PMCF Study on PEEK Suture Anchors for Shoulder Indications

Smith & Nephew

Status: Completed

Conditions: Soft Tissue to Bone Fixation

Treatments: Device: Polyetheretherketone (PEEK) Shoulder Suture Anchors

Study type: Observational

Funder types: Industry

Identifiers

NCT03826667

2018.16.SMD.PEEK.RET.SHD

Details and patient eligibility

About

Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.

Enrollment: 464 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who have undergone shoulder joint repair using the study devices.
2. Subjects aged 18 years and older at the time of surgery.

Exclusion criteria

1. Subjects who are < 12 months post-operative.
2. Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery.

Trial design