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JuggerKnot With Broadband PMCF Study

R

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

Trial contacts and locations

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Central trial contact

Edwin Anderson; Marysa Mezzetti

Data sourced from clinicaltrials.gov

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