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Postoperative Multiparameter Outcomes During the Six Months After Rotator Cuff Repair

This study is not yet open for participant recruitment.
Verified May 2012 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01608997
First received: May 29, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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.


Condition
Shoulder Pain
Quality of Life
Satisfaction

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Shoulder Function [ Time Frame: Six Months ] [ Designated as safety issue: No ]
    Outcome measurements will be collected through the use of the Quick Disability of Arm Shoulder and Hand Score (QuickDASH) questionnaire.

  • Quality of Life [ Time Frame: Six Months ] [ Designated as safety issue: No ]
    Outcome measurements will be collected through the use of the Twelve Item Health Status Survey (SF12)


Secondary Outcome Measures:
  • Self-Rated Improvement, Expectations and Satisfaction [ Time Frame: Six Months ] [ Designated as safety issue: No ]
    Outcome measurements will be collected through the use of the Patient Global Rating of Change Questionnaire

  • Range of Motion of the Shoulder [ Time Frame: Six Months ] [ Designated as safety issue: No ]
    Outcome will be measured through the use of a digital inclinometer

  • Isometric strength around the shoulder [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Outcome will be measured by a hand-held dynamometer (HHD)


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Candidates for rotator cuff repair due to shoulder pain and tears

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608997

Contacts
Contact: Ayelet Yahav Galkin, BPT 972-542644500 yahavgalkin@gmail.com

Locations
Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01608997     History of Changes
Other Study ID Numbers: 0071-11-HYMC
Study First Received: May 29, 2012
Last Updated: May 29, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
 Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013