Acromioclavicular Joint DislocationNCT03060564
Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft
A study testing tendon graft in people with Acromioclavicular Joint Dislocation, run by Dr. Brian Lee at 1 site in United States.
Trial summary
To evaluate patient function, radiographic changes and complication rates of acute coracoclavicular (CC) joint reconstruction with and without the use of tendon graft as an augmentation to repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromioclavicular Joint Dislocation
- What is being tested?
- tendon graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Displaced acromioclavicular joint dislocation sustained within 3 weeks of surgery
- recommended for operative fixation
- age 18 years or older
Who cannot join
- Open dislocation
- previous acromioclavicular surgery
- unable to follow study protocol
- concomitant injury requiring surgery (rotator cuff repair, biceps tenotomy/tenodesis)
- active infection
- unable to follow postoperative rehabilitation guidelines
- reconstruction with coracoclavicular screw or hook plate.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Kerlan-Jobe Institute at White Memorial Hospital
Los Angeles, California, 90033
Chris Kelin, 310-423-3198
About this study
Official title: A Randomized, Prospective Trial Comparing Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft
To evaluate patient function, radiographic changes and complication rates of acute coracoclavicular (CC) joint reconstruction with and without the use of tendon graft as an augmentation to repair.
Read the detailed description
Acromioclavicular (AC) joint dislocations comprise up to 12% of shoulder girdle injuries. Many methods of reconstructing the coracoclavicular ligaments, which provide vertical stability of the acromioclavicular joint, have been described. The use of tendon graft to augment the reconstruction provides improved biomechanical stability, less radiographic changes postoperatively including loss of reduction, and improved function. However, the use of a tendon graft necessitates larger drill holes in the clavicle when compared to suture-only repair constructs. The size and placement of these tunnels in the clavicle have been associated with a higher rate of complications.
It has been shown that repairs in the setting of acute injury demonstrate less complications including loss of reduction when compared with chronic dislocations. However, other reports describing repair of acute AC joint dislocations without graft augmentation have described significant changes in coracoclavicular distance with routine follow up radiographs, and up to 90% implant migration rates. While use of tendon graft would be expected to provide further stability, they may in turn cause an increased complication rate.
- To determine complication rates in the reconstruction of AC joint dislocations with and without the use of tendon graft.
- Determine patient satisfaction, the ASES, Constant, SF-12, SANE, SST scores of shoulders that undergo reconstruction of acute AC joint dislocations with and without the use of graft.
- The investigation aims to determine whether or not graft should be used in the reconstruction of acute AC joint dislocations.
- Conditions
- Acromioclavicular Joint Dislocation
- Being tested
- tendon graft, No intervention
- Keywords
- shoulder, orthopaedics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tendon graftProcedure or surgery
JRF Orthopedics Tendon Graft
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| AC repair with tendon graft | Experimental | acromioclavicular repair with tendon graft. Receives: Procedure: tendon graft |
| AC repair with no tendon graft | Active comparator | acromioclavicular repair without tendon graft/no intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rates with and without the use of graft tendons
loss of radiographic reduction, infection, need for more surgery
Measured: 2 years
(American Shoulder Elbow Society (ASES)
Shoulder Function survey (17 multiple choice questions).
Measured: 2 years
Instability Index Constant Score (ISIS)
Shoulder Instability survey for last 4 weeks (yes/no and multiple choice). Score is graded poor, fair, good, excellent.
Measured: 2 years
Simple Shoulder Test (SST)
Shoulder Function survey (12 yes/no questions)
Measured: 2 years
Short Form-12
This survey assesses patient's health satisfaction. This information will help keep track of how patients feel and how well patients are able to do your usual activities. (12 multiple choice questions)
Measured: 2 years
Single Assessment Numerical Evaluation (SANE)
Patient assessment rating from 0-100 shoulder normality
Measured: 2 years
Visual Analog Score (VAS)
Measurement of shoulder pain from 0 (no pain) to 10 (unbearable distress)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2017
- Primary completionMar 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acromioclavicular Joint DislocationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Brian Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, Kerlan-Jobe Institute, White Memorial Hospital
- Responsible party
- Sponsor-investigator, Dr. Brian Lee, Cedars-Sinai Medical Center
- Investigators
- Brian Lee, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060564
- Sponsor's protocol ID
- Pro46696
- Status last verified
- Jan 2018
- First submitted
- 7 Feb 2017
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Trial Comparing Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft
- ClinicalTrials.gov ID
- NCT03060564
- Acronym / sponsor ID
- Pro46696
- Conditions
- Acromioclavicular Joint Dislocation
- Keywords
- shoulder, orthopaedics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dr. Brian LeeUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, Kerlan-Jobe Institute, White Memorial Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 23 Feb 2017 (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.
To evaluate patient function, radiographic changes and complication rates of acute coracoclavicular (CC) joint reconstruction with and without the use of tendon graft as an augmentation to repair.
Detailed description
Acromioclavicular (AC) joint dislocations comprise up to 12% of shoulder girdle injuries. Many methods of reconstructing the coracoclavicular ligaments, which provide vertical stability of the acromioclavicular joint, have been described. The use of tendon graft to augment the reconstruction provides improved biomechanical stability, less radiographic changes postoperatively including loss of reduction, and improved function. However, the use of a tendon graft necessitates larger drill holes in the clavicle when compared to suture-only repair constructs. The size and placement of these tunnels in the clavicle have been associated with a higher rate of complications.
It has been shown that repairs in the setting of acute injury demonstrate less complications including loss of reduction when compared with chronic dislocations. However, other reports describing repair of acute AC joint dislocations without graft augmentation have described significant changes in coracoclavicular distance with routine follow up radiographs, and up to 90% implant migration rates. While use of tendon graft would be expected to provide further stability, they may in turn cause an increased complication rate.
- To determine complication rates in the reconstruction of AC joint dislocations with and without the use of tendon graft.
- Determine patient satisfaction, the ASES, Constant, SF-12, SANE, SST scores of shoulders that undergo reconstruction of acute AC joint dislocations with and without the use of graft.
- The investigation aims to determine whether or not graft should be used in the reconstruction of acute AC joint dislocations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC repair with tendon graft | Experimental | Procedure: tendon graftacromioclavicular repair with tendon graft. |
| AC repair with no tendon graft | Active comparator | Other: No interventionacromioclavicular repair without tendon graft/no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Displaced acromioclavicular joint dislocation sustained within 3 weeks of surgery
- recommended for operative fixation
- age 18 years or older
Key exclusion criteria (7 listed)
- Open dislocation
- previous acromioclavicular surgery
- unable to follow study protocol
- concomitant injury requiring surgery (rotator cuff repair, biceps tenotomy/tenodesis)
- active infection
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 |
|---|---|---|
| tendon graftJRF Orthopedics Tendon Graft | Procedure or surgery | AC repair with tendon graft |
| No interventionNo intervention | Other | AC repair with no tendon graft |
Primary outcome
Complication Rates with and without the use of graft tendons
Time frame: 2 years
loss of radiographic reduction, infection, need for more surgery
(American Shoulder Elbow Society (ASES)
Time frame: 2 years
Shoulder Function survey (17 multiple choice questions).
Instability Index Constant Score (ISIS)
Time frame: 2 years
Shoulder Instability survey for last 4 weeks (yes/no and multiple choice). Score is graded poor, fair, good, excellent.
Simple Shoulder Test (SST)
Time frame: 2 years
Shoulder Function survey (12 yes/no questions)
Short Form-12
Time frame: 2 years
This survey assesses patient's health satisfaction. This information will help keep track of how patients feel and how well patients are able to do your usual activities. (12 multiple choice questions)
Single Assessment Numerical Evaluation (SANE)
Time frame: 2 years
Patient assessment rating from 0-100 shoulder normality
Visual Analog Score (VAS)
Time frame: 2 years
Measurement of shoulder pain from 0 (no pain) to 10 (unbearable distress)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- 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. This study is not recruiting at the moment.
Brian Lee, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tendon graft in people with Acromioclavicular Joint Dislocation, run by Dr. Brian Lee at 1 site in United States.
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 7 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Study Coordinator (3104233198, Christopher.Klein@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Rates with and without the use of graft tendons (time frame: 2 years). The study lists 7 primary outcomes in all. 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 29 Jan 2018.