Rotator Cuff LesionWORCNCT01532492
Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair
An observational study of Rotator Cuff Lesion and Disorder of Rotator Cuff, run by St. Antonius Hospital at 1 site in Netherlands.
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'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Lesion, Disorder of Rotator Cuff, Other Instability, Shoulder
- How many people
- 118 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2011to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 18 years or older
- written informed consent
- diagnosis for group 1, 2 or 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Orthopedics, St. Antonius Hospital
Nieuwegein, 3430 EM
About this study
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.
Read the 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.
- Keywords
- Questionnaire, WORC, Rotator cuff, Reliability, Validity, Responsiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Wessel, St. Antonius Hospital
- Investigators
- Ronald N Wessel, MD, Principal investigator, St. Antonius HospitalHenk van Mameren, PhD, MD, Principal investigator, Department of Epidemiology, Caphri research school, Maastricht UniversityRob A de Bie, PhD, MA, RPt, Principal investigator, Department of Epidemiology, Caphri research school, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532492
- Sponsor's protocol ID
- LTME/Z-11.19/WORC
- Acronym
- WORC
- Status last verified
- Apr 2014
- First submitted
- 9 Feb 2012
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24359231
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Western Ontario Rotator Cuff Index in Patients With Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT01532492
- Acronym / sponsor ID
- WORC / LTME/Z-11.19/WORC
- Keywords
- Questionnaire, WORC, Rotator cuff, Reliability, Validity, Responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 18 years or older
- written informed consent
- diagnosis for group 1, 2 or 3
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Criterion validity of the WORC
Time frame: 6 months
Responsiveness of the WORC
Time frame: 6 months
Differentiation between patient groups
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
- Derived from this study: PubMed 24359231Wessel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald N Wessel, MD principal investigator
St. Antonius Hospital
Henk van Mameren, PhD, MD principal investigator
Department of Epidemiology, Caphri research school, Maastricht University
Rob A de Bie, PhD, MA, RPt principal investigator
Department of Epidemiology, Caphri research school, Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Lesion and Disorder of Rotator Cuff, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the WORC (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01532492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.