Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT06505135
Eligibility Criteria:
Inclusion Criteria
* Clinical signs and symptoms compatible with a traumatic RCT
* MR verified supraspinatus tear
* Reparable lesion with tendon retraction \< 2 cm.
* Fatty infiltration level 0-2 (out of 5) according to Fuchs et al. and based on Goutalliers classification
* No history of inflammatory disease
* ASA score \< 3 (patients in good health)
* Signed consent to the study (including use of relevant data from the patient's electronic health records)
Exclusion Criteria
* No MRI of the shoulder
* Former surgery in the affected shoulder
* Signs of infection
* Immunosuppression (due to clinical condition or medical therapy)
* History of inflammatory disease
* Malignancy within 5 years
* Previous radiotherapy to the shoulder
* BMI under 18
* BMI above 35
* Coagulopathy
* Non-Danish speaking patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
69 Years
Study:
NCT06505135
Study Brief:
Protocol Section:
NCT06505135