JuggerKnot With Broadband PMCF Study

JuggerKnot With BroadBand Tape Post Market Clinical Follow-Up Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Shoulder Injuries; Knee Injuries; Hip Injuries; Ankle Injuries; Foot Injury
• Intervention / Treatment: Device: Juggerknot with Broadband tape

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • MedStar Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients requiring soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success	Defined as freedom from reintervention due to JuggerKnot with BroadBand failure. Absence of device migration loosening or pull-out.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical and Procedural Success	Successful bone to soft tissue fixation without complications such as anchor pull-out, suture breakage or suture pull through.	Intraoperatively
PROMIS Physical Function Score	The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score".	Change from baseline to 6 months
VAS Pain Score	A VAS consists of a line, often 10 cm long, with verbal anchors at either end, similar to an NRS (e.g., "no pain" on the far left and "the most intense pain imaginable" on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.	Change from baseline to 6 months
Change in degrees of Range of Motion (ROM) measured by Goniometer	The extent or limit to which a part of the body can be moved around a joint or a fixed point. ROM will depend on the anatomy being studies. ROM will be measured by goniometer.	Change from baseline to 6 months

Collaborators and Investigators

• Sponsor: Riverpoint Medical
• Collaborators: Global CRO

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Soft tissue fixation
• Additional Relevant MeSH Terms: Leg Injuries; Shoulder Injuries; Ankle Injuries; Wounds and Injuries; Knee Injuries; Hip Injuries; Foot Injuries
• Other Study ID Numbers: JUGGPMCF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes