We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Lopez Ovenza Juan Manuel, Hospital Italiano de Buenos Aires.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01502098
First Posted: December 30, 2011
Last Update Posted: January 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lopez Ovenza Juan Manuel, Hospital Italiano de Buenos Aires
December 24, 2011
December 30, 2011
January 10, 2012
January 2012
June 2013   (Final data collection date for primary outcome measure)
MRI [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01502098 on ClinicalTrials.gov Archive Site
  • 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.
  • WORC [ Time Frame: 1, 3, 6 months ]
  • ASES [ Time Frame: 1, 3, 6 months ]
  • Range of Motion [ Time Frame: 1, 3, 6 months ]
  • VAS of pain [ Time Frame: 1, 3, 6 months ]
    visual analogue scale of pain
Not Provided
Not Provided
 
Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair
Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair With Double Row Technique in Small or Medium Ruptures. Prospective, Comparative and Randomized.
The study aims to establish whether one month postoperative immobilization compared early passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double row technique has any healing significance.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Rotator Cuff Tear
  • Procedure: Postoperative early passive motion
    Shoulder exercises starting on the first postoperative day
  • Other: Sling
    Sling for 4 weeks
  • 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.
    Intervention: Procedure: Postoperative early passive motion
  • 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.
    Intervention: Other: Sling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
114
December 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients skeletally mature (older 18 years old)
  • Small or medium rupture of rotator cuff
  • Repaired with arthroscopic double row technique

Exclusion Criteria:

  • Impossibility to perform MRI (claustrophobic, pacemaker, heart or brain metallic implants)
  • AC arthritis with mumford procedure
  • Smokers
  • Diabetes
  • Postoperative complication (severe pain, thrombosis, infection)
  • Psychiatric disorder
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
 
NCT01502098
CEPI:1780
Yes
Not Provided
Not Provided
Lopez Ovenza Juan Manuel, Hospital Italiano de Buenos Aires
Hospital Italiano de Buenos Aires
Not Provided
Not Provided
Hospital Italiano de Buenos Aires
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP