Postoperative Multiparameter Outcomes During the Six Months After Rotator Cuff Repair

Quality of Life Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01608997
• Other study ID #: 0071-11-HYMC
• Status: Not yet recruiting
• Phase: N/A
• First received: May 29, 2012
• Last updated: May 29, 2012
• Start date: June 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2012
• Source: Hillel Yaffe Medical Center
• Contact: Ayelet Yahav Galkin, BPT
• Phone: 972-542644500
• Email: yahavgalkin[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Quality of Life
• Satisfaction
• Shoulder Pain

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Function	Outcome measurements will be collected through the use of the Quick Disability of Arm Shoulder and Hand Score (QuickDASH) questionnaire.	Six Months	No
Primary	Quality of Life	Outcome measurements will be collected through the use of the Twelve Item Health Status Survey (SF12)	Six Months	No
Secondary	Self-Rated Improvement, Expectations and Satisfaction	Outcome measurements will be collected through the use of the Patient Global Rating of Change Questionnaire	Six Months	No
Secondary	Range of Motion of the Shoulder	Outcome will be measured through the use of a digital inclinometer	Six Months	No
Secondary	Isometric strength around the shoulder	Outcome will be measured by a hand-held dynamometer (HHD)	Six months	No