Dislocation of the Acromioclavicular JointNCT04532216
The Clinical and Biomechanical Research of the New Arthroscopic Technique for the Treatment of High-grade Dislocation of the Acromioclavicular Joint
A study testing Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope Device and Traditional surgery in people with Dislocation of the Acromioclavicular Joint, run by Beijing Jishuitan Hospital.
Trial summary
Acromioclavicular joint dislocation is a common disease in shoulder surgery, which mostly occurs in young and middle-aged patients. Severe acromioclavicular joint dislocations of Rockwood type IV, V, and VI require surgical treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dislocation of the Acromioclavicular Joint
- What is being tested?
- Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope Device and Traditional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consecutive cases of coracoclavicular ligament reconstruction surgery usingTightRope Device With Allograft Augmentation and shoulder arthroscopic reconstruction of coracoclavicular ligament with autologous/allogeneic tendon transplantation.
- Injury type Rockwood type IV and V type severe acromioclavicular joint dislocation
- The time from injury to operation is less than 3 weeks
Who cannot join
- Combined with neurovascular injury
- Previous history of ipsilateral shoulder surgery
- The patient refused to sign the informed consent and participate in the trial
Trial locations and contacts
No sites are listed yet.
About this study
Acromioclavicular joint dislocation is a common disease in shoulder surgery, which mostly occurs in young and middle-aged patients. Severe acromioclavicular joint dislocations of Rockwood type IV, V, and VI require surgical treatment. Among them, the common clinical type IV and type V severe acromioclavicular joint dislocations are often treated with autologous/allogenous tendon transplantation and coracoclavicular ligament reconstruction under shoulder arthroscopy. Although this minimally invasive surgical method has certain advantages over incision surgery, due to factors such as poor healing after tendon transplantation and failure of coracoclavicular fixation, the recurrence rate of postoperative dislocation is still as high as 30%, which seriously affects the prognosis of patients. Therefore, we proposed a new surgical technique of minimally invasive shoulder arthroscopic coracoclavicular suspension fixation and coracoclavicular ligament residual reconstruction, which aims to strengthen the fixation strength of the coracoclavicular space, promote the healing of the coracoclavicular ligament, and reduce the recurrence rate of postoperative dislocation. To improve postoperative shoulder joint function of patients. This project intends to use non-randomized controlled clinical research and biomechanical research to compare traditional surgical techniques with new microscopic techniques in terms of surgical efficacy, postoperative complications, and internal plant fixation strength to establish the therapeutic advantages of the new technology. Its application and promotion provide important clinical evidence to improve the treatment of severe acromioclavicular joint dislocation in the field of shoulder surgery.
- Being tested
- Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope Device, Traditional surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope DeviceProcedure or surgery
Arthroscopic-assisted AC joint reconstruction with the TightRope device with allograft augmentation and with the patient in the lateral decubitus position is a method of restoring joint stability
Traditional surgeryProcedure or surgery
Tendon transfer
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Procedure: Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope Device |
| Control group | Other | Not described Receives: Procedure: Traditional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASES score
The ASES score is a 10-item measure of shoulder pain and function
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dislocation of the 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Jiang, Beijing Jishuitan Hospital
- Investigators
- Chunyan Jiang, Study chair, Sports Medicine Service, Beijing Jishuitan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532216
- Sponsor's protocol ID
- CJiang
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Biomechanical Research of the New Arthroscopic Technique for the Treatment of High-grade Dislocation of the Acromioclavicular Joint
- ClinicalTrials.gov ID
- NCT04532216
- Acronym / sponsor ID
- CJiang
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 31 Aug 2020 (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.
Acromioclavicular joint dislocation is a common disease in shoulder surgery, which mostly occurs in young and middle-aged patients. Severe acromioclavicular joint dislocations of Rockwood type IV, V, and VI require surgical treatment. Among them, the common clinical type IV and type V severe acromioclavicular joint dislocations are often treated with autologous/allogenous tendon transplantation and coracoclavicular ligament reconstruction under shoulder arthroscopy. Although this minimally invasive surgical method has certain advantages over incision surgery, due to factors such as poor healing after tendon transplantation and failure of coracoclavicular fixation, the recurrence rate of postoperative dislocation is still as high as 30%, which seriously affects the prognosis of patients. Therefore, we proposed a new surgical technique of minimally invasive shoulder arthroscopic coracoclavicular suspension fixation and coracoclavicular ligament residual reconstruction, which aims to strengthen the fixation strength of the coracoclavicular space, promote the healing of the coracoclavicular ligament, and reduce the recurrence rate of postoperative dislocation. To improve postoperative shoulder joint function of patients. This project intends to use non-randomized controlled clinical research and biomechanical research to compare traditional surgical techniques with new microscopic techniques in terms of surgical efficacy, postoperative complications, and internal plant fixation strength to establish the therapeutic advantages of the new technology. Its application and promotion provide important clinical evidence to improve the treatment of severe acromioclavicular joint dislocation in the field of shoulder surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope Device |
| Control group | Other | Procedure: Traditional surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive cases of coracoclavicular ligament reconstruction surgery usingTightRope Device With Allograft Augmentation and shoulder arthroscopic reconstruction of coracoclavicular ligament with autologous/allogeneic tendon transplantation.
- Injury type Rockwood type IV and V type severe acromioclavicular joint dislocation
- The time from injury to operation is less than 3 weeks
Key exclusion criteria (3 listed)
- Combined with neurovascular injury
- Previous history of ipsilateral shoulder surgery
- The patient refused to sign the informed consent and participate in the trial
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 |
|---|---|---|
| Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope DeviceArthroscopic-assisted AC joint reconstruction with the TightRope device with allograft augmentation and with the patient in the lateral decubitus position is a method of restoring joint stability | Procedure or surgery | Study group |
| Traditional surgeryTendon transfer | Procedure or surgery | Control group |
Primary outcome
ASES score
Time frame: 1 year postoperatively
The ASES score is a 10-item measure of shoulder pain and function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Chunyan Jiang study chair
Sports Medicine Service, Beijing Jishuitan hospital
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope Device and Traditional surgery in people with Dislocation of the Acromioclavicular Joint, run by Beijing Jishuitan Hospital.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhijun Zhang, M.D. (+86 15201277648, zzj5285029@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASES score (time frame: 1 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2020.