NCT03217344

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

July 4, 2017

Last Update Submit

March 10, 2019

Conditions

Shoulder Fractures

Outcome Measures

Primary Outcomes (1)

  • pain (analogical pain scale)

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

    1 year

Secondary Outcomes (2)

  • fragment displacement assessed through X-Ray exam

    3 months

  • functional outcome

    1 year

Study Arms (2)

1-week

EXPERIMENTAL

patients undergoing 1-week immobilization period

Procedure: conservative treatment

3-week

EXPERIMENTAL

patients undergoing 3-week immobilization period

Procedure: conservative treatment

Interventions

conservative treatmentPROCEDURE

immobilization on sling of the injured arm

1-week3-week

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carlos Torrens

Barcelona, 08003, Spain

Location

Related Publications (1)

  • Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

    PMID: 35727196DERIVED

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Carlos Torrens, PhD

    Hospital Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective randomized without restrictions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 14, 2017

Study Start

October 19, 2015

Primary Completion

June 20, 2018

Study Completion

June 20, 2018

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

ES(1)