Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444828
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2023-11-30
Brief Title:
Comparing Outcomes of Non-surgical Versus Surgical Treatment of Shoulder Fractures With Different Shoulder Replacements
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
Outcome Following Reverse Shoulder Arthroplasty for Acute Proximal Humerus Fractures in Patients 60 Years of Age and Older With Different Inclination Implants Versus Non-surgical Treatment- Trial Protocol a Prospective RCT Single Blinded
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 optimal treatment of complex shoulder fracture is controversial In general non-surgical treatment is recommended for older patients but results are often unsatisfying Therefore different surgical approaches have been tried to improve outcomes for this group of patients Reverse shoulder arthroplasty has shown promising results for these types of fractures and changes in the design of the implant might improve outcomes further The aim of this study is to compare the outcomes of complex shoulder fractures after non-surgical versus surgical treatment and compare two different types of implants
Detailed Description:
The optimal treatment of proximal humeral fracture PHF Neer type III and IV AO B1112 and C1131 is controversial National guidelines for Denmark have been published in 2015 and updated 2019 They recommend conservative treatment to all kinds of PHF for patients aged above 60 years Exceptions are fracture-dislocations headsplits or surgical conditions where intervention is mandatory like open fractures and impaired nerve- and circulation
Recently reverse shoulder arthroplasty RSA has gained expanding popularity in treating PHF Compared with osteosynthesis ORIF or hemiarthroplasty HA outcomes were superior The importance of tuberosity healing for good functional outcomes has lead to development of different implants and fixation techniques The original RSA design by Grammont with 155 degree inclination of the humeral stem was made for cuff-arthropathy This design moves the center of rotation in a medial direction and increase the tension on the tuberosities
In contrast anatomical designed humeral implants with 135 degree enables more anatomical refixation of the tuberosities with less tension and might reduce the risk of resorption or displacement of the fragments To implant a 155 degree RSA the surgeon has to remove parts of the rotator cuff to enable the sliding rotation On the other hand with a 135 degree inclination humeral component a cuff sparing technique is possible
The aim of this study is to compare outcomes of two different designed RSA stems versus conservative treatment of PHF Neer type III or IV AO BC
Recently reverse shoulder arthroplasty RSA has gained expanding popularity in treating PHF Compared with osteosynthesis ORIF or hemiarthroplasty HA outcomes were superior The importance of tuberosity healing for good functional outcomes has lead to development of different implants and fixation techniques The original RSA design by Grammont with 155 degree inclination of the humeral stem was made for cuff-arthropathy This design moves the center of rotation in a medial direction and increase the tension on the tuberosities
In contrast anatomical designed humeral implants with 135 degree enables more anatomical refixation of the tuberosities with less tension and might reduce the risk of resorption or displacement of the fragments To implant a 155 degree RSA the surgeon has to remove parts of the rotator cuff to enable the sliding rotation On the other hand with a 135 degree inclination humeral component a cuff sparing technique is possible
The aim of this study is to compare outcomes of two different designed RSA stems versus conservative treatment of PHF Neer type III or IV AO BC
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