JuggerKnot With Broadband PMCF Study

NCT05762588 | Active Not Recruiting FDA Device

• 1 other identifier: JUGGPMCF
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Soft tissue fixation

Outcome Measures

Primary Outcomes (1)

• Clinical Success

  Defined as freedom from reintervention due to JuggerKnot with BroadBand failure. Absence of device migration loosening or pull-out.

  6 months

Secondary Outcomes (4)

• Technical and Procedural Success

  Intraoperatively

• PROMIS Physical Function Score

  Change from baseline to 6 months

• VAS Pain Score

  Change from baseline to 6 months

• Change in degrees of Range of Motion (ROM) measured by Goniometer

  Change from baseline to 6 months

Study Arms (1)

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

Device: Juggerknot with Broadband tape

Interventions

Juggerknot with Broadband tape 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 30 participants at approximately 3 clinical sites in the United Sates are planned to be enrolled.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riverpoint Medical: lead

Study Sites (1)

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

MeSH Terms

Conditions

Shoulder Injuries; Hip Injuries; Foot Injuries; Ankle Injuries; Knee Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: November 30, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)