JuggerKnot With Broadband PMCF Study

Riverpoint Medical

Status: Not yet enrolling

Conditions: Knee Injuries; Hip Injuries; Shoulder Injuries; Foot Injury; Ankle Injuries

Treatments: Device: Juggerknot with Broadband tape

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05762588

JUGGPMCF

Details and patient eligibility

About

The purpose of the study is to collect post-market clinical follow-up data, which is needed to confirm the safety and performance of the JuggerKnot device and meet existing EU regulatory requirements.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Undergoing soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip where the JuggerKnot with BroadBand anchor is indicated;
2. Male or non-pregnant female ≥ 18 years of age;
3. Willing to provide informed consent and comply with the required follow-up period.

Exclusion criteria

1. Infection where implantation of the device would be compromised;
2. Conditions including blood supply limitations and insufficient quantity or quality of bone or soft tissue;
3. Known allergy to one of the JuggerKnot with BroadBand components;
4. Mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions or patients who are otherwise unwilling or incapable of doing so.

Trial design

30 participants in 1 patient group

Patients requiring soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip

Treatment:

Device: Juggerknot with Broadband tape