JuggerKnot With Broadband PMCF Study

Knee Injuries Clinical Trial

Official title:

JuggerKnot With BroadBand Tape Post Market Clinical Follow-Up Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05762588
• Other study ID #: JUGGPMCF
• Status: Not yet recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

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

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