An observational study in Acromioclavicular Joint Dislocation, sponsored by Assiut University. Not yet recruiting. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Assiut University · Observational
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
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 results.9 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
98 studies on the registry are indexed under Joint Dislocations; 21 are open to participants now.
This study's planned enrollment of 54 is below the median of 100 across 37 observational studies indexed under Joint Dislocations.
Browse Joint Dislocations studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients meeting the inclusion criteria and willing to take part in the study will be included investigators conducted an a priori test for sample size calculation using the G*Power 3.1.9.2 software. investigators assumed a CMS mean difference between the 2 groups of 16 points, a standard deviation of 20 points, an alpha of 0.05, and power (1 - b) of 80%; 21 subjects had to be included in each group. Our goal was to include 27 cases in each group to compensate for any lost subjects during the follow-up phase
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
. Age outside the range
open surgical repair using suture button device method in acute acromioclavicular joint disruption
arthroscopic assisted treatment of acute acromioclavicular joint disruption using suture button device
Radiological evaluation using the true anteroposterior view of the shoulder
Radiological evaluation using the true anteroposterior view of the shoulder and AC projection (10 cephalic tilt with the beam centered over the AC joint)
Time frame: preoperative, three month postoperative and six month postoperative
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jan 2025; primary completion for Sep 2025, 8 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.