NCT03205852

Brief Summary

The objective of this study was to evaluate the effect on patient treatment decision-making if information was given based on the benefit or on the side effect in rotator cuff disorders.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

June 29, 2017

Last Update Submit

June 29, 2017

Conditions

Rotator Cuff Disease

Outcome Measures

Primary Outcomes (1)

  • questionnaire of surgery decision

    two proposals for surgery based on information given to the patient

    immediate

Secondary Outcomes (1)

  • Constant Score

    immediate

Study Arms (2)

group A (benefit-inform)

filling questionnaire based on benefits of surgery

Other: questionnaire

group B (side effect-inform)

filling questionnaire based on side-effects of surgery

Other: questionnaire

Interventions

questionnaireOTHER

fulfillment of questionnaire

group A (benefit-inform)group B (side effect-inform)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with diagnosis of rotator cuff tears documented by MRI

You may qualify if:

  • patients diagnosed with rotator cuff tears at their first clinical visit

You may not qualify if:

  • patients with a previous shoulder surgery, patients with worker's compensation and patients who were unwilling to participate and thereby not sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Torrens C, Miquel J, Santana F. Do we really allow patient decision-making in rotator cuff surgery? A prospective randomized study. J Orthop Surg Res. 2019 Apr 29;14(1):116. doi: 10.1186/s13018-019-1157-2.

    PMID: 31036041DERIVED

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Clinic Upper Limb

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 2, 2017

Study Start

July 7, 2014

Primary Completion

September 5, 2014

Study Completion

December 29, 2014

Last Updated

July 2, 2017

Record last verified: 2017-06