Patients Decision-making in Rotator Cuff Surgery

June 29, 2017 updated by: Carlos Torrens, Hospital del Mar

Do we Really Allow Patient Decision-making in Rotator Cuff Surgery? A Prospective Randomized Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with diagnosis of rotator cuff tears documented by MRI

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group A (benefit-inform)
filling questionnaire based on benefits of surgery
Other: questionnaire
fulfillment of questionnaire
group B (side effect-inform)
filling questionnaire based on side-effects of surgery
Other: questionnaire
fulfillment of questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
questionnaire of surgery decision
Time Frame: immediate
two proposals for surgery based on information given to the patient
immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant Score
Time Frame: immediate
functional evaluation of shoulder function
immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2014

Primary Completion (Actual)

September 5, 2014

Study Completion (Actual)

December 29, 2014

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2014/5625/I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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