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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients requiring soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | Defined as freedom from reintervention due to JuggerKnot with BroadBand failure. Absence of device migration loosening or pull-out. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical and Procedural Success | Successful bone to soft tissue fixation without complications such as anchor pull-out, suture breakage or suture pull through. | Intraoperatively |
| PROMIS Physical Function Score |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 30 participants at approximately 3 clinical sites in the United Sates are planned to be enrolled.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Health Research Institute | Hyattsville | Maryland | 20782 | United States |
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| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
| D025981 | Hip Injuries |
| D018409 | Foot Injuries |
| D016512 | Ankle Injuries |
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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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 |
| 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 |
| 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 |