Surgical Safety and Effectiveness in Orthopedics: Swiss-wide Multicenter Evaluation and Prediction of Core Outcomes in Arthroscopic Rotator Cuff Reconstruction (ARCR_Pred)

University Hospital Basel

Status: Completed

Conditions: Rotator Cuff Tear

Treatments: Procedure: arthroscopic rotator cuff reconstruction

Study type: Observational

Funder types: Other

Identifiers

NCT04321005

2019-02076 ch20Mueller;

Details and patient eligibility

About

Surgical safety and effectiveness in orthopedics: Swiss-wide multicenter evaluation and prediction of core outcomes in arthroscopic rotator cuff reconstruction.

Full description

In this project prospective data are collected from a representative group of specialized clinics performing arthroscopic rotator cuff repair (ARCR) to serve as reference baseline and outcome values, as well as the development of prediction models for individual patients.

Ultrasound and MRI (on a subset of patients) examination will be performed at 12 months.

Enrollment: 973 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients
• diagnosed with a partial or full-thickness rotator cuff tear using magnetic resonance imaging (MRI)
• planned primarily surgical partial or complete repair by arthroscopic procedure
• able to understand the content of the patient information/ consent form and give consent to take part in the project

Exclusion criteria

• surgical procedure for irreparable tears, i.e. muscle transfer, acromio-humeral spacer or superior capsular reconstruction
• revision surgery (prior repair of the rotator cuff in the same shoulder)
• planned open or mini-open reconstructions
• patients with a language barrier hindering questionnaire completion (either in German, French, Italian or English)
• patients unlikely to attend clinical follow-up
• pregnancy
• legal incompetence