Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00438633
Status:
COMPLETED
Last Update Posted:
2019-06-21
First Post:
2007-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Early vs Delayed Physical Therapy (Exercises) for Non-Operatively-Treated Proximal Humerus Fractures: A Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.
Detailed Description:
Proximal humerus fractures with limited displacement and fractures that occur in older, less active or infirm patients are treated non-operatively. There is a general impression, supported by some data, that better function is obtained with immediate initiation of shoulder exercises. However, there is some concern that this may contribute to nonunion of the fracture and may be unnecessary. Some researchers have demonstrated better outcomes with immediate rehabilitation with pendulum movements. Others have shown similar functional outcomes when rehabilitation begins approximately a month after injury, or when radiographs show signs of bone healing, and this delay is associated with lower rates of non-union and malunion occurrence.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: