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Trial record 1 of 1 for:    NCT00845715
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Early Range of Motion Following Arthroscopic Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT00845715
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Augustus Mazzocca, UConn Health

Brief Summary:
The purpose of this study is to investigate whether there is a difference in the quality of life, ability to return to functioning (back to everyday life), the amount of experienced pain in patients who immediately move their shoulder versus patient who delay moving their shoulder after arthroscopic rotator cuff repair. We are also interested in whether there is a difference in the healing rates between these two groups.

Condition or disease Intervention/treatment Phase
Rotator Cuff Disease Other: Early motion Other: Standard motion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Early Range of Motion on Clinical Outcomes, Patient Satisfaction, and Cuff Integrity Following Arthroscopic Rotator Cuff Repair. A Prospective Randomized Study.
Study Start Date : July 2008
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Early motion Other: Early motion
Early referral to physical therapy for range of motion (2 days post)

Standard motion Other: Standard motion
Standard referral to physical therapy for range of motion (4 weeks post)




Primary Outcome Measures :
  1. Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 6 month post surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who are between 18 years and 70 years of age
  • full thickness rotator cuff tear on ultrasound and MRI
  • failed conservative management

Exclusion Criteria:

  • concomitant pathology including massive rotator cuff tears that extend into the subscapularis or the teres minor and all co-existing labral pathology
  • history of neuromuscular or degenerative disease

Information from the National Library of Medicine

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): NCT00845715


Locations
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United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Donaghue Medical Research Foundation
Investigators
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Principal Investigator: Augustus D Mazzocca UConn Health
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Responsible Party: Augustus Mazzocca, Professor, UConn Health
ClinicalTrials.gov Identifier: NCT00845715    
Other Study ID Numbers: 08-311-3
DF08-13
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Keywords provided by Augustus Mazzocca, UConn Health:
rotator cuff
rehabilitation
range of motion