Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01532492
Other study ID # LTME/Z-11.19/WORC
Secondary ID
Status Completed
Phase N/A
First received February 9, 2012
Last updated April 30, 2014
Start date November 2011
Est. completion date March 2014

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Netherlands Department of Orthopedics, St. Antonius Hospital Nieuwegein

Sponsors (1)

Lead Sponsor Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT01885377 - SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain N/A
Withdrawn NCT01538459 - Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block Phase 3
Completed NCT01730573 - Interscalene and Combined Supra Scapular and Axillary Nerve Blocks in Rotator Cuff Repair N/A
Completed NCT01987973 - Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone N/A