Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair
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|ClinicalTrials.gov Identifier: NCT01502098|
Recruitment Status : Unknown
Verified January 2012 by Lopez Ovenza Juan Manuel, Hospital Italiano de Buenos Aires.
Recruitment status was: Recruiting
First Posted : December 30, 2011
Last Update Posted : January 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Procedure: Postoperative early passive motion Other: Sling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair With Double Row Technique in Small or Medium Ruptures. Prospective, Comparative and Randomized.|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||December 2013|
Active Comparator: Early passive motion
Pendulum exercises starting on the first postoperative day. The patients are instructed to commence passive range-of-motion exercises in the plane of the scapula with the assistance with the contralateral limb. Active motion exercises were not permitted until four weeks after surgery.
Procedure: Postoperative early passive motion
Shoulder exercises starting on the first postoperative day
No Intervention: Immobilization
Immobilization with sling during a month. Pendulum exercises starting on the fourth postoperative week. The patients are instructed to commence passive range-of-motion exercises in the plane of the scapula with the assistance with the contralateral limb. Active motion exercises.
Sling for 4 weeks
- MRI [ Time Frame: 6 months ]
- ASES (American Shoulder and Elbow Surgeons Subjective Shoulder Scale) [ Time Frame: 1, 3, 6 months ]The ASES is 100-point standardized shoulder-assessment self-report form, 50 points of which are derived from patient self-report of pain on a visual analog scale and 50 points of which are computed from a formula using the cumulative score of 10 activities of daily living derived using a four-point ordinal scale.
- Range of Motion [ Time Frame: 1, 3, 6 months ]
- VAS of pain [ Time Frame: 1, 3, 6 months ]visual analogue scale of pain
- WORC [ Time Frame: 1, 3, 6 months ]The Western Ontario Rotator Cuff Index (WORC) is a self-report questionnaire developed specifically to evaluate disability in persons with pathology of the rotator cuff of the shoulder.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502098
|Contact: Juan M. Lopez Ovenza, MDfirstname.lastname@example.org|
|Hospital Italiano de Buenos Aires||Recruiting|
|Buenos Aires, Argentina, 1118|
|Contact: Juan Manuel Lopez Ovenza, MD email@example.com|