Surgical Treatment for Great Toe Arthritis

Stopped early · Not applicable

Conditions studied: Hallux Rigidus

In brief

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.

Key facts

Study ID

NCT03935880

Run by

University of Wisconsin, Madison

People needed

20

Starts

2019-04-15

Expected to finish

2021-09-27

Last updated by the study team

2022-10-28

Who can join

Age: 18 and older, up to 88. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with grade 2 hallux rigidus using the grading system described by Coughlin and Shurnas.8
• Patients older than 18 and less than 88 years of age
• Patients will have the ability to perform the questionnaires and will complete the informed consent process.

You may not qualify if…

• Patients with the diagnosis of gout or inflammatory arthropathy
• Patients with inadequate bone stock of the 1st MTP joint (large bone cyst >1 cm, avascular necrosis)
• Allergy to polyvinyl alcohol
• Anyone unable to commit to follow up appointments
• Patients with significant medical comorbidities that make them unsuitable for elective surgery.

Where it is running

• UW Health — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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