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Conservative Treatment of Proximal Humeral Fractures

Primary Purpose

Shoulder Fractures

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

conservative treatment

About this trial

This is an interventional treatment trial for Shoulder Fractures

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Cognitive impairment

Sites / Locations

Carlos Torrens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

1-week

3-week

Arm Description

patients undergoing 1-week immobilization period

patients undergoing 3-week immobilization period

Outcomes

Primary Outcome Measures

pain (analogical pain scale)

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

Secondary Outcome Measures

fragment displacement assessed through X-Ray exam

displacement of the fractured fragments within 3 months period assessed through X-Ray exam

functional outcome

functional outcome measured through Constant Score

Full Information

NCT ID

NCT03217344

First Posted

July 4, 2017

Last Updated

March 10, 2019

Sponsor

Hospital del Mar

1. Study Identification

Unique Protocol Identification Number

NCT03217344

Brief Title

Conservative Treatment of Proximal Humeral Fractures

Official Title

Conservative Treatment of Proximal Humeral Fractures - Immobilization for 1 Week Compared to Three Weeks: Prospective Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

October 19, 2015 (Actual)

Primary Completion Date

June 20, 2018 (Actual)

Study Completion Date

June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital del Mar

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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?

Detailed Description

There is still controversy on best treatment of proximal humeral fractures. While some authors propose surgical treatment other advocate for conservative treatment. Traditionally, fractures treated non-operatively undergo a 3-week period of immobilization followed by progressive rehabilitation program. Nevertheless, there is little evidence to support a 3-week immobilization period. The purpose of this study is to bring evidence to support either a 1-week immobilization or 3-week immobilization period in non-operatively treated proximal humeral fractures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

prospective randomized without restrictions

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1-week

Arm Type

Experimental

Arm Description

patients undergoing 1-week immobilization period

Arm Title

3-week

Arm Type

Experimental

Arm Description

patients undergoing 3-week immobilization period

Intervention Type

Procedure

Intervention Name(s)

conservative treatment

Intervention Description

immobilization on sling of the injured arm

Primary Outcome Measure Information:

Title

pain (analogical pain scale)

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

fragment displacement assessed through X-Ray exam

Description

displacement of the fractured fragments within 3 months period assessed through X-Ray exam

Time Frame

3 months

Title

functional outcome

Description

functional outcome measured through Constant Score

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Cognitive impairment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos Torrens, PhD

Organizational Affiliation

Hospital Mar

Official's Role

Principal Investigator

Facility Information:

Facility Name

Carlos Torrens

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35727196

Citation

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.

Results Reference

derived

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Conservative Treatment of Proximal Humeral Fractures

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