X-Ray Follow-up in Proximal Humeral Fractures Conservativ... | NCT04651543

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

NCT04651543

Sponsor

Hospital del Mar

Status

Unknown status

Last Update Posted

Apr 8, 2022Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Shoulder Fractures

Interventions

X-Ray

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Nov 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Nov 26, 2020

First Submission Date that Met QC Criteria

Dec 2, 2020

First Posted Date

Dec 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2022

Last Update Posted Date

Apr 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
X-Ray	Other	X-ray obtained at one-week of the fracture	no control X-Ray one-week X-Ray control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Constant Score (0-100 were 100 is the higher outcomes mean better outcomes)	shoulder functional outcome score	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

patients with proximal humeral fractures

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carlos Torrens, PhD	Contact	0034932483136	3136	86925@parcdesalutmar.cat

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parc de Salut Mar	Recruiting	Barcelona		08003	Spain

Condition Browse Module

MeSH Terms

ID	Term
D012784	Shoulder Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D000070599	Shoulder Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014965	X-Rays

Ancestor Terms

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided