Acromioclavicular Joint DislocationNCT06019260
Open Versus Arthroscopic Assisted Treatment of Acute Acromioclavicular Joint Disruption Using Suture Button Device
An observational study of Acromioclavicular Joint Dislocation, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Acromioclavicular Joint Dislocation
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Oct 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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
Who may be able to join
- Age of 16 to 60 years
- Definite radiographic diagnosis of isolated Rockwood type IIIb(unstable), IV and type v acromioclavicular joint dislocation
- Time from injury to operation < 3 weeks
- Patient with complete at least 12-month follow-up assessments
Who cannot join
- . Age outside the range
- Open injury, old injury (≥ 3 weeks since injury)
- Injury caused by other diseases (tendinitis, metabolic, et al.), concurrent shoulder osteoarthritis, arthropathy or any fracture
- Any previous operation of the injured limb
- Incomplete data or follow-up < 12 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the 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 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
- Conditions
- Acromioclavicular Joint Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | open surgical repair using suture button device method in acute acromioclavicular joint disruption | |
| group 2 | arthroscopic assisted treatment of acute acromioclavicular joint disruption using suture button device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: preoperative, three month postoperative and six month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Jan 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acromioclavicular Joint DislocationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Adel Abdelmajeed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019260
- Sponsor's protocol ID
- Acute AC Joint disruption
- Status last verified
- Dec 2024
- First submitted
- 18 Jul 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeong JY, Chun YM. Treatment of acute high-grade acromioclavicular joint dislocation. Clin Shoulder Elb. 2020 Sep 1;23(3):159-165. doi: 10.5397/cise.2020.00150. eCollection 2020 Sep.
PubMed 33330252Vijayan S, Kulkarni MS, Jain CP, Shetty S, Aroor MN, Rao SK. Bifocal Stabilisation of Acute Acromioclavicular Joint Dislocation using Suture Anchor and Temporary K-Wires: A Retrospective Analysis. Malays Orthop J. 2022 Nov;16(3):104-112. doi: 10.5704/MOJ.2211.016.
PubMed 36589364Bezruchenko S, Dolhopolov O, Yarova M, Luchko R, Mazevych V. Clinical Evaluation and Instrumental Diagnostics in Acute Acromioclavicular Joint Dislocation. Ortop Traumatol Rehabil. 2022 Feb 28;24(1):1-12. doi: 10.5604/01.3001.0015.7800.
PubMed 35297375Liu X, Huangfu X, Zhao J. Arthroscopic treatment of acute acromioclavicular joint dislocation by coracoclavicular ligament augmentation. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1460-1466. doi: 10.1007/s00167-013-2800-9. Epub 2013 Dec 10.
PubMed 24318508Lu D, Wang T, Hong JJ, Chen H, Sun LJ. Acute acromioclavicular joint dislocation treated with tightrope : Mini-open versus percutaneous stabilization. Acta Orthop Belg. 2019 Dec;85(4):406-411.
PubMed 32374229
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Arthroscopic Assisted Treatment of Acute Acromioclavicular Joint Disruption Using Suture Button Device
- ClinicalTrials.gov ID
- NCT06019260
- Acronym / sponsor ID
- Acute AC Joint disruption
- Conditions
- Acromioclavicular Joint Dislocation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –open surgical repair using suture button device method in acute acromioclavicular joint disruption |
| group 2 | – | –arthroscopic assisted treatment of acute acromioclavicular joint disruption using suture button device |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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
Key inclusion criteria (4 listed)
- Age of 16 to 60 years
- Definite radiographic diagnosis of isolated Rockwood type IIIb(unstable), IV and type v acromioclavicular joint dislocation
- Time from injury to operation < 3 weeks
- Patient with complete at least 12-month follow-up assessments
Key exclusion criteria (5 listed)
- . Age outside the range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiological evaluation using the true anteroposterior view of the shoulder
Time frame: preoperative, three month postoperative and six month postoperative
Radiological evaluation using the true anteroposterior view of the shoulder and AC projection (10 cephalic tilt with the beam centered over the AC joint)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 33330252Jeong JY, Chun YM. Treatment of acute high-grade acromioclavicular joint dislocation. Clin Shoulder Elb. 2020 Sep 1;23(3):159-165. doi: 10.5397/cise.2020.00150. eCollection 2020 Sep.
- Background: PubMed 36589364Vijayan S, Kulkarni MS, Jain CP, Shetty S, Aroor MN, Rao SK. Bifocal Stabilisation of Acute Acromioclavicular Joint Dislocation using Suture Anchor and Temporary K-Wires: A Retrospective Analysis. Malays Orthop J. 2022 Nov;16(3):104-112. doi: 10.5704/MOJ.2211.016.
- Background: PubMed 35297375Bezruchenko S, Dolhopolov O, Yarova M, Luchko R, Mazevych V. Clinical Evaluation and Instrumental Diagnostics in Acute Acromioclavicular Joint Dislocation. Ortop Traumatol Rehabil. 2022 Feb 28;24(1):1-12. doi: 10.5604/01.3001.0015.7800.
- Background: PubMed 24318508Liu X, Huangfu X, Zhao J. Arthroscopic treatment of acute acromioclavicular joint dislocation by coracoclavicular ligament augmentation. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1460-1466. doi: 10.1007/s00167-013-2800-9. Epub 2013 Dec 10.
- Background: PubMed 32374229Lu D, Wang T, Hong JJ, Chen H, Sun LJ. Acute acromioclavicular joint dislocation treated with tightrope : Mini-open versus percutaneous stabilization. Acta Orthop Belg. 2019 Dec;85(4):406-411.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromioclavicular Joint Dislocation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Adel abdelmajeed, residant (01121650557, mohamedadel@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological evaluation using the true anteroposterior view of the shoulder (time frame: preoperative, three month postoperative and six month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019260, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.