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NCT03935880 · ClinicalTrials.gov registry record · NA
Surgical Treatment for Great Toe Arthritis
A NA study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03935880 is a NA study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 20 participants.
The verdict
NCT03935880, a NA study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
After potential subjects determine that they would like surgical treatment of their great toe arthritis, study staff will approach them about the study. If subject decides to participate, they will be asked to fill out an informed consent. After the informed consent has been signed, study staff will collect subject demographics and medical/surgical history. The subject will be randomized into one of two surgical treatment options: cheilectomy or Cartiva hemiarthroplasty. The randomization ratio will be 1:1 and to ensure this randomization ratio, each randomization block will have 4-6 patients. After the surgery, the subject will have follow up visits at 2 weeks, 6 weeks, 3 months, 1 year, and 2 years post surgery. At these follow up visits, subjects will have a physical exam conducted, have their medical imaging reviewed, and fill out a data collection form which will include questionnaires and adverse event forms (when applicable). All of the above will apply to the 2 week visit, except for the administration of questionnaires/surveys. Additionally, subjects will have incision check, suture removal, and a physical completed during this visit.All study procedures for this study are considered standard of care. Patients would have these completed regardless of participation in the study.
Interventions
- DEVICE Cartiva Implant
- PROCEDURE Cheilectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2021-09-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03935880
The ClinicalTrials.gov registry entry for NCT03935880 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cartiva Implant is the first listed.
NCT03935880 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03935880 about?
NCT03935880 is a clinical study titled "Surgical Treatment for Great Toe Arthritis". After potential subjects determine that they would like surgical treatment of their great toe arthritis, study staff will approach them about the study. If subject decides to participate, they will be asked to fill out an informed consent. After the informed consent has been signed, study staff will...
What is the current status of trial NCT03935880?
This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2019-04-15. Estimated completion is 2021-09-27.
What interventions are being tested in trial NCT03935880?
The interventions under investigation include: Cartiva Implant (DEVICE), Cheilectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03935880?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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