Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact

NCT00891566 | Completed

• 1 other identifier: 2008-04-051
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rotator Cuff Tear

Keywords

medium to large tear; rotator cuff tear; arthroscopic repair; repair integrity; immobilization

Outcome Measures

Primary Outcomes (1)

• repair integrity analysis using postoperative MRI

  6 months

Secondary Outcomes (1)

• American Shoulder and Elbow Surgeons' score

  2 year postoperatively

Interventions

Immobilization PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

medium to large size rotator cuff tears

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (4)

• 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. doi: 10.1055/s-2006-926476. German.

  PMID: 16607589 RESULT

• 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.

  PMID: 11347400 RESULT

• 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. doi: 10.1016/j.arthro.2005.04.109.

  PMID: 16012501 RESULT

• Koh KH, Lim TK, Shon MS, Park YE, Lee SW, Yoo JC. Effect of immobilization without passive exercise after rotator cuff repair: randomized clinical trial comparing four and eight weeks of immobilization. J Bone Joint Surg Am. 2014 Mar 19;96(6):e44. doi: 10.2106/JBJS.L.01741.

  PMID: 24647511 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: May 1, 2009
• Study Start: April 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: April 1, 2011
• Last Updated: May 24, 2011

Record last verified: 2011-05

Locations

KR (1)