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:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01849458
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years of age or older
* Patients with full thickness rotator cuff tears (confirmed at time of surgery) that are eligible for rotator cuff repair.
* Patients willing and able to comply with the requirements of the study protocol and provide informed consent.
Exclusion Criteria:
* Patients with active or latent infection
* Patients with decreased vascularity
* Patients with pathological soft tissue conditions
* Patients with a known allergy or sensitivity to tetracycline hydrochloride or kanamycin sulfate
* Patients with a known allergy or sensitivity to bovine collagen (BioFiber-CM only)
* Participating in a concurrent study that has not been approved for concurrent enrollment by the Clinical Study Manager
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01849458
Study Brief:
Protocol Section:
NCT01849458