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.|
|ClinicalTrials.gov Identifier: NCT03935880|
Recruitment Status : Suspended (due to COVID-19)
First Posted : May 2, 2019
Last Update Posted : April 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hallux Rigidus||Device: Cartiva Implant Procedure: Cheilectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Cartiva Hemiarthroplasty
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
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.
- 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).
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03935880
|United States, Wisconsin|
|Madison, Wisconsin, United States, 53715|
|Principal Investigator:||Kurt M Rongstad, MD||University of Wisconsin School of Medicine and Public Health, Madison|