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Clinical Trials/NCT03217344
NCT03217344
Completed
Not Applicable

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

Hospital del Mar1 site in 1 country130 target enrollmentOctober 19, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Fractures
Sponsor
Hospital del Mar
Enrollment
130
Locations
1
Primary Endpoint
pain (analogical pain scale)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 19, 2015
End Date
June 20, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carlos Torrens

Medical Doctor

Hospital del Mar

Eligibility Criteria

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

Outcomes

Primary Outcomes

pain (analogical pain scale)

Time Frame: 1 year

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

Secondary Outcomes

  • fragment displacement assessed through X-Ray exam(3 months)
  • functional outcome(1 year)

Study Sites (1)

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