- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532492
Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair (WORC)
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.
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nieuwegein, Netherlands, 3430 EM
- Department of Orthopedics, St. Antonius Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- 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.
- 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.
- Patients will be diagnosed with shoulder instability
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Rotator cuff repair group
Patients undergoing an arthroscopic rotator cuff repair
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DRC without rupture
Disorders of the rotator cuff without rupture
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Shoulder instability
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Reliability of the WORC
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Criterion validity of the WORC
Time Frame: 6 months
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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.
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6 months
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Responsiveness of the WORC
Time Frame: 6 months
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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.
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6 months
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Differentiation between patient groups
Time Frame: 6 months
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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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6 months
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Collaborators and Investigators
Sponsor
Investigators
- 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 and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LTME/Z-11.19/WORC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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