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

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.
 
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

Tracking Information
First Submitted Date  ICMJE February 13, 2009
First Posted Date  ICMJE February 18, 2009
Last Update Posted Date April 25, 2017
Study Start Date  ICMJE July 2008
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2010)
Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 6 month post surgery ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 1 year post surgery ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Range of Motion Following Arthroscopic Rotator Cuff Repair
Official Title  ICMJE The Effect of Early Range of Motion on Clinical Outcomes, Patient Satisfaction, and Cuff Integrity Following Arthroscopic Rotator Cuff Repair. A Prospective Randomized Study.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rotator Cuff Disease
Intervention  ICMJE
  • Other: Early motion
    Early referral to physical therapy for range of motion (2 days post)
  • Other: Standard motion
    Standard referral to physical therapy for range of motion (4 weeks post)
Study Arms  ICMJE
  • Early motion
    Intervention: Other: Early motion
  • Standard motion
    Intervention: Other: Standard motion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2017)
73
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2009)
70
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00845715
Other Study ID Numbers  ICMJE 08-311-3
DF08-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Augustus Mazzocca, UConn Health
Study Sponsor  ICMJE UConn Health
Collaborators  ICMJE Donaghue Medical Research Foundation
Investigators  ICMJE
Principal Investigator: Augustus D Mazzocca UConn Health
PRS Account UConn Health
Verification Date April 2017

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