Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair

Disorder of Rotator Cuff Clinical Trial

— WORC  

Official title:

Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532492
• Other study ID #: LTME/Z-11.19/WORC
• 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

Related Conditions & MeSH terms

• Disorder of Rotator Cuff
• Other Instability, Shoulder
• Rotator Cuff Lesion

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