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Completed

NCT Number: NCT01532492

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopedics, St. Antonius Hospital

Nieuwegein, 3430 EM, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Reliability of the WORC

    Time frame: 6 months

    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.

Secondary outcomes

  1. Criterion validity of the WORC

    Time frame: 6 months

    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.

  2. Responsiveness of the WORC

    Time frame: 6 months

    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.

  3. Differentiation between patient groups

    Time frame: 6 months

    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).

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Acronym: WORC

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 14, 2012
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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