- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00845715
Early Range of Motion Following Arthroscopic Rotator Cuff Repair
April 24, 2017 updated by: Augustus Mazzocca, UConn Health
The Effect of Early Range of Motion on Clinical Outcomes, Patient Satisfaction, and Cuff Integrity Following Arthroscopic Rotator Cuff Repair. A Prospective Randomized Study.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Farmington, Connecticut, United States, 06030
- University of Connecticut Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Western Ontario Rotator Cuff Index (WORC)
Time Frame: 6 month post surgery
|
6 month post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Augustus D Mazzocca, UConn Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
February 13, 2009
First Submitted That Met QC Criteria
February 17, 2009
First Posted (Estimate)
February 18, 2009
Study Record Updates
Last Update Posted (Actual)
April 25, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 08-311-3
- DF08-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rotator Cuff Disease
-
Parc de Salut MarHospital Clinic of Barcelona; Hospital Universitario Fundación Jiménez Díaz; Hospital... and other collaboratorsRecruitingShoulder Disease | Massive Rotator Cuff TearsSpain
-
Istanbul UniversityRecruiting
-
Seoul National University HospitalCompletedRotator Cuff DiseaseKorea, Republic of
-
Ullevaal University HospitalUniversity of OsloCompleted
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Bezmialem Vakif UniversityNot yet recruitingRotator Cuff Tears | Partial Tear of Rotator CuffTurkey
-
The Cleveland ClinicRecruitingRotator Cuff Tears | Rotator Cuff RepairsUnited States
-
Ivan WongCompletedRotator Cuff Injury | Full Thickness Rotator Cuff Tear | Rotator Cuff Syndrome | Disorder of Rotator Cuff | Skin Graft (Allograft) (Autograft) FailureCanada
-
Xiros LtdNot yet recruitingRotator Cuff Tear | Rotator Cuff Injuries | Rotator Cuff Tears | Rotator Cuff Tears of the Shoulder
Clinical Trials on Early motion
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Washington University School of MedicineCompleted
-
Washington University School of MedicineBarnes-Jewish HospitalCompletedRotator Cuff TearUnited States
-
The Cooper Health SystemCompletedRange of Motion | Elbow Fracture | ImmobilizationUnited States
-
Cliniques universitaires Saint-Luc- Université...TerminatedMultiple Organ Dysfunction Syndrome | SEPTIC SHOCK | SEPSIS SYNDROMEBelgium
-
The Cooper Health SystemRecruitingProximal Humeral Fracture | Reverse Total Shoulder ArthroplastyUnited States
-
Hospital Italiano de Buenos AiresUnknownRotator Cuff TearArgentina
-
Baylor College of MedicineActive, not recruitingPatellar DislocationUnited States
-
University of FloridaPerformance HealthWithdrawn
-
University of ManitobaUnknownZone 2 Flexor Tendon Lacerations of the HandCanada
-
McMaster UniversityHamilton Health Sciences CorporationWithdrawn