Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair (WORC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01532492|
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : May 1, 2014
Arthroscopic rotator cuff repair is described as being a successful procedure. These results are often derived from clinical general shoulder examinations, which are then classified as 'excellent', 'good', 'fair' or 'poor'. However, the cut-off points for these classifications vary and sometimes modified scores are used.
Arthroscopic rotator cuff repair is performed to improve quality of life. Therefore, disease specific health-related quality of life patient-administered questionnaires are needed. The WORC is a quality of life questionnaire designed for patients with disorders of the rotator cuff. The score is validated for rotator cuff disease, but not for rotator cuff repair specifically.
The aim of this study is to investigate reliability, validity and responsiveness of WORC in patients undergoing arthroscopic rotator cuff repair.
|Condition or disease|
|Rotator Cuff Lesion Disorder of Rotator Cuff Other Instability, Shoulder|
An approved translation of the WORC into Dutch is used. In this prospective study three groups of patients are used: 1.Arthroscopic rotator cuff repair; 2.Disorders of the rotator cuff without rupture; 3.Shoulder instability.
The WORC, SF-36 and the Constant Score are obtained twice before therapy is started to measure reliability and validity. Responsiveness is tested by obtaining the same tests after therapy.
|Study Type :||Observational|
|Actual Enrollment :||118 participants|
|Official Title:||Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||March 2014|
Rotator cuff repair group
Patients undergoing an arthroscopic rotator cuff repair
DRC without rupture
Disorders of the rotator cuff without rupture
- Reliability of the WORC [ Time Frame: 6 months ]Reliability of the WORC is tested by comparing the results at T0 with T1. T1 is planned 2-3 weeks after T0, because we expect that the symptoms do not change between these two moments and the time span is large enough to forget initial responses to the questions. In order to signal change in severity of the symptoms, at both moments patients are asked to rate their shoulder hindrance. To determine test-retest reliability, intraclass correlation coefficients (ICC) are used.
- Criterion validity of the WORC [ Time Frame: 6 months ]Criterion validity is measured by comparing WORC with a general quality of life questionnaire (SF-36) and a commonly used clinical shoulder score (Constant Score) both at T0 and T1. Bland Altman plots will be used to estimate 95% boundaries of concurrence.
- Responsiveness of the WORC [ Time Frame: 6 months ]Responsiveness will be determined by calculating the standardized response means and effect sizes on T0 and T2 scores on WORC, SF-36 and Constant scores for the subgroups.
- Differentiation between patient groups [ Time Frame: 6 months ]A comparison of WORC scores between the three distinct groups is made, to see whether WORC scores can differentiate between them. WORC scores will be compared with SF-36 to investigate whether the noted differences correlate with notable clinical differences and can be expressed as MCID's (minimal clinical important differences).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532492
|Department of Orthopedics, St. Antonius Hospital|
|Nieuwegein, Netherlands, 3430 EM|
|Principal Investigator:||Ronald N Wessel, MD||St. Antonius Hospital|
|Principal Investigator:||Henk van Mameren, PhD, MD||Department of Epidemiology, Caphri research school, Maastricht University|
|Principal Investigator:||Rob A de Bie, PhD, MA, RPt||Department of Epidemiology, Caphri research school, Maastricht University|