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OpenTrials
Completed

NCT Number: NCT00891566

Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

immobilization

Procedure

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

Primary outcomes

  1. repair integrity analysis using postoperative MRI

    Time frame: 6 months

Secondary outcomes

  1. American Shoulder and Elbow Surgeons' score

    Time frame: 2 year postoperatively

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
May 1, 2009
Registry last updated
May 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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