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OpenTrials
Completed

NCT Number: NCT03217344

Conservative Treatment of Proximal Humeral Fractures

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?

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Key information

Conditions

Shoulder Fractures Fractures, Bone Shoulder Injuries Wounds and Injuries

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carlos Torrens

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conservative treatment

Procedure

immobilization on sling of the injured arm

Primary outcomes

  1. pain (analogical pain scale)

    Time frame: 1 year

    pain assessment through all the follow-up through the analogical pain scale

Secondary outcomes

  1. fragment displacement assessed through X-Ray exam

    Time frame: 3 months

    displacement of the fractured fragments within 3 months period assessed through X-Ray exam

  2. functional outcome

    Time frame: 1 year

    functional outcome measured through Constant Score

Sponsors and collaborators

Lead sponsor

Hospital del Mar

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2017
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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