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BETERC: Brazilian epidemiological trial evaluation rotator cuff

Brazilian cohort of patients undergoing rotator cuff repair - BETERC prognostic factors associated to functional disability after rotator cuff repair

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-7j4cc2k
Enrollment
Unknown
Registered
2022-09-19
Start date
2022-10-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator cuff syndrome

Interventions

N05.715.360
N05.715.360.575.575
Rotator cuff injury repair performed arthroscopically and openly in 1,419 individuals with indication for surgical treatment who will be prospectively followed up at periodic return visits of 15, 45 a
E04.555.113
N05.715

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients of both male and female; aged over 18 years; who have a rotator cuff injury with indication for surgical repair confirmed by the exam ultrasound or magnetic resonance imaging; with a record of consent to participate in the study by signing the free and informed consent form.

Exclusion criteria

Exclusion criteria: Patients who refuse to register their consent by signing the term of informed consent; with incomplete documentation; who do not have an magnetic resonance images (MRI) preoperative magnetic field capable of confirming their injuries and those who lose the postoperative follow-up. Those with a history of fracture in the shoulder girdle; previous shoulder surgeries; local neoplasia or undergoing surgical treatment for re-rupture of the rotator cuff will not be included.

Design outcomes

Primary

MeasureTime frame
To assess the impact of the variable "smoking" using a questionnaire, on functional outcome using the WORC score at the end of 1 and 2 years of follow-up. ;To assess the impact of the variable "sex" using a questionnaire, on functional outcome using the WORC score at the end of 1 and 2 years of follow-up.;To assess the impact of the variable "dominance" using a questionnaire, on functional outcome using the WORC score at the end of 1 and 2 years of follow-up.;To assess the impact of the variable "age" using a questionnaire, on functional outcome using the WORC score at the end of 1 and 2 years of follow-up.;To assess the impact of the variable "body mass index" using a questionnaire, on functional outcome using the WORC score at the end of 1 and 2 years of follow-up. ;To assess the impact of the variable "size of the rotator cuff tear" using a millimeter ruler, on functional outcome using the WORC score at the end of 1 and 2 years of follow-up. ;To assess the impact of the variable "fatty infiltration of the muscle" using the Goutallier classification, on functional outcome using the WORC score at the end of 1 and 2 years of follow-up. ;To assess the impact of the variable "anxiety" using the questionnaire PHQ-9, on functional outcome using the WORC score at the end of 1 and 2 years of follow-up. ;To assess the impact of the variable "depression" using the questionnaire GAD-7, on functional outcome using the WORC score at the end of 1 and 2 years of follow-up.

Secondary

MeasureTime frame
Satisfaction assessment will be done using a three degree Likert scale in dissatisfied / partially to satisfied / satisfied;Assess functional performance using the Constant score at the end of 1 and 2 years of follow-up ;To assess prognostic factors related to greater pain perception using the analogue pain scale (EAD) at the end of 15 days, 45 days, 180 days, 1 year and 2 years of follow-up.

Countries

Brazil

Contacts

Public ContactAndré Godinho

Universidade Federal de São Paulo

andre_cgod@hotmail.com+553132891208

Outcome results

None listed

Source: REBEC (via WHO ICTRP)