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

NCT01532492 | Completed

• 1 other identifier: LTME/Z-11.19/WORC
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Questionnaire; WORC; Rotator cuff; Reliability; Validity; Responsiveness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Criterion validity of the WORC

  6 months

• Responsiveness of the WORC

  6 months

• Differentiation between patient groups

  6 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• years or older
• written informed consent
• diagnosis for group 1, 2 or 3

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

Department of Orthopedics, St. Antonius Hospital

Nieuwegein, 3430 EM, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 24359231 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 14, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

NL (1)