Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact

Rotator Cuff Tear Clinical Trial

Official title:

Prolonged Versus Conventional Immobilization After Arthroscopic Repair for Medium to Large Size Rotator Cuff Tear. A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891566
• Other study ID #: 2008-04-051
• Status: Completed
• Phase: N/A
• First received: April 29, 2009
• Last updated: May 23, 2011
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• Source: Samsung Medical Center
• Contact: n/a
• 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 the immobilization period is helpful for the better healing of repaired rotator cuff.

The investigators hypothesis is that the longer immobilization after rotator cuff repair will help the healing of rotator cuff.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Medium to large sized cuff tear (2-4 cm)

• Yes subscapular partial fraying or longitudinal split side to side

• Yes acromioplasty

• Yes AC arthritis with mumford procedure

• Yes biceps tenotomy or tenodesis

Exclusion Criteria:

• No arthritic changes of glenohumeral joint

• No combined infection

• No mini-open procedures

• No complete subscapularis tear

• No incomplete repair

• No small tears or side to side repairs without anchors

• No pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

Procedure:
• Immobilization
compared the healing status for 8 weeks of immobilization with the conventional 4 weeks of immobilization after rotator cuff repair

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)

Kim SH, Yoo JC, Ahn JM. Arthroscopically repaired Bankart lesions and the effect of two different arm positions on immediate postoperative evaluation with magnetic resonance arthrography. Arthroscopy. 2005 Jul;21(7):867-74. — View Citation

Lewis CW, Schlegel TF, Hawkins RJ, James SP, Turner AS. The effect of immobilization on rotator cuff healing using modified Mason-Allen stitches: a biomechanical study in sheep. Biomed Sci Instrum. 2001;37:263-8. — View Citation

Pennekamp W, Gekle C, Nicolas V, Seybold D. [Initial results of shoulder MRI in external rotation after primary shoulder dislocation and after immobilization in external rotation]. Rofo. 2006 Apr;178(4):410-5. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	repair integrity analysis using postoperative MRI		6 months	No
Secondary	American Shoulder and Elbow Surgeons' score		2 year postoperatively	No