Acromioclavicular JointNCT07024056
Acute ACJ Dislocation Type (III&VI): CC Ligaments Reconstruction With AC Ligament Reconstruction vs. CC Ligaments Reconstruction With AC Temporary k Wire Fixation
A study testing coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction and coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation in people with Acromioclavicular Joint and Acromioclavicular Joint Dislocation, run by Benha University.
Trial summary
The aim of this study is to compare the clinical and radiographical outcome of patients treated by coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction versus coracoclavicular ligaments reconstruction acromioclavicular temporary k wire fixation in management of Acute AC… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acromioclavicular Joint, Acromioclavicular Joint Dislocation
- What is being tested?
- coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction and coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to Aug 2026
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age at least 18 years old.
- Acute AC dislocation Rockwood type VI.
- Acute AC dislocation Rockwood type III patients with pre-injury high level of activity (work or athletic activity).
- Patient is fit for surgery.
- Patient is willing to participate.
Who cannot join
- Chronic AC dislocation.
- AC dislocation Rockwood type (I, II, IV and VI).
- Previous surgery to the same shoulder, degenerative changes of the glenohumeral joint, shoulder infections, and concomitant neurologic diseases.
- Associated neurological disorders in the affected limb.
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
Official title: Acute Acromioclavicular Joint Dislocation Rockwood Type (III&VI): Coracoclavicular Ligaments Reconstruction Associated With Acromioclavicular Ligament Reconstruction Versus Coracoclavicular Ligaments Reconstruction With Acromioclavicular Temporary k Wire Fixation
The aim of this study is to compare the clinical and radiographical outcome of patients treated by coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction versus coracoclavicular ligaments reconstruction acromioclavicular temporary k wire fixation in management of Acute AC dislocation Rockwood type (III\&VI).
- Number of patients (20)
- Type of disease (AC dislocation Rockwood type (III\&VI)
- follow up period (6 months)
- type of study: this is a clinical research study
Read the detailed description
Acromioclavicular joint dislocation (ACD) is one of the most common shoulder injuries and is usually sports related. Acromioclavicular (AC) joint injuries account for about 12% of all shoulder injuries in clinical practice, a rate that increases to almost 40% in athletes participating in contact sports.
Epidemiological studies showed that most AC joint injuries occur in the third decade of life, and the gender distribution is 5:1 in favor of men. Acromioclavicular joint (ACJ) injuries have been reported to especially occur in 20- to 30-year-old male patients engaging in high-contact sports.
The mechanism of injury leading to AC joint dislocation can be direct or indirect. A direct force on the superior aspect of the acromion process, it happen due to fall onto the outer aspect of the shoulder, is the most common scenario. The acromioclavicular capsule-ligamentous structures fail with consecutive loading of the coraco-clavicular (CC) ligaments.
The Four components of the acromioclavicular (AC) capsular ligaments and the two components of the coracoclavicular (CC) ligaments contribute to AC joint stability depending upon the direction and magnitude of the force applied. The trapezoid ligament provides the major support against compressive loads applied along the axis of the clavicle and acts as a secondary restraint to superior translation. On the other hand, the conoid ligament contributes to both superior and anterior stability. Among the 4 AC capsular ligaments, the superior and posterior capsular ligaments, reinforced by the deltoid and trapezius muscle, are important due to their primary role in prevention of posterior translation. Despite the different contribution of each ligament on the stability of the AC joint, most current surgical techniques for complete AC joint dislocation focus on CC interval fixation to restore the CC ligaments.
Nonsurgical management is the mainstay of treatment for type I and II injuries, whereas surgery is usually recommended for type IV to VI injuries. The treatment for type III remains instead controversial as no clear treatment algorithm has been established.
Because of the distinct functional anatomy of the AC and CC ligaments, several studies provided good results focusing on anatomical surgical techniques that recreate those structures, rather than non-anatomical procedures that aim to improve function and stability regardless of restoration of anatomy of the torn ligaments. Although several anatomic reconstruction techniques are available, most of them showed promising results after conducting underpowered studies at short-term follow-up. Moreover, no gold standard has been identified yet.
Several surgical techniques have been described in the literature. Rockwood classified the early surgical treatments for AC joint instability into 4 groups: (1) AC ligament repairs, (2) CC ligaments repairs, (3) excision of the distal clavicle, and (4) dynamic muscle transfer. In addition, K-wires, screws, and plates have been used for temporary fixation of the AC joint. A better understanding of the anatomy and biomechanics of the AC joint and the coracoclavicular (CC) ligaments has led to advances in surgical techniques. Anatomic reconstructions using free grafts have become popular in recent years. In addition, arthroscopically assisted procedures using cortical fixation devices have become more popular.
- Being tested
- coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction, coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstructionProcedure or surgery
The Gracilis or SemiT graft will be harvested from the ipsilateral knee. An oblique skin incision will be made starting from the ACJ and extended distally towards the tip of coracoid process. 2 drill holes will be prepared on the superior cortex of the clavicle at the footprint of the original 2 ligaments, using a 4.5-mm drill bit. The 2 holes will be around 1 cm apart and the lateral hole was around 2 to 2.5 cm proximal to the distal end of the clavicle. Another 4.5 mm drill bit hole was created in the acromion. The graft exiting laterally around the coracoid will be then passed through the conoid tunnel from inferior to superior and then passed through the acromial tunnel from superior to inferior. The graft exiting the acromion tunnel will be passed through the trapezoid tunnel from superior to inferior. The two free ends of the hamstring graft will be tied to one another with Ethibond No.2 sutures
coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixationProcedure or surgery
Two 2.4-mm tunnels corresponding to the origins of the conoid and trapezoid ligaments will be created through the distal clavicle, approximately 1.5cm apart from each other. The distal tunnel will be 2.5cm away from the AC joint. After harvesting the Gracilis or Semitendinosus from the ipsilateral leg, the graft was prepared with no. 2 Ethibond sutures and passed beneath the coracoid. Both ends of the graft will be passed inside out through the tunnels after enlarging the tunnels by 4.5 drill bit making a figure of 8 sling. The AC joint will be provisionally reduced with two 1.5/1.8-mm smooth K-wires while keeping the graft ends under adequate manual tension. The ends of the graft will be sutured onto themselves and the surrounding soft tissues. The wound will be closed in layers.
| Study group | Role | What they receive |
|---|---|---|
| coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction | Active comparator | The Gracilis or SemiT graft will be harvested from the ipsilateral knee. The acromioclavicular joint will be exposed by the deltopectoral approach. A strap incision will be started from the acromioclavicular joint and extended distally towards the tip of coracoid process. 2 drill holes will be prepared on the superior cortex of the clavicle at the footprint of the original 2 ligaments, using a 4.5-mm drill bit. The 2 holes will be around 1.5 cm apart and the lateral hole was around 2 to 2.5 cm proximal to the distal end of the clavicle. Another 4.5 mm drill bit hole was created in the acromion. The graft exiting laterally around the coracoid is then passed through the conoid tunnel from inferior to superior and then passed through the acromial tunnel from superior to inferior to augment/reconstruct the AC joint capsule. The graft exiting the acromion tunnel is passed through the trapezoid tunnel from superior to inferior. The two free ends of the hamstring graft are tied together. Receives: Procedure: coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction |
| coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation | Active comparator | Two 2.4-mm tunnels corresponding to the origins of the conoid and trapezoid ligaments will be created through the distal clavicle, approximately 1.5cm apart from each other. The distal tunnel will be 2.5cm away from the AC joint. After harvesting the Gracilis or Semitendinosus from the ipsilateral leg, the graft was prepared with no. 2 Ethibond sutures and passed beneath the coracoid. Both ends of the graft will be passed inside out through the tunnels after enlarging the tunnels by 4.5 drill bit making a figure of 8 sling. The AC joint will be provisionally reduced with two 1.5/1.8-mm smooth K-wires while keeping the graft ends under adequate manual tension. The ends of the graft will be sutured onto themselves and the surrounding soft tissues. Receives: Procedure: coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
Redislocations. Other local complications, eg. infection.
Measured: 12 months after surgery.
Secondary outcomes (1)
Constant-Murley Score
Constant-Murley Score (range: 0-100). Higher scores indicate better shoulder function. Scores above 80 generally reflect excellent shoulder performance.
Measured: 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acromioclavicular JointStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ahmed ElSherif, Shebin El-Kom Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024056
- Sponsor's protocol ID
- ACJ disruption management
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Frantz T, Ramkumar PN, Frangiamore S, Jones G, Soloff L, Kvit A, Curriero FC, Schickendantz M. Epidemiology of acromioclavicular joint injuries in professional baseball: analysis from the Major League Baseball Health and Injury Tracking System. J Shoulder Elbow Surg. 2021 Jan;30(1):127-133. doi: 10.1016/j.jse.2020.04.029. Epub 2020 Jun 9.
PubMed 32778383Saccomanno MF, Fodale M, Capasso L, Cazzato G, Milano G. Reconstruction of the coracoclavicular and acromioclavicular ligaments with semitendinosus tendon graft: a pilot study. Joints. 2014 May 8;2(1):6-14. eCollection 2014 Jan-Mar.
PubMed 25606535Pallis M, Cameron KL, Svoboda SJ, Owens BD. Epidemiology of acromioclavicular joint injury in young athletes. Am J Sports Med. 2012 Sep;40(9):2072-7. doi: 10.1177/0363546512450162. Epub 2012 Jun 15.
PubMed 22707749Sirin E, Aydin N, Mert Topkar O. Acromioclavicular joint injuries: diagnosis, classification and ligamentoplasty procedures. EFORT Open Rev. 2018 Jul 17;3(7):426-433. doi: 10.1302/2058-5241.3.170027. eCollection 2018 Jul.
PubMed 30233818Nolte PC, Lacheta L, Dekker TJ, Elrick BP, Millett PJ. Optimal Management of Acromioclavicular Dislocation: Current Perspectives. Orthop Res Rev. 2020 Mar 5;12:27-44. doi: 10.2147/ORR.S218991. eCollection 2020.
PubMed 32184680Frank RM, Cotter EJ, Leroux TS, Romeo AA. Acromioclavicular Joint Injuries: Evidence-based Treatment. J Am Acad Orthop Surg. 2019 Sep 1;27(17):e775-e788. doi: 10.5435/JAAOS-D-17-00105.
PubMed 31008872Shin SJ, Campbell S, Scott J, McGarry MH, Lee TQ. Simultaneous anatomic reconstruction of the acromioclavicular and coracoclavicular ligaments using a single tendon graft. Knee Surg Sports Traumatol Arthrosc. 2014 Sep;22(9):2216-22. doi: 10.1007/s00167-013-2569-x. Epub 2013 Jul 11.
PubMed 23842800Xara-Leite F, Andrade R, Moreira PS, Coutinho L, Ayeni OR, Sevivas N, Espregueira-Mendes J. Anatomic and non-anatomic reconstruction improves post-operative outcomes in chronic acromio-clavicular instability: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2019 Dec;27(12):3779-3796. doi: 10.1007/s00167-019-05408-3. Epub 2019 Feb 26.
PubMed 30806755Moatshe G, Kruckeberg BM, Chahla J, Godin JA, Cinque ME, Provencher MT, LaPrade RF. Acromioclavicular and Coracoclavicular Ligament Reconstruction for Acromioclavicular Joint Instability: A Systematic Review of Clinical and Radiographic Outcomes. Arthroscopy. 2018 Jun;34(6):1979-1995.e8. doi: 10.1016/j.arthro.2018.01.016. Epub 2018 Mar 21.
PubMed 29573931Garofalo R, Ceccarelli E, Castagna A, Calvisi V, Flanagin B, Conti M, Krishnan SG. Open capsular and ligament reconstruction with semitendinosus hamstring autograft successfully controls superior and posterior translation for type V acromioclavicular joint dislocation. Knee Surg Sports Traumatol Arthrosc. 2017 Jul;25(7):1989-1994. doi: 10.1007/s00167-017-4509-7. Epub 2017 Apr 22.
PubMed 28434037
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Acromioclavicular Joint Dislocation Rockwood Type (III&VI): Coracoclavicular Ligaments Reconstruction Associated With Acromioclavicular Ligament Reconstruction Versus Coracoclavicular Ligaments Reconstruction With Acromioclavicular Temporary k Wire Fixation
- ClinicalTrials.gov ID
- NCT07024056
- Acronym / sponsor ID
- ACJ disruption management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 17 Jun 2025 (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.
The aim of this study is to compare the clinical and radiographical outcome of patients treated by coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction versus coracoclavicular ligaments reconstruction acromioclavicular temporary k wire fixation in management of Acute AC dislocation Rockwood type (III\&VI).
- Number of patients (20)
- Type of disease (AC dislocation Rockwood type (III\&VI)
- follow up period (6 months)
- type of study: this is a clinical research study
Detailed description
Acromioclavicular joint dislocation (ACD) is one of the most common shoulder injuries and is usually sports related. Acromioclavicular (AC) joint injuries account for about 12% of all shoulder injuries in clinical practice, a rate that increases to almost 40% in athletes participating in contact sports.
Epidemiological studies showed that most AC joint injuries occur in the third decade of life, and the gender distribution is 5:1 in favor of men. Acromioclavicular joint (ACJ) injuries have been reported to especially occur in 20- to 30-year-old male patients engaging in high-contact sports.
The mechanism of injury leading to AC joint dislocation can be direct or indirect. A direct force on the superior aspect of the acromion process, it happen due to fall onto the outer aspect of the shoulder, is the most common scenario. The acromioclavicular capsule-ligamentous structures fail with consecutive loading of the coraco-clavicular (CC) ligaments.
The Four components of the acromioclavicular (AC) capsular ligaments and the two components of the coracoclavicular (CC) ligaments contribute to AC joint stability depending upon the direction and magnitude of the force applied. The trapezoid ligament provides the major support against compressive loads applied along the axis of the clavicle and acts as a secondary restraint to superior translation. On the other hand, the conoid ligament contributes to both superior and anterior stability. Among the 4 AC capsular ligaments, the superior and posterior capsular ligaments, reinforced by the deltoid and trapezius muscle, are important due to their primary role in prevention of posterior translation. Despite the different contribution of each ligament on the stability of the AC joint, most current surgical techniques for complete AC joint dislocation focus on CC interval fixation to restore the CC ligaments.
Nonsurgical management is the mainstay of treatment for type I and II injuries, whereas surgery is usually recommended for type IV to VI injuries. The treatment for type III remains instead controversial as no clear treatment algorithm has been established.
Because of the distinct functional anatomy of the AC and CC ligaments, several studies provided good results focusing on anatomical surgical techniques that recreate those structures, rather than non-anatomical procedures that aim to improve function and stability regardless of restoration of anatomy of the torn ligaments. Although several anatomic reconstruction techniques are available, most of them showed promising results after conducting underpowered studies at short-term follow-up. Moreover, no gold standard has been identified yet.
Several surgical techniques have been described in the literature. Rockwood classified the early surgical treatments for AC joint instability into 4 groups: (1) AC ligament repairs, (2) CC ligaments repairs, (3) excision of the distal clavicle, and (4) dynamic muscle transfer. In addition, K-wires, screws, and plates have been used for temporary fixation of the AC joint. A better understanding of the anatomy and biomechanics of the AC joint and the coracoclavicular (CC) ligaments has led to advances in surgical techniques. Anatomic reconstructions using free grafts have become popular in recent years. In addition, arthroscopically assisted procedures using cortical fixation devices have become more popular.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction | Active comparator | Procedure: coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstructionThe Gracilis or SemiT graft will be harvested from the ipsilateral knee. The acromioclavicular joint will be exposed by the deltopectoral approach. A strap incision will be started from the acromioclavicular joint and extended distally towards the tip of coracoid process. 2 drill holes will be prepared on the superior cortex of the clavicle at the footprint of the original 2 ligaments, using a 4.5-mm drill bit. The 2 holes will be around 1.5 cm apart and the lateral hole was around 2 to 2.5 cm proximal to the distal end of the clavicle. Another 4.5 mm drill bit hole was created in the acromion. The graft exiting laterally around the coracoid is then passed through the conoid tunnel from inferior to superior and then passed through the acromial tunnel from superior to inferior to augment/reconstruct the AC joint capsule. The graft exiting the acromion tunnel is passed through the trapezoid tunnel from superior to inferior. The two free ends of the hamstring graft are tied together. |
| coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation | Active comparator | Procedure: coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixationTwo 2.4-mm tunnels corresponding to the origins of the conoid and trapezoid ligaments will be created through the distal clavicle, approximately 1.5cm apart from each other. The distal tunnel will be 2.5cm away from the AC joint. After harvesting the Gracilis or Semitendinosus from the ipsilateral leg, the graft was prepared with no. 2 Ethibond sutures and passed beneath the coracoid. Both ends of the graft will be passed inside out through the tunnels after enlarging the tunnels by 4.5 drill bit making a figure of 8 sling. The AC joint will be provisionally reduced with two 1.5/1.8-mm smooth K-wires while keeping the graft ends under adequate manual tension. The ends of the graft will be sutured onto themselves and the surrounding soft tissues. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age at least 18 years old.
- Acute AC dislocation Rockwood type VI.
- Acute AC dislocation Rockwood type III patients with pre-injury high level of activity (work or athletic activity).
- Patient is fit for surgery.
- Patient is willing to participate.
Key exclusion criteria (4 listed)
- Chronic AC dislocation.
- AC dislocation Rockwood type (I, II, IV and VI).
- Previous surgery to the same shoulder, degenerative changes of the glenohumeral joint, shoulder infections, and concomitant neurologic diseases.
- Associated neurological disorders in the affected limb.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstructionThe Gracilis or SemiT graft will be harvested from the ipsilateral knee. An oblique skin incision will be made starting from the ACJ and extended distally towards the tip of coracoid process. 2 drill holes will be prepared on the superior cortex of the clavicle at the footprint of the original 2 ligaments, using a 4.5-mm drill bit. The 2 holes will be around 1 cm apart and the lateral hole was around 2 to 2.5 cm proximal to the distal end of the clavicle. Another 4.5 mm drill bit hole was created in the acromion. The graft exiting laterally around the coracoid will be then passed through the conoid tunnel from inferior to superior and then passed through the acromial tunnel from superior to inferior. The graft exiting the acromion tunnel will be passed through the trapezoid tunnel from superior to inferior. The two free ends of the hamstring graft will be tied to one another with Ethibond No.2 sutures | Procedure or surgery | coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction |
| coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixationTwo 2.4-mm tunnels corresponding to the origins of the conoid and trapezoid ligaments will be created through the distal clavicle, approximately 1.5cm apart from each other. The distal tunnel will be 2.5cm away from the AC joint. After harvesting the Gracilis or Semitendinosus from the ipsilateral leg, the graft was prepared with no. 2 Ethibond sutures and passed beneath the coracoid. Both ends of the graft will be passed inside out through the tunnels after enlarging the tunnels by 4.5 drill bit making a figure of 8 sling. The AC joint will be provisionally reduced with two 1.5/1.8-mm smooth K-wires while keeping the graft ends under adequate manual tension. The ends of the graft will be sutured onto themselves and the surrounding soft tissues. The wound will be closed in layers. | Procedure or surgery | coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation |
Primary outcome
complications
Time frame: 12 months after surgery.
Redislocations. Other local complications, eg. infection.
1 secondary outcome
Constant-Murley Score
Time frame: 12 months after surgery.
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 22 Jun 2025.
- Background: PubMed 32778383Frantz T, Ramkumar PN, Frangiamore S, Jones G, Soloff L, Kvit A, Curriero FC, Schickendantz M. Epidemiology of acromioclavicular joint injuries in professional baseball: analysis from the Major League Baseball Health and Injury Tracking System. J Shoulder Elbow Surg. 2021 Jan;30(1):127-133. doi: 10.1016/j.jse.2020.04.029. Epub 2020 Jun 9.
- Background: PubMed 25606535Saccomanno MF, Fodale M, Capasso L, Cazzato G, Milano G. Reconstruction of the coracoclavicular and acromioclavicular ligaments with semitendinosus tendon graft: a pilot study. Joints. 2014 May 8;2(1):6-14. eCollection 2014 Jan-Mar.
- Background: PubMed 22707749Pallis M, Cameron KL, Svoboda SJ, Owens BD. Epidemiology of acromioclavicular joint injury in young athletes. Am J Sports Med. 2012 Sep;40(9):2072-7. doi: 10.1177/0363546512450162. Epub 2012 Jun 15.
- Background: PubMed 30233818Sirin E, Aydin N, Mert Topkar O. Acromioclavicular joint injuries: diagnosis, classification and ligamentoplasty procedures. EFORT Open Rev. 2018 Jul 17;3(7):426-433. doi: 10.1302/2058-5241.3.170027. eCollection 2018 Jul.
- Background: PubMed 32184680Nolte PC, Lacheta L, Dekker TJ, Elrick BP, Millett PJ. Optimal Management of Acromioclavicular Dislocation: Current Perspectives. Orthop Res Rev. 2020 Mar 5;12:27-44. doi: 10.2147/ORR.S218991. eCollection 2020.
- Background: PubMed 31008872Frank RM, Cotter EJ, Leroux TS, Romeo AA. Acromioclavicular Joint Injuries: Evidence-based Treatment. J Am Acad Orthop Surg. 2019 Sep 1;27(17):e775-e788. doi: 10.5435/JAAOS-D-17-00105.
- Results publication: PubMed 23842800Shin SJ, Campbell S, Scott J, McGarry MH, Lee TQ. Simultaneous anatomic reconstruction of the acromioclavicular and coracoclavicular ligaments using a single tendon graft. Knee Surg Sports Traumatol Arthrosc. 2014 Sep;22(9):2216-22. doi: 10.1007/s00167-013-2569-x. Epub 2013 Jul 11.
- Results publication: PubMed 30806755Xara-Leite F, Andrade R, Moreira PS, Coutinho L, Ayeni OR, Sevivas N, Espregueira-Mendes J. Anatomic and non-anatomic reconstruction improves post-operative outcomes in chronic acromio-clavicular instability: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2019 Dec;27(12):3779-3796. doi: 10.1007/s00167-019-05408-3. Epub 2019 Feb 26.
- Results publication: PubMed 29573931Moatshe G, Kruckeberg BM, Chahla J, Godin JA, Cinque ME, Provencher MT, LaPrade RF. Acromioclavicular and Coracoclavicular Ligament Reconstruction for Acromioclavicular Joint Instability: A Systematic Review of Clinical and Radiographic Outcomes. Arthroscopy. 2018 Jun;34(6):1979-1995.e8. doi: 10.1016/j.arthro.2018.01.016. Epub 2018 Mar 21.
- Results publication: PubMed 28434037Garofalo R, Ceccarelli E, Castagna A, Calvisi V, Flanagin B, Conti M, Krishnan SG. Open capsular and ligament reconstruction with semitendinosus hamstring autograft successfully controls superior and posterior translation for type V acromioclavicular joint dislocation. Knee Surg Sports Traumatol Arthrosc. 2017 Jul;25(7):1989-1994. doi: 10.1007/s00167-017-4509-7. Epub 2017 Apr 22.
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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?
A study testing coracoclavicular ligaments reconstruction associated with acromioclavicular ligament reconstruction and coracoclavicular ligaments reconstruction with acromioclavicular temporary k wire fixation in people with Acromioclavicular Joint and Acromioclavicular Joint Dislocation, run by Benha 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 5 inclusion and 4 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 22 Jun 2025. 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 Sherif Eltraigy, Ass. Prof. (+201221754037, shareefaltraigy@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications (time frame: 12 months after surgery.). 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 NCT07024056, which also lists 10 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 22 Jun 2025.