JuggerKnot With Broadband PMCF Study

Not yet recruiting

• Conditions: Hip Injuries; Foot Injury; Ankle Injuries; Knee Injuries; Shoulder Injuries
• Interventions: Device: Juggerknot with Broadband tape

• Registration Number: NCT05762588
• Lead Sponsor: Riverpoint Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-08
• Last Update Submitted: 2023-03-08
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09
• Study Start: 2023-03-31
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients requiring soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip	Juggerknot with Broadband tape	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
VAS Pain Score	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.
PROMIS Physical Function Score	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".
Change in degrees of Range of Motion (ROM) measured by Goniometer	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.
Technical and Procedural Success	Intraoperatively	Successful bone to soft tissue fixation without complications such as anchor pull-out, suture breakage or suture pull through.