Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04786639
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2021-03-03
Brief Title:
Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
Comparison of Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures
Status:
COMPLETED
Status Verified Date:
2023-07
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 management of proximal humerus fractures PHFs remains a significant challenge in orthopaedics The acute treatment options for PHFs are numerous and are typically guided by the fracture pattern and functional demands of the patients The most commonly used methods include non-operative management with a sling or surgical fixation Although non-surgical treatment is a reasonable treatment option for the majority of humerus fractures there is an increasing interest in surgical intervention There are no evidence-based treatment recommendations thus permitting large local variation in treatment preferences
There are a number of studies in the literature about how outcome measures of the patients after PHFs management change but these results generally compare functional results before and after treatment Misra et al stated that conservatively managed patients with PHFs have more pain and a poorer range of motion than those managed by either fixation or arthroplasty while cochrane review stated that surgery is not superior to nonsurgical treatment in most proximal humerus fractures Jayakumar et al determined that kinesiophobia is one of the strongest predictors of functional limitation and recovery from a PHF is enhanced by overcoming fears of movement or reinjury within a week after injury
There is no clear knowledge regarding how the surgical or conservative management used in the management of PHF affects the early results of assessment parameters The aim of this study was to compare early results of surgical fixation versus non-operative management outcomes in patients with proximal humerus fractures
There are a number of studies in the literature about how outcome measures of the patients after PHFs management change but these results generally compare functional results before and after treatment Misra et al stated that conservatively managed patients with PHFs have more pain and a poorer range of motion than those managed by either fixation or arthroplasty while cochrane review stated that surgery is not superior to nonsurgical treatment in most proximal humerus fractures Jayakumar et al determined that kinesiophobia is one of the strongest predictors of functional limitation and recovery from a PHF is enhanced by overcoming fears of movement or reinjury within a week after injury
There is no clear knowledge regarding how the surgical or conservative management used in the management of PHF affects the early results of assessment parameters The aim of this study was to compare early results of surgical fixation versus non-operative management outcomes in patients with proximal humerus fractures
Detailed Description:
Voluntary patients who have been diagnosed with proximal humerus fracture and managed by surgical or conservative will be included in the study
Patients with stabilization after proximal humerus fracture with surgical fixation will be considered as the Surgery group and patients treated with non-surgical treatment with sling immobilization will be considered as the Conservative group Signed voluntary consent will be obtained from participants Patients having surgical fixation or nonoperative management will be assessed for kinesiophobia pain range of motion functional status and quality of life
Patients with stabilization after proximal humerus fracture with surgical fixation will be considered as the Surgery group and patients treated with non-surgical treatment with sling immobilization will be considered as the Conservative group Signed voluntary consent will be obtained from participants Patients having surgical fixation or nonoperative management will be assessed for kinesiophobia pain range of motion functional status and quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None