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NCT04651543 Clinical Trial

X-Ray Follow-up in Proximal Humeral Fractures Conservatively Treated

Shoulder Fractures Clinical Trial

Official title:
Is a Follow-up Radiological Study at One Week Necessary in Conservatively Treated Fractures of the Proximal Humerus? Randomized Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04651543
Other study ID # 102020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 1, 2022

Study information
Verified date March 2022
Source Hospital del Mar
Contact Carlos Torrens, PhD
Phone 0034932483136
Email 86925@parcdesalutmar.cat
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Randomly assign patients with fractures of the proximal humerus to conservative treatment to a group in which a control radiological study will be carried out after a week of evolution of the fracture and to another group in which this control radiology will not be carried out. In the evolutionary controls, it will be determined whether there are differences between the two groups in the final functional result, in the perception of quality of life, and in the number of complications derived from the fracture.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date December 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - patients> 18 yo and < 85 yo - Fractures of the proximal humerus <3 weeks of evolution. - fractures treated conservatively. - No previous pathology of the affected shoulder. Exclusion Criteria: - dementia - impossibility of carrying out a rehabilitation guideline.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• X-Ray
X-ray obtained at one-week of the fracture

Locations
Country Name City State
Spain Parc de Salut Mar 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 Constant Score (0-100 were 100 is the higher outcomes mean better outcomes) shoulder functional outcome score 2 years
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