Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06019260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-07-18
Brief Title:
Open Versus Arthroscopic Assisted Treatment of Acute Acromioclavicular Joint Disruption Using Suture Button Device
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Open Versus Arthroscopic Assisted Treatment of Acute Acromioclavicular Joint Disruption Using Suture Button Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
Compare the clinical and radiological outcome between the arthroscopic and open surgical repair using suture button device method in cases with acute AC joint disruption
Detailed Description:
Acromioclavicular AC joint dislocation is a common shoulder injury especially among athletes and has an estimated incidence of 17 of all shoulder injuries and30-50 of athletic shoulder injuries In most cases these are caused by a direct fall on the ipsilateral shoulder tip The indirect mechanism of injury with an extended arm is rare The Rockwood classification system is currently used and based on the degree and direction of the disrupted anatomy of the AC joint
Despite the high prevalence of this injury there is no consensus about its optimal treatment A variety of surgical procedures are described in the literature such as an augmented suture with absorbable materials stabilization with Kirschner K-wires in combination with or without additional wire loops hook plates or the Bosworth screw but none can be considered the gold standard of operative AC joint stabilization another treatment option was offered by the Tight Rope system This technique was developed as a minimally invasive procedure in the management of AC dislocations Because of its minimally invasive approach it reduces soft tissue damage and yields better cosmetic results9 Also there is no need for reoperation to remove the hardware that might screws or plates Moreover the complications of hardware failure like breakage dislocations or bone fractures are minimized
Despite the high prevalence of this injury there is no consensus about its optimal treatment A variety of surgical procedures are described in the literature such as an augmented suture with absorbable materials stabilization with Kirschner K-wires in combination with or without additional wire loops hook plates or the Bosworth screw but none can be considered the gold standard of operative AC joint stabilization another treatment option was offered by the Tight Rope system This technique was developed as a minimally invasive procedure in the management of AC dislocations Because of its minimally invasive approach it reduces soft tissue damage and yields better cosmetic results9 Also there is no need for reoperation to remove the hardware that might screws or plates Moreover the complications of hardware failure like breakage dislocations or bone fractures are minimized
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?:
False
Is an FDA AA801 Violation?:
None