Knee Injuries Clinical Trial
Official title:
JuggerKnot With BroadBand Tape Post Market Clinical Follow-Up Study
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Riverpoint Medical | Global CRO |
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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