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

NCT04651543 | Unknown DMC

• 1 other identifier: 102020
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Fractures

Keywords

proximal humeral fractures; conservative treatment; outcomes

Outcome Measures

Primary Outcomes (1)

• Constant Score (0-100 were 100 is the higher outcomes mean better outcomes)

  shoulder functional outcome score

  2 years

Study Arms (2)

no control X-Ray

patients with a proximal humeral fracture without one-week X-Ray control

Other: X-Ray

one-week X-Ray control

patients with a proximal humeral fracture with one-week X-Ray control

Other: X-Ray

Interventions

X-Ray OTHER

X-ray obtained at one-week of the fracture

no control X-Ray; one-week X-Ray control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with proximal humeral fractures

You may qualify if:

• 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.

You may not qualify if:

• dementia
• impossibility of carrying out a rehabilitation guideline.

Sponsors & Collaborators

• Hospital del Mar: lead

Study Sites (1)

Parc de Salut Mar

Barcelona, 08003, Spain

RECRUITING

MeSH Terms

Conditions

Shoulder Fractures

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Central Study Contacts

Carlos Torrens, PhD

CONTACT

0034932483136; 86925@parcdesalutmar.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: December 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-03

Locations

ES (1)