically confirmed proximal humerus fracture
3. Within 3 weeks of their injury

Exclusion Criteria

1. Open fracture
2. Mentally incompetent patients
3. Co-morbidities precluding anaesthesia
4. Severe soft tissue compromise
5. Neurovascular compromise
6. Pathological fracture other than osteoporosis
7. Surgery delayed \> 3 weeks
8. Pregnancy

Minimum Eligible Age

21 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No