Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Early Range of Motion Following Arthroscopic Rotator Cuff Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by University of Connecticut Health Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Augustus Mazzocca, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00845715
First received: February 13, 2009
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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 Intervention
Rotator Cuff Disease
Other: Early motion
Other: Standard motion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 6 month post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845715

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
Donaghue Medical Research Foundation
Investigators
Principal Investigator: Augustus D Mazzocca University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Augustus Mazzocca, Professor, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00845715     History of Changes
Other Study ID Numbers: 08-311-3, DF08-13
Study First Received: February 13, 2009
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
rotator cuff
rehabilitation
range of motion

ClinicalTrials.gov processed this record on November 23, 2014