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

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

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.

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

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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