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Surgical Treatment for Great Toe Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03935880
Recruitment Status : Suspended (due to COVID-19)
First Posted : May 2, 2019
Last Update Posted : April 7, 2020
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Hallux Rigidus Device: Cartiva Implant Procedure: Cheilectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Hallux Rigidus With Synthetic Hemiarthroplasty Versus Cheilectomy: A Randomized Controlled Trial
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Arm Intervention/treatment
Active Comparator: Cartiva Hemiarthroplasty
Cartiva implant
Device: Cartiva Implant
Cartiva hemiarthroplasty: The procedure starts with a small incision over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the metatarsal and a drill is then used to create a site for the implant. The implant is then placed using the implant introducer. The incision is then closed and a sterile dressing is placed.

Active Comparator: Cheilectomy
Bone spur removal
Procedure: Cheilectomy
Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then cut with a saggital saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.

Primary Outcome Measures :
  1. Change in foot and ankle ability : Assessment by Foot and Ankle Ability Measure (FAAM) Questionnaire [ Time Frame: Week 2, Week 6, Month 3, Year 1, and Year 2 ]
    The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. FAAM Questionnaire: scored as N/A, unable to do, extreme difficulty, moderate difficulty, slight difficulty, no difficulty, and/or a percentage (scale from 0-100).

  2. Change in patient health : Assessment by 36-Item Short Form Survey (SF-36) Questionnaire [ Time Frame: Week 2, Week 6, Month 3, Year 1, and Year 2 ]
    The SF-36 is an indicator of overall health status. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability, higher scores = less disability

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03935880

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United States, Wisconsin
UW Health
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
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Principal Investigator: Kurt M Rongstad, MD University of Wisconsin School of Medicine and Public Health, Madison

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Responsible Party: University of Wisconsin, Madison Identifier: NCT03935880    
Other Study ID Numbers: 2018-1546
A536110 ( Other Identifier: UW Madison )
SMPH/ORTHO&REHAB/ORTHO ( Other Identifier: UW Madison )
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hallux Rigidus
Hallux Limitus
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Joint Diseases
Foot Injuries
Leg Injuries
Wounds and Injuries