Conservative Treatment of Proximal Humeral Fractures

Conservative Treatment of Proximal Humeral Fractures - Immobilization for 1 Week Compared to Three Weeks: Prospective Randomized Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03217344

Enrollment

130

Registered

2017-07-14

Start date

2015-10-19

Completion date

2018-06-20

Last updated

2019-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Fractures

Brief summary

Optimal treatment of proximal humeral fractures is yet to be defined. Many of them can be treated non-operatively. The question remains on how long do we have to immobilize non-operatively treated proximal humeral fractures?

Detailed description

There is still controversy on best treatment of proximal humeral fractures. While some authors propose surgical treatment other advocate for conservative treatment. Traditionally, fractures treated non-operatively undergo a 3-week period of immobilization followed by progressive rehabilitation program. Nevertheless, there is little evidence to support a 3-week immobilization period. The purpose of this study is to bring evidence to support either a 1-week immobilization or 3-week immobilization period in non-operatively treated proximal humeral fractures.

Interventions

PROCEDUREconservative treatment

immobilization on sling of the injured arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

prospective randomized without restrictions

Eligibility

Sex/Gender

ALL

Age

60 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Patients ≥ 60 yo and \< 85 yo * Acute fractures less than 1 week evolution * Conservative treatment decided by orthopedic surgeon * Contact between humeral head and humeral shaft. * No gleno-humeral dislocation * No previous surgery

Exclusion criteria

* Cognitive impairment

Design outcomes

Primary

Measure	Time frame	Description
pain (analogical pain scale)	1 year	pain assessment through all the follow-up through the analogical pain scale

Secondary

Measure	Time frame	Description
fragment displacement assessed through X-Ray exam	3 months	displacement of the fractured fragments within 3 months period assessed through X-Ray exam
functional outcome	1 year	functional outcome measured through Constant Score

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026