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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald Wessel, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01532492
First received: February 9, 2012
Last updated: April 30, 2014
Last verified: April 2014

February 9, 2012
April 30, 2014
November 2011
December 2013   (final data collection date for primary outcome measure)
Reliability of the WORC [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01532492 on ClinicalTrials.gov Archive Site
  • Criterion validity of the WORC [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.
  • Responsiveness of the WORC [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.
  • Differentiation between patient groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).
Same as current
Not Provided
Not Provided
 
Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair
Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
  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
  • Rotator Cuff Lesion
  • Disorder of Rotator Cuff
  • Other Instability, Shoulder
Not Provided
  • 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
Wessel RN, Wolterbeek N, Fermont AJ, van Mameren H, Sonneveld H, Griffin S, de Bie RA. The conceptually equivalent Dutch version of the Western Ontario Rotator Cuff Index (WORC)©. BMC Musculoskelet Disord. 2013 Dec 21;14:362. doi: 10.1186/1471-2474-14-362.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
March 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01532492
LTME/Z-11.19/WORC
No
Ronald Wessel, St. Antonius Hospital
St. Antonius Hospital
Not Provided
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
St. Antonius Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP