Distal Clavicle Resection With Rotator Cuff Repair
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acromioclavicular Joint Arthritis |
Procedure: distal clavicle resection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Distal Clavicle Resection of Symptomatic Acromioclavicular Joint Arthritis Combined With Rotator Cuff Tear. Prospective Randomized Trial |
- the presence of acromioclavicular joint tenderness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- American Shoulder and Elbow Surgeons score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
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Procedure: distal clavicle resection
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
medium sized rotator cuff tears
Inclusion Criteria:
- rotator-cuff tear requiring repair
- acromioclavicular joint tenderness more than moderate(Pain Visual Analogue Scale 4-7)
- acromioclavicular arthritis(Petersson Grade II-III)
Exclusion Criteria:
- Arthritic changes of glenohumeral joint
- Combined infection
- Mini-open, open procedures
- Complete subscapularis tear
- Incomplete repair
- Neurologic abnormality including axillary nerve
- Adhesive capsulitis
- Prior surgery, trauma, or infection on shoulder girdle
- SLAP lesion or biceps tendon lesion without rotator-cuff tear or impingement syndrome
Contacts and Locations| Contact: Jae Chul Yoo, MD | 821099333501 | shoulderyoo@gmail.com |
| Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Jae chul Yoo, MD 821099333501 shoulderyoo@gmail.com | |
| Principal Investigator: Jae Chul Yoo, MD | |
| Principal Investigator: Kyoung Hwan Koh, MD | |
| Principal Investigator: | Jae Chul Yoo, MD | Samsung Medical Center |
More Information
Publications:
| Responsible Party: | Jae Chul Yoo, MD, Samsung Medical center |
| ClinicalTrials.gov Identifier: | NCT01040065 History of Changes |
| Other Study ID Numbers: | 2008-08-002 |
| Study First Received: | December 23, 2009 |
| Last Updated: | June 28, 2011 |
| Health Authority: | Korea: Ministry for Health, Welfare and Family Affairs |
Keywords provided by Samsung Medical Center:
|
Acromioclavicular joint arthritis distal clavicle resection Mumford procedure |
Additional relevant MeSH terms:
|
Arthritis Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013