Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact

NCT ID: NCT00891566

Last Updated: 2011-05-24

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

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rotator Cuff Tear

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Immobilization

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
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

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type RESULT
PMID: 16607589 (View on PubMed)

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.

Reference Type RESULT
PMID: 11347400 (View on PubMed)

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.

Reference Type RESULT
PMID: 16012501 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24647511 (View on PubMed)

Other Identifiers

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2008-04-051

Identifier Type: -

Identifier Source: org_study_id

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