Disorder of Rotator Cuff Clinical Trial
— WORCOfficial title:
Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair
Verified date | April 2014 |
Source | St. Antonius Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Medical Ethics Review Committee (METC) |
Study type | Observational |
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.
Status | Completed |
Enrollment | 118 |
Est. completion date | March 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | Department of Orthopedics, St. Antonius Hospital | Nieuwegein |
Lead Sponsor | Collaborator |
---|---|
St. Antonius Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reliability of the WORC | 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. | 6 months | No |
Secondary | Criterion validity of the WORC | 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. | 6 months | No |
Secondary | Responsiveness of the WORC | 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. | 6 months | No |
Secondary | Differentiation between patient groups | 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). | 6 months | No |
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