Surgical Treatment for Great Toe Arthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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Hallux Rigidus is a common disorder that affects an estimated 1 in 40 people over the age of 50.4 While debate remains about the primary cause of this disorder, it is likely multifactorial with contributing factors including previous trauma, malalignment and underlying genetic influences.5 Regardless of the cause, the disorder can become progressive and significantly impact a patient's quality of life. Common symptoms include pain, swelling and limited range of motion. Patients often present with pain dorsally over the first metatarsophalangeal (MTP) joint secondary to osteophyte formation and swelling. This can restrict range of motion at this joint, as well as make daily activities, such as wearing closed-toed shoes, quite difficult.6 Furthermore, continued pain can lead to gait abnormalities with more weight bearing through the lateral aspect of the foot and potential transfer metatarsalgia.7 Along with physical exam to identify first MTP range of motion, joint swelling, erythema and palpable osteophyte formation, radiographic evaluation is part of the standard of care in hallux rigidus evaluation. Coughlin and Shurnas proposed a grading system that has become widely used, based on the radiographic findings and range of motion at the MTP joint.8 The grading system allowed clinicians to characterize patients from grade 0-4, helping guide treatment decisions. Initial treatment is centered on pain relief with non-operative modalities. Modified shoe wear, custom orthotics with a Morton extension and activity modifications have all been shown to improve symptoms in some patients.7 For patients that fail non-operative therapies, a wide array of surgical options exist. For patients with Grade 1 and 2 hallux rigidus, joint sparing procedures have been primarily used, with the most common procedure being Cheilectomy. The Cheilectomy procedure involves removal of the dorsal osteophytes and 20-30% of the dorsal metatarsal head.3 The benefits of this procedure include the ability to improve joint mobility, while still leaving the potential for future fusion. Success rates have been reported between 72% and 100% in patients with grade 1 and 2 hallux rigidus.7 Controversy remains regarding cheilectomy in patients with grade 3 hallux rigidus however. Nicolosi et al found an average satisfaction rate of 85% in patients with grade 3 disease undergoing cheilectomy3. Additional studies, however have suggested high failure and revision rates in patients with grade 3 hallux rigidus.3 Joint fusion has become common place in the treatment of advanced stage hallux rigidus, including grade 3 and 4. High fusion rates and patient satisfaction has been proven with fusion procedures in the first MTP joint.7 However, the loss of motion at the first MTP joint associated with the fusion procedure can interfere with activities such as running and jumping, and can make shoe wear choices difficult2. These limitations led to the push for development of a joint replacement procedure, allowing for pain control and continued motion. The use of silicone-based joint replacement has been met with mixed results, however concerns over the durability leading to implant fracture, osteolysis and difficulty of revision procedures has ultimately limited its use.9 Ceramic implants were found to have good short-term results, however concerns remain regarding the large amount of subsidence seen in follow up, as well as potential osteolysis10. Furthermore, the amount of bone stock remaining following this procedure could make revision procedures quite challenging. Given these mixed results, there remained a significant drive to identify a joint replacement-type procedure with a device that could maintain adequate bone stock, preserve motion and withstand the daily stresses the first MTP joint faces. This led to the use of the Cartiva implant, a polyvinyl alcohol hydrogel implant. Following extensive safety and wear testing, it was determined that this implant would be well suited for use in patients with hallux rigidus. Indicated for grade 2, 3 and 4 hallux rigidus, the initial study of Cartiva effectiveness compared outcomes of the implant versus arthrodesis. The prospective, randomized control trial evaluated 202 patients, with over 2/3 undergoing the Cartiva procedure.2 Both short and midterm outcomes were very promising. 5-year revision rates were found to be 5% with no evidence of implant loosening or surrounding bone complication.11 Additionally, the Cartiva implant was found to be equivalent to the gold standard, arthrodesis, when it came to post-operative patient outcome scores, range of motion and complications.2 With promising results from initial clinical trials, further evaluation into the efficacy and indications for Cartiva is necessary. To date, there is no published literature comparing Cheilectomy to Cartiva. Both procedures have shown to have beneficial results in patients with grade 2 hallux rigidus, yet it is unclear if one procedure would be preferred in this population or certain subsets of patients. With an estimated revision rate around 9% following Cheilectomy, it is possible that Cartiva could decrease the need for additional procedures.

Official Title
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Treatment of Hallux Rigidus With Synthetic Hemiarthroplasty Versus Cheilectomy: A Randomized Controlled Trial

Conditions
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Hallux Rigidus

Intervention / Treatment
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* Device: Cartiva Implant
* Procedure: Cheilectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cartiva Hemiarthroplasty<br>Cartiva implant | Device: Cartiva Implant<br>* 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.<br>|
| Active Comparator: Cheilectomy<br>Bone spur removal | Procedure: Cheilectomy<br>* 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 sagittal saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-ADL) Questionnaire | The Foot and Ankle Ability Measure (FAAM-ADL) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The 21-item FAAM-ADL Questionnaire: scored as N/A, unable to do, extreme difficulty, moderate difficulty, slight difficulty, no difficulty, and/or a percentage (scale from 0-100, where higher scores indicate better physical function). | pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2 | 
| Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-Sports) Questionnaire | The Foot and Ankle Ability Measure (FAAM-Sports) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. FAAM-Sports Questionnaire is an 8-item survey: scored as N/A, unable to do, extreme difficulty, moderate difficulty, slight difficulty, no difficulty, and/or a percentage (scale from 0-100, where higher scores indicate higher level of physical function). | pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2 | 
| Change in Patient Health: Assessment by Short Form-36 Physical Component Scores (SF-36 PCS) Questionnaire | 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 | pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2 | 
| Change in Patient Health: Assessment by Short Form-36 Mental Component Scores (SF-36 MCS) Questionnaire | 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 | pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in First MTP Peak Active Dorsiflexion | This is a measure of the amount of dorsiflexion of the first metatarsophalangeal joint. It is performed by the clinician and measured with a protractor in clinic. It was measured preoperatively and post operatively. | pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2 | 
| Change Visual Analog Scale (VAS) for Pain | The VAS for pain is measured on a 0 to 100 point scale where 0 represents no pain and 100 indicates pain as bad as it could possibly be. | pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2 |