Distal Clavicle Resection With Rotator Cuff Repair

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.

Study Overview

• Status: Unknown
• Conditions: Acromioclavicular Joint Arthritis
• Intervention / Treatment: Procedure: distal clavicle resection

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Jae chul Yoo, MD; Phone Number: 821099333501; Email: shoulderyoo@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Jae chul Yoo, MD; Phone Number: 821099333501; Email: shoulderyoo@gmail.com
    • Principal Investigator: Jae Chul Yoo, MD
    • Principal Investigator: Kyoung Hwan Koh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

medium sized rotator cuff tears

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the presence of acromioclavicular joint tenderness	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
American Shoulder and Elbow Surgeons score	2 years

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Jae Chul Yoo, MD, Samsung Medical Center

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: December 23, 2009
• First Submitted That Met QC Criteria: December 24, 2009
• First Posted (Estimate): December 25, 2009

Study Record Updates

• Last Update Posted (Estimate): June 29, 2011
• Last Update Submitted That Met QC Criteria: June 28, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Acromioclavicular joint arthritis; distal clavicle resection; Mumford procedure
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 2008-08-002