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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05762588
Other study ID # JUGGPMCF
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 31, 2023
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source Riverpoint Medical
Contact Marysa Mezzetti
Phone 617-435-3840
Email marysa.mezzetti@rpmed.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 31, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Riverpoint Medical Global CRO

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Success Defined as freedom from reintervention due to JuggerKnot with BroadBand failure. Absence of device migration loosening or pull-out. 6 months
Secondary Technical and Procedural Success Successful bone to soft tissue fixation without complications such as anchor pull-out, suture breakage or suture pull through. Intraoperatively
Secondary 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
Secondary 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
Secondary 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
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