Conservative Treatment of Proximal Humeral Fractures

Shoulder Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03217344
• Other study ID #: 2016/6588/I
• Status: Completed
• Phase: N/A
• Start date: October 19, 2015
• Est. completion date: June 20, 2018

Study information

• Verified date: March 2019
• Source: Hospital del Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 20, 2018
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Shoulder Fractures

Intervention

Procedure:
• conservative treatment
immobilization on sling of the injured arm

Locations

Country	Name	City	State
Spain	Carlos Torrens	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain (analogical pain scale)	pain assessment through all the follow-up through the analogical pain scale	1 year
Secondary	fragment displacement assessed through X-Ray exam	displacement of the fractured fragments within 3 months period assessed through X-Ray exam	3 months
Secondary	functional outcome	functional outcome measured through Constant Score	1 year