Active — Not RecruitingNot Applicable

JuggerKnot With Broadband PMCF Study

United States30 participantsStarted 2023-11-30

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Infection where implantation of the device would be compromised;
✕. Conditions including blood supply limitations and insufficient quantity or quality of bone or soft tissue;
✕. Known allergy to one of the JuggerKnot with BroadBand components;
✕. 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.

What they're measuring

Clinical Success

Timeframe: 6 months

Trial details

NCT IDNCT05762588

SponsorRiverpoint Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Shoulder Injuries trials