JuggerKnot With Broadband PMCF Study

NCT ID: NCT05762588

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-30

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Shoulder Injuries Hip Injuries Foot Injury Ankle Injuries Knee Injuries

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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

Juggerknot with Broadband tape

Intervention Type DEVICE

The JuggerKnot system is comprised of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue to bone fixation by bunching against the bone when deployed. The anchor sleeve material is polyester. Suture materials are ultra-high molecular weight polyethylene. The device has 510K FDA clearance.

Interventions

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Juggerknot with Broadband tape

The JuggerKnot system is comprised of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue to bone fixation by bunching against the bone when deployed. The anchor sleeve material is polyester. Suture materials are ultra-high molecular weight polyethylene. The device has 510K FDA clearance.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riverpoint Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MedStar Health Research Institute

Hyattsville, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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JUGGPMCF

Identifier Type: -

Identifier Source: org_study_id

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