Conservative Treatment of Proximal Humeral Fractures

Not Applicable

Completed

• Conditions: Shoulder Fractures
• Interventions: Procedure: conservative treatment

• Registration Number: NCT03217344
• Lead Sponsor: Hospital del Mar

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.

Study Timeline

• Study Start: 2015-10-19
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-14
• Primary Completion: 2018-06-20
• Study Completion: 2018-06-20
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-10
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-week	conservative treatment	patients undergoing 1-week immobilization period
3-week	conservative treatment	patients undergoing 3-week immobilization period

Primary Outcome Measures

Name	Time	Method
pain (analogical pain scale)	1 year	pain assessment through all the follow-up through the analogical pain scale

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Carlos Torrens; 🇪🇸 Barcelona, Spain