Patients Decision-making in Rotator Cuff Surgery

Rotator Cuff Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205852
• Other study ID #: 2014/5625/I
• Status: Completed
• Phase: N/A
• First received: June 29, 2017
• Last updated: June 29, 2017
• Start date: July 7, 2014
• Est. completion date: December 29, 2014

Study information

• Verified date: June 2017
• Source: Hospital del Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 29, 2014
• Est. primary completion date: September 5, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Disease

Intervention

Other:
• questionnaire
fulfillment of questionnaire

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Mar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	questionnaire of surgery decision	two proposals for surgery based on information given to the patient	immediate
Secondary	Constant Score	functional evaluation of shoulder function	immediate