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. Identifier: NCT01532492
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : May 1, 2014
Information provided by (Responsible Party):
Ronald Wessel, St. Antonius Hospital

Brief Summary:

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

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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
Shoulder instability
Shoulder instability

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients undergoing arthroscopic rotator cuff repair. These patients have a clinical suspicion of a symptomatic rotator cuff tear and a partial or full thickness lesion seen on MRI or Ultrasound and confirmed during the arthroscopic repair procedure.
  2. Patients diagnosed as having non-Ruptured DRC. They have a clinical suspicion of DRC and no rupture of the rotator cuff on MRI or Ultrasound.
  3. Patients will be diagnosed with shoulder instability

Inclusion Criteria:

  • 18 years or older
  • written informed consent
  • diagnosis for group 1, 2 or 3

Exclusion Criteria:

  • lack of understanding the Dutch language
  • not able to complete questionnaires independently
  • additional shoulder pathology like adhesive capsulitis, AC-pathology and osteoarthritis
  • previous shoulder surgery

Information from the National Library of Medicine

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 identifier (NCT number): NCT01532492

Department of Orthopedics, St. Antonius Hospital
Nieuwegein, Netherlands, 3430 EM
Sponsors and Collaborators
St. Antonius Hospital
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ronald Wessel, Principal investigator, St. Antonius Hospital Identifier: NCT01532492     History of Changes
Other Study ID Numbers: LTME/Z-11.19/WORC
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by Ronald Wessel, St. Antonius Hospital:
Rotator cuff