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Active, Not Recruiting

NCT Number: NCT05762588

JuggerKnot With Broadband PMCF 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Shoulder Injuries Ankle Injuries Foot Injuries Foot Injury Hip Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Clinical Success

    Time frame: 6 months

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

Secondary outcomes

  1. Technical and Procedural Success

    Time frame: Intraoperatively

    Successful bone to soft tissue fixation without complications such as anchor pull-out, suture breakage or suture pull through.

  2. PROMIS Physical Function Score

    Time frame: Change from baseline to 6 months

    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".

  3. VAS Pain Score

    Time frame: Change from baseline to 6 months

    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.

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

    Time frame: Change from baseline to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Riverpoint Medical

Industry

Registry information

Official study title

JuggerKnot With BroadBand Tape Post Market Clinical Follow-Up Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2023
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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