Distal Clavicle Resection With Rotator Cuff Repair

Acromioclavicular Joint Arthritis Clinical Trial

Official title:

Distal Clavicle Resection of Symptomatic Acromioclavicular Joint Arthritis Combined With Rotator Cuff Tear. Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01040065
• Other study ID #: 2008-08-002
• Status: Recruiting
• Phase: N/A
• First received: December 23, 2009
• Last updated: June 28, 2011
• Start date: June 2008
• Est. completion date: March 2012

Study information

• Verified date: June 2011
• Source: Samsung Medical Center
• Contact: Jae Chul Yoo, MD
• Phone: 821099333501
• Email: shoulderyoo[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acromioclavicular Joint Arthritis
• Arthritis

Intervention

Procedure:
• distal clavicle resection
Presence of tenderness at 2 years after surgery

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Fischer BW, Gross RM, McCarthy JA, Arroyo JS. Incidence of acromioclavicular joint complications after arthroscopic subacromial decompression. Arthroscopy. 1999 Apr;15(3):241-8. — View Citation

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. — View Citation

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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the presence of acromioclavicular joint tenderness		2 years	No
Secondary	American Shoulder and Elbow Surgeons score		2 years	No