Hallux RigidusNCT03935880
Surgical Treatment for Great Toe Arthritis
A study testing Cartiva Implant and Cheilectomy in people with Hallux Rigidus, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Hallux Rigidus
- What is being tested?
- Cartiva Implant and Cheilectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 27 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Hallux Rigidus With Synthetic Hemiarthroplasty Versus Cheilectomy: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Hallux Rigidus
- Being tested
- Cartiva Implant, Cheilectomy
- Medical subject headings
- Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartiva ImplantDevice
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.
CheilectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cartiva Hemiarthroplasty | Active comparator | Cartiva implant Receives: Device: Cartiva Implant |
| Cheilectomy | Active comparator | Bone spur removal Receives: Procedure: Cheilectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
Measured: 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
Measured: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2
Secondary outcomes (2)
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.
Measured: 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.
Measured: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start15 Apr 2019
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Why it stopped: difficulty meeting recruitment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Hallux RigidusStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kurt M Rongstad, MD, Principal investigator, University of Wisconsin School of Medicine and Public Health, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935880
- Sponsor's protocol ID
- 2018-1546
- Other IDs
- A536110, SMPH/ORTHO&REHAB/ORTHO
- Status last verified
- Oct 2022
- First submitted
- 30 Apr 2019
- Last updated
- 28 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lam A, Chan JJ, Surace MF, Vulcano E. Hallux rigidus: How do I approach it? World J Orthop. 2017 May 18;8(5):364-371. doi: 10.5312/wjo.v8.i5.364. eCollection 2017 May 18.
PubMed 28567339Baumhauer JF, Singh D, Glazebrook M, Blundell C, De Vries G, Le IL, Nielsen D, Pedersen ME, Sakellariou A, Solan M, Wansbrough G, Younger AS, Daniels T; for and on behalf of the CARTIVA Motion Study Group. Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus. Foot Ankle Int. 2016 May;37(5):457-69. doi: 10.1177/1071100716635560. Epub 2016 Feb 27.
PubMed 26922669Nicolosi N, Hehemann C, Connors J, Boike A. Long-Term Follow-Up of the Cheilectomy for Degenerative Joint Disease of the First Metatarsophalangeal Joint. J Foot Ankle Surg. 2015 Nov-Dec;54(6):1010-20. doi: 10.1053/j.jfas.2014.12.035. Epub 2015 May 14.
PubMed 25981441Gould N, Schneider W, Ashikaga T. Epidemiological survey of foot problems in the continental United States: 1978-1979. Foot Ankle. 1980 Jul;1(1):8-10. doi: 10.1177/107110078000100104.
PubMed 6115797Lucas DE, Hunt KJ. Hallux Rigidus: Relevant Anatomy and Pathophysiology. Foot Ankle Clin. 2015 Sep;20(3):381-9. doi: 10.1016/j.fcl.2015.04.001. Epub 2015 Jul 4.
PubMed 26320553Kunnasegaran R, Thevendran G. Hallux Rigidus: Nonoperative Treatment and Orthotics. Foot Ankle Clin. 2015 Sep;20(3):401-12. doi: 10.1016/j.fcl.2015.04.003. Epub 2015 Jun 9.
PubMed 26320555Yee G, Lau J. Current concepts review: hallux rigidus. Foot Ankle Int. 2008 Jun;29(6):637-46. doi: 10.3113/FAI.2008.0637. No abstract available.
PubMed 18549766Coughlin MJ, Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am. 2003 Nov;85(11):2072-88.
PubMed 14630834Sullivan MR. Hallux rigidus: MTP implant arthroplasty. Foot Ankle Clin. 2009 Mar;14(1):33-42. doi: 10.1016/j.fcl.2008.11.009.
PubMed 19232990Chee YH, Clement N, Ahmed I, Thomson CE, Gibson JN. Functional outcomes following ceramic total joint replacement for hallux rigidus. Foot Ankle Surg. 2011 Mar;17(1):8-12. doi: 10.1016/j.fas.2009.11.005.
PubMed 21276558Daniels TR, Younger AS, Penner MJ, Wing KJ, Miniaci-Coxhead SL, Pinsker E, Glazebrook M. Midterm Outcomes of Polyvinyl Alcohol Hydrogel Hemiarthroplasty of the First Metatarsophalangeal Joint in Advanced Hallux Rigidus. Foot Ankle Int. 2017 Mar;38(3):243-247. doi: 10.1177/1071100716679979. Epub 2016 Dec 7.
PubMed 27909032Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
PubMed 28850536Madeley NJ, Wing KJ, Topliss C, Penner MJ, Glazebrook MA, Younger AS. Responsiveness and validity of the SF-36, Ankle Osteoarthritis Scale, AOFAS Ankle Hindfoot Score, and Foot Function Index in end stage ankle arthritis. Foot Ankle Int. 2012 Jan;33(1):57-63. doi: 10.3113/FAI.2012.0057.
PubMed 22381237Cullen B, Stern AL, Weinraub G. Rate of Revision After Cheilectomy Versus Decompression Osteotomy in Early-Stage Hallux Rigidus. J Foot Ankle Surg. 2017 May-Jun;56(3):586-588. doi: 10.1053/j.jfas.2017.01.038.
PubMed 28476391
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hallux Rigidus With Synthetic Hemiarthroplasty Versus Cheilectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03935880
- Acronym / sponsor ID
- 2018-1546
- Conditions
- Hallux Rigidus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty meeting recruitment goals
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Posted 22 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cartiva Hemiarthroplasty | Active comparator | Device: Cartiva ImplantCartiva implant |
| Cheilectomy | Active comparator | Procedure: CheilectomyBone spur removal |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cartiva ImplantCartiva 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. | Device | Cartiva Hemiarthroplasty |
| CheilectomyCheilectomy: 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. | Procedure or surgery | Cheilectomy |
Primary outcome
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-ADL) Questionnaire
Time frame: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2
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).
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-Sports) Questionnaire
Time frame: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2
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).
Change in Patient Health: Assessment by Short Form-36 Physical Component Scores (SF-36 PCS) Questionnaire
Time frame: pre-operative baseline, post-operative 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
Change in Patient Health: Assessment by Short Form-36 Mental Component Scores (SF-36 MCS) Questionnaire
Time frame: pre-operative baseline, post-operative 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
2 secondary outcomes
Change in First MTP Peak Active Dorsiflexion
Time frame: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2
Change Visual Analog Scale (VAS) for Pain
Time frame: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28567339Lam A, Chan JJ, Surace MF, Vulcano E. Hallux rigidus: How do I approach it? World J Orthop. 2017 May 18;8(5):364-371. doi: 10.5312/wjo.v8.i5.364. eCollection 2017 May 18.
- Background: PubMed 26922669Baumhauer JF, Singh D, Glazebrook M, Blundell C, De Vries G, Le IL, Nielsen D, Pedersen ME, Sakellariou A, Solan M, Wansbrough G, Younger AS, Daniels T; for and on behalf of the CARTIVA Motion Study Group. Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus. Foot Ankle Int. 2016 May;37(5):457-69. doi: 10.1177/1071100716635560. Epub 2016 Feb 27.
- Background: PubMed 25981441Nicolosi N, Hehemann C, Connors J, Boike A. Long-Term Follow-Up of the Cheilectomy for Degenerative Joint Disease of the First Metatarsophalangeal Joint. J Foot Ankle Surg. 2015 Nov-Dec;54(6):1010-20. doi: 10.1053/j.jfas.2014.12.035. Epub 2015 May 14.
- Background: PubMed 6115797Gould N, Schneider W, Ashikaga T. Epidemiological survey of foot problems in the continental United States: 1978-1979. Foot Ankle. 1980 Jul;1(1):8-10. doi: 10.1177/107110078000100104.
- Background: PubMed 26320553Lucas DE, Hunt KJ. Hallux Rigidus: Relevant Anatomy and Pathophysiology. Foot Ankle Clin. 2015 Sep;20(3):381-9. doi: 10.1016/j.fcl.2015.04.001. Epub 2015 Jul 4.
- Background: PubMed 26320555Kunnasegaran R, Thevendran G. Hallux Rigidus: Nonoperative Treatment and Orthotics. Foot Ankle Clin. 2015 Sep;20(3):401-12. doi: 10.1016/j.fcl.2015.04.003. Epub 2015 Jun 9.
- Background: PubMed 18549766Yee G, Lau J. Current concepts review: hallux rigidus. Foot Ankle Int. 2008 Jun;29(6):637-46. doi: 10.3113/FAI.2008.0637. No abstract available.
- Background: PubMed 14630834Coughlin MJ, Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am. 2003 Nov;85(11):2072-88.
- Background: PubMed 19232990Sullivan MR. Hallux rigidus: MTP implant arthroplasty. Foot Ankle Clin. 2009 Mar;14(1):33-42. doi: 10.1016/j.fcl.2008.11.009.
- Background: PubMed 21276558Chee YH, Clement N, Ahmed I, Thomson CE, Gibson JN. Functional outcomes following ceramic total joint replacement for hallux rigidus. Foot Ankle Surg. 2011 Mar;17(1):8-12. doi: 10.1016/j.fas.2009.11.005.
- Background: PubMed 27909032Daniels TR, Younger AS, Penner MJ, Wing KJ, Miniaci-Coxhead SL, Pinsker E, Glazebrook M. Midterm Outcomes of Polyvinyl Alcohol Hydrogel Hemiarthroplasty of the First Metatarsophalangeal Joint in Advanced Hallux Rigidus. Foot Ankle Int. 2017 Mar;38(3):243-247. doi: 10.1177/1071100716679979. Epub 2016 Dec 7.
- Background: PubMed 28850536Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt M Rongstad, MD principal investigator
University of Wisconsin School of Medicine and Public Health, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cartiva Implant and Cheilectomy in people with Hallux Rigidus, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-ADL) Questionnaire (time frame: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935880, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.