- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01608997
Postoperative Multiparameter Outcomes During the Six Months After Rotator Cuff Repair
May 29, 2012 updated by: Hillel Yaffe Medical Center
Rotator cuff tears are common amongst 50-60 year olds with no connection to their physical activity.
When symptomatic, the injury affects all aspects of general health, quality of life and function.
Surgical intervention is recommended only if conservative treatment fails.
The purpose of the surgical intervention is to reduce pain, and improve function while improving range of motion and muscle strength around the shoulder.
The purpose of the current study is to measure physical, functional, expectation, satisfaction and quality of life outcomes after rotator cuff repair surgery.
Another purpose is to learn the reproducibility components of the above outcomes.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ayelet Yahav Galkin, BPT
- Phone Number: 972-542644500
- Email: yahavgalkin@gmail.com
Study Locations
-
-
-
Hadera, Israel, 38100
- Hillel Yaffe Medical 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
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Candidates for rotator cuff repair due to shoulder pain and tears
Description
Inclusion Criteria:
- Patients with chronic tears in supraspinatus and infraspinatus tendon
- Symptoms of up to 12 months
- No relief from conservative treatment
- Complete or almost complete tears of up to 3cm
- Hebrew speakers
Exclusion Criteria:
- Previous trauma
- Shoulder Infection
- Recurrent dislocation
- Avascular necrosis
- Frozen shoulder
- Additional tears
- Otherwise healthy
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder Function
Time Frame: Six Months
|
Outcome measurements will be collected through the use of the Quick Disability of Arm Shoulder and Hand Score (QuickDASH) questionnaire.
|
Six Months
|
Quality of Life
Time Frame: Six Months
|
Outcome measurements will be collected through the use of the Twelve Item Health Status Survey (SF12)
|
Six Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Rated Improvement, Expectations and Satisfaction
Time Frame: Six Months
|
Outcome measurements will be collected through the use of the Patient Global Rating of Change Questionnaire
|
Six Months
|
Range of Motion of the Shoulder
Time Frame: Six Months
|
Outcome will be measured through the use of a digital inclinometer
|
Six Months
|
Isometric strength around the shoulder
Time Frame: Six months
|
Outcome will be measured by a hand-held dynamometer (HHD)
|
Six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2012
Primary Completion (Anticipated)
August 1, 2013
Study Completion (Anticipated)
August 1, 2013
Study Registration Dates
First Submitted
May 29, 2012
First Submitted That Met QC Criteria
May 29, 2012
First Posted (Estimate)
May 31, 2012
Study Record Updates
Last Update Posted (Estimate)
May 31, 2012
Last Update Submitted That Met QC Criteria
May 29, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0071-11-HYMC
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.
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