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

• Sponsor: Hospital del Mar (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04651543
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Fractures	Other: X-Ray

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 90 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Is a Follow-up Radiological Study at One Week Necessary in Conservatively Treated Fractures of the Proximal Humerus? Randomized Prospective Study
• Actual Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
no control X-Ray patients with a proximal humeral fracture without one-week X-Ray control	Other: X-Ray; X-ray obtained at one-week of the fracture
one-week X-Ray control patients with a proximal humeral fracture with one-week X-Ray control	Other: X-Ray; X-ray obtained at one-week of the fracture

Outcome Measures

Primary Outcome Measures

1. Constant Score (0-100 were 100 is the higher outcomes mean better outcomes) [2 years]

   shoulder functional outcome score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parc de Salut Mar	Barcelona		Spain	08003

Sponsors and Collaborators

• Hospital del Mar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carlos Torrens, Clinical Professor, Hospital del Mar
• ClinicalTrials.gov Identifier: NCT04651543
• Other Study ID Numbers: 102020
• First Posted: Dec 3, 2020
• Last Update Posted: Apr 8, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Carlos Torrens, Clinical Professor, Hospital del Mar: proximal humeral fractures; conservative treatment; outcomes
• Additional relevant MeSH terms: Fractures, Bone; Humeral Fractures; Shoulder Fractures

Study Results

No Results Posted as of Apr 8, 2022