JuggerKnot With Broadband PMCF Study

N/AActive Not RecruitingNCT05762588

Riverpoint Medical30 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Shoulder Injuries Hip Injuries Foot Injury Ankle Injuries Knee Injuries

Interventions

Juggerknot with Broadband tapeDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

MedStar Health Research Institute

Hyattsville, Maryland, United States

Outcomes

Primary Outcomes

Clinical Success

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

Time frame: 6 months

Secondary Outcomes

Technical and Procedural Success

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

Time frame: 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".

Time frame: 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.

Time frame: 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.

Time frame: Change from baseline to 6 months

Data from ClinicalTrials.gov

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