Distal Clavicle Resection With Rotator Cuff Repair

NCT ID: NCT01040065

Last Updated: 2011-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-03-31

Brief Summary

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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

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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

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Acromioclavicular Joint Arthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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distal clavicle resection

Presence of tenderness at 2 years after surgery

Intervention Type PROCEDURE

Other Intervention Names

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mumford procedure

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical center

Principal Investigators

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Jae Chul Yoo, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae Chul Yoo, MD

Role: CONTACT

821099333501

Facility Contacts

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Jae chul Yoo, MD

Role: primary

821099333501

References

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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.

Reference Type RESULT
PMID: 10231099 (View on PubMed)

Kharrazi 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.

Reference Type RESULT
PMID: 17681199 (View on PubMed)

Kurta 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.

Reference Type RESULT
PMID: 16459853 (View on PubMed)

Other Identifiers

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2008-08-002

Identifier Type: -

Identifier Source: org_study_id

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