Shoulder InjuriesNCT05762588
JuggerKnot With Broadband PMCF Study
An observational study of Shoulder Injuries and Hip Injuries, run by Riverpoint Medical at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Injuries, Hip Injuries, Foot Injury
- What is being tested?
- Juggerknot with Broadband tape
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2023to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 30 participants at approximately 3 clinical sites in the United Sates are planned to be enrolled.
Who may be able to join
- Undergoing soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip where the JuggerKnot with BroadBand anchor is indicated;
- Male or non-pregnant female ≥ 18 years of age;
- Willing to provide informed consent and comply with the required follow-up period.
Who cannot join
- Infection where implantation of the device would be compromised;
- Conditions including blood supply limitations and insufficient quantity or quality of bone or soft tissue;
- Known allergy to one of the JuggerKnot with BroadBand components;
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Health Research Institute
Hyattsville, Maryland, 20782
About this study
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.
- Conditions
- Shoulder Injuries, Hip Injuries, Foot Injury, Ankle Injuries, Knee Injuries
- Being tested
- Juggerknot with Broadband tape
- Keywords
- Soft tissue fixation
- Medical subject headings
- Shoulder Injuries, Hip Injuries, Foot Injuries, Ankle Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juggerknot with Broadband tapeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip | Not described Receives: Device: Juggerknot with Broadband tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Defined as freedom from reintervention due to JuggerKnot with BroadBand failure. Absence of device migration loosening or pull-out.
Measured: 6 months
Secondary outcomes (4)
Technical and Procedural Success
Successful bone to soft tissue fixation without complications such as anchor pull-out, suture breakage or suture pull through.
Measured: Intraoperatively
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".
Measured: 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.
Measured: 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.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start30 Nov 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riverpoint Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762588
- Sponsor's protocol ID
- JUGGPMCF
- Status last verified
- Aug 2025
- First submitted
- 27 Feb 2023
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JuggerKnot With BroadBand Tape Post Market Clinical Follow-Up Study
- ClinicalTrials.gov ID
- NCT05762588
- Acronym / sponsor ID
- JUGGPMCF
- Conditions
- Shoulder Injuries, Hip Injuries, Foot Injury, Ankle Injuries, Knee Injuries
- Keywords
- Soft tissue fixation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riverpoint MedicalIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip | – | Device: Juggerknot with Broadband tape |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 30 participants at approximately 3 clinical sites in the United Sates are planned to be enrolled.
Key inclusion criteria (3 listed)
- Undergoing soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip where the JuggerKnot with BroadBand anchor is indicated;
- Male or non-pregnant female ≥ 18 years of age;
- Willing to provide informed consent and comply with the required follow-up period.
Key exclusion criteria (4 listed)
- Infection where implantation of the device would be compromised;
- Conditions including blood supply limitations and insufficient quantity or quality of bone or soft tissue;
- Known allergy to one of the JuggerKnot with BroadBand components;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juggerknot with Broadband tapeThe 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. | Device | Patients requiring soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip |
Primary outcome
Clinical Success
Time frame: 6 months
Defined as freedom from reintervention due to JuggerKnot with BroadBand failure. Absence of device migration loosening or pull-out.
4 secondary outcomes
Technical and Procedural Success
Time frame: Intraoperatively
PROMIS Physical Function Score
Time frame: Change from baseline to 6 months
VAS Pain Score
Time frame: Change from baseline to 6 months
Change in degrees of Range of Motion (ROM) measured by Goniometer
Time frame: Change from baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Injuries and Hip Injuries, run by Riverpoint Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.