Acromioclavicular Joint ArthritisNCT01040065
Distal Clavicle Resection With Rotator Cuff Repair
An observational study of Acromioclavicular Joint Arthritis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether distal clavicle resection is effective treatments in patients with acromioclavicular joint pain accompanied by rotator cuff tear. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acromioclavicular Joint Arthritis
- What is being tested?
- distal clavicle resection
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2008to Mar 2012
- Phase
- Observational
- 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
Study population: medium sized rotator cuff tears
Who may be able to join
- rotator-cuff tear requiring repair
- acromioclavicular joint tenderness more than moderate(Pain Visual Analogue Scale 4-7)
- acromioclavicular arthritis(Petersson Grade II-III)
Who cannot join
- Arthritic changes of glenohumeral joint
- Combined infection
- Mini-open, open procedures
- Complete subscapularis tear
- Incomplete repair
- Neurologic abnormality including axillary nerve
Show all 9Show fewer
- Adhesive capsulitis
- Prior surgery, trauma, or infection on shoulder girdle
- SLAP lesion or biceps tendon lesion without rotator-cuff tear or impingement syndrome
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Jae chul Yoo, MD, 821099333501, shoulderyoo@gmail.com
Jae Chul Yoo, MD
About this study
Official title: Distal Clavicle Resection of Symptomatic Acromioclavicular Joint Arthritis Combined With Rotator Cuff Tear. Prospective Randomized Trial
The purpose of this study is to determine whether distal clavicle resection is effective treatments in patients with acromioclavicular joint pain accompanied by rotator cuff tear.
Read the detailed description
Today, acromioclavicular joint syndrome is itself rarely a cause for hospital visit, and the need for its treatment is even rarer. In comparison, patients who suffer rotator cuff tear accompanied by shoulder impingement syndrome often complain of acromioclavicular joint pain. However, often patients who complain of severe pain have no positive findings on X-ray or MRI, or any sign of impingement. On the other hand, there are patients with positive findings on X-ray or MRI who have only little pain. Even a patient who in the out-patient-department complained of acromioclavicular joint pain on pressure may feel pain on pressure in the physical exam performed for rotator cuff tear surgery. The opposite is very frequent as well, so it is often different depending on the time and the performer. In the literature, there are some authors who maintain that a distal clavicular resection must be done when surgery is used to treat the impingement syndrome, while on the other hand, there are those who endorse only complaining (an operation to trim the distal clavicle and the protruding part of adjust the plane acromion in order to level their plane), and also those who propose an all or none approach to either perform a distal clavicular resection or not at all. Thus, there are varying opinions depending on the authors; moreover, these are all observational studies, and none report on the rotator cuff tear injury. The authors of this study hypothesize and will prove that since the osteoarthritic change and pain of the acromioclavicular joint is secondary to impingement syndrome, distal clavicular resection on rotator cuff repair surgery will have no long term effect.
- Conditions
- Acromioclavicular Joint Arthritis
- Being tested
- distal clavicle resection
- Keywords
- Acromioclavicular joint arthritis, distal clavicle resection, Mumford procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distal clavicle resectionProcedure or surgery
Also called mumford procedure
Presence of tenderness at 2 years after surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
the presence of acromioclavicular joint tenderness
Measured: 2 years
Secondary outcomes (1)
American Shoulder and Elbow Surgeons score
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 posted25 Dec 2009 (estimated)
- Study startJun 2008
- Primary completionFeb 2010
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acromioclavicular Joint ArthritisStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jae Chul Yoo, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040065
- Sponsor's protocol ID
- 2008-08-002
- Status last verified
- Jun 2011
- First submitted
- 23 Dec 2009
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Fischer BW, Gross RM, McCarthy JA, Arroyo JS. Incidence of acromioclavicular joint complications after arthroscopic subacromial decompression. Arthroscopy. 1999 Apr;15(3):241-8. doi: 10.1016/s0749-8063(99)70028-9.
PubMed 10231099Kharrazi FD, Busfield BT, Khorshad DS. Acromioclavicular joint reoperation after arthroscopic subacromial decompression with and without concomitant acromioclavicular surgery. Arthroscopy. 2007 Aug;23(8):804-8. doi: 10.1016/j.arthro.2007.02.003.
PubMed 17681199Kurta I, Datir S, Dove M, Rahmatalla A, Wynn-Jones C, Maffulli N. The short term effects of a single corticosteroid injection on the range of motion of the shoulder in patients with isolated acromioclavicular joint arthropathy. Acta Orthop Belg. 2005 Dec;71(6):656-61.
PubMed 16459853
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Clavicle Resection of Symptomatic Acromioclavicular Joint Arthritis Combined With Rotator Cuff Tear. Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01040065
- Acronym / sponsor ID
- 2008-08-002
- Conditions
- Acromioclavicular Joint Arthritis
- Keywords
- Acromioclavicular joint arthritis, distal clavicle resection, Mumford procedure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2012 (estimated)
- First posted
- 25 Dec 2009 (estimated)
- 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 purpose of this study is to determine whether distal clavicle resection is effective treatments in patients with acromioclavicular joint pain accompanied by rotator cuff tear.
Detailed description
Today, acromioclavicular joint syndrome is itself rarely a cause for hospital visit, and the need for its treatment is even rarer. In comparison, patients who suffer rotator cuff tear accompanied by shoulder impingement syndrome often complain of acromioclavicular joint pain. However, often patients who complain of severe pain have no positive findings on X-ray or MRI, or any sign of impingement. On the other hand, there are patients with positive findings on X-ray or MRI who have only little pain. Even a patient who in the out-patient-department complained of acromioclavicular joint pain on pressure may feel pain on pressure in the physical exam performed for rotator cuff tear surgery. The opposite is very frequent as well, so it is often different depending on the time and the performer. In the literature, there are some authors who maintain that a distal clavicular resection must be done when surgery is used to treat the impingement syndrome, while on the other hand, there are those who endorse only complaining (an operation to trim the distal clavicle and the protruding part of adjust the plane acromion in order to level their plane), and also those who propose an all or none approach to either perform a distal clavicular resection or not at all. Thus, there are varying opinions depending on the authors; moreover, these are all observational studies, and none report on the rotator cuff tear injury. The authors of this study hypothesize and will prove that since the osteoarthritic change and pain of the acromioclavicular joint is secondary to impingement syndrome, distal clavicular resection on rotator cuff repair surgery will have no long term effect.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- medium sized rotator cuff tears
Key inclusion criteria (3 listed)
- rotator-cuff tear requiring repair
- acromioclavicular joint tenderness more than moderate(Pain Visual Analogue Scale 4-7)
- acromioclavicular arthritis(Petersson Grade II-III)
Key exclusion criteria (9 listed)
- Arthritic changes of glenohumeral joint
- Combined infection
- Mini-open, open procedures
- Complete subscapularis tear
- Incomplete repair
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 |
|---|---|---|
| distal clavicle resectionAlso: mumford procedurePresence of tenderness at 2 years after surgery | Procedure or surgery | – |
Primary outcome
the presence of acromioclavicular joint tenderness
Time frame: 2 years
1 secondary outcome
American Shoulder and Elbow Surgeons score
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
- Results publication: PubMed 10231099Fischer BW, Gross RM, McCarthy JA, Arroyo JS. Incidence of acromioclavicular joint complications after arthroscopic subacromial decompression. Arthroscopy. 1999 Apr;15(3):241-8. doi: 10.1016/s0749-8063(99)70028-9.
- Results publication: PubMed 17681199Kharrazi FD, Busfield BT, Khorshad DS. Acromioclavicular joint reoperation after arthroscopic subacromial decompression with and without concomitant acromioclavicular surgery. Arthroscopy. 2007 Aug;23(8):804-8. doi: 10.1016/j.arthro.2007.02.003.
- Results publication: PubMed 16459853Kurta I, Datir S, Dove M, Rahmatalla A, Wynn-Jones C, Maffulli N. The short term effects of a single corticosteroid injection on the range of motion of the shoulder in patients with isolated acromioclavicular joint arthropathy. Acta Orthop Belg. 2005 Dec;71(6):656-61.
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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.
Jae Chul Yoo, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromioclavicular Joint Arthritis, run by Samsung Medical Center at 1 site in South Korea.
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 9 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 Jun 2011. 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 South Korea. 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 Jae Chul Yoo, MD (821099333501, shoulderyoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the presence of acromioclavicular joint tenderness (time frame: 2 years). 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 NCT01040065, which also lists 3 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 29 Jun 2011.