Clinical trial NCT01532492: Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair
Official title: Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Lesion
Disorder of Rotator Cuff
Other Instability, Shoulder
Keywords: Questionnaire
WORC
Rotator cuff
Reliability
Validity
Responsiveness
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reliability of the WORC
timeFrame: 6 months
Secondary outcomes:
measure: Criterion validity of the WORC
timeFrame: 6 months
measure: Responsiveness of the WORC
timeFrame: 6 months
measure: Differentiation between patient groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: Department of Orthopedics, St. Antonius Hospital
Study officials:
affiliation: St. Antonius Hospital
name: Ronald N Wessel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Epidemiology, Caphri research school, Maastricht University
name: Henk van Mameren, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Epidemiology, Caphri research school, Maastricht University
name: Rob A de Bie, PhD, MA, RPt
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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)(c). BMC Musculoskelet Disord. 2013 Dec 21;14:362. doi: 10.1186/1471-2474-14-362.