Postoperative Multiparameter Outcomes During the Six Months After Rotator Cuff Repair

• Conditions: Shoulder Pain; Quality of Life; Satisfaction

• Registration Number: NCT01608997
• Lead Sponsor: Hillel Yaffe Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-05
• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-29
• Last Update Submitted: 2012-05-29
• Study First Posted: 2012-05-31
• Last Update Posted: 2012-05-31
• Study Start: 2012-06
• Primary Completion: 2013-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shoulder Function	Six Months	Outcome measurements will be collected through the use of the Quick Disability of Arm Shoulder and Hand Score (QuickDASH) questionnaire.
Quality of Life	Six Months	Outcome measurements will be collected through the use of the Twelve Item Health Status Survey (SF12)

Secondary Outcome Measures

Name	Time	Method
Self-Rated Improvement, Expectations and Satisfaction	Six Months	Outcome measurements will be collected through the use of the Patient Global Rating of Change Questionnaire
Range of Motion of the Shoulder	Six Months	Outcome will be measured through the use of a digital inclinometer
Isometric strength around the shoulder	Six months	Outcome will be measured by a hand-held dynamometer (HHD)

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel