Early Range of Motion Following Arthroscopic Rotator Cuff Repair
This study is ongoing, but not recruiting participants.
Sponsor:
University of Connecticut Health Center
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
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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
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 May 19, 2013