Surgical Treatment for Great Toe Arthritis

NCT03935880 | Terminated Results FDA Device

• 3 other identifiers: 2018-1546A536110SMPH/ORTHO&REHAB/ORTHO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Rigidus

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change in First MTP Peak Active Dorsiflexion

  pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2

• Change Visual Analog Scale (VAS) for Pain

  pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2

Study Arms (2)

Cartiva Hemiarthroplasty

ACTIVE COMPARATOR

Cartiva implant

Device: Cartiva Implant

Cheilectomy

ACTIVE COMPARATOR

Bone spur removal

Procedure: Cheilectomy

Interventions

Cartiva Implant DEVICE

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.

Cartiva Hemiarthroplasty

Cheilectomy PROCEDURE

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.

Cheilectomy

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW Health

Madison, Wisconsin, 53715, United States

Location

Related Publications (14)

• 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.

  PMID: 28567339 BACKGROUND

• Baumhauer 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.

  PMID: 26922669 BACKGROUND

• Nicolosi 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.

  PMID: 25981441 BACKGROUND

• Gould 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.

  PMID: 6115797 BACKGROUND

• Lucas 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.

  PMID: 26320553 BACKGROUND

• Kunnasegaran 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.

  PMID: 26320555 BACKGROUND

• Yee 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.

  PMID: 18549766 BACKGROUND

• Coughlin MJ, Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am. 2003 Nov;85(11):2072-88.

  PMID: 14630834 BACKGROUND

• Sullivan MR. Hallux rigidus: MTP implant arthroplasty. Foot Ankle Clin. 2009 Mar;14(1):33-42. doi: 10.1016/j.fcl.2008.11.009.

  PMID: 19232990 BACKGROUND

• Chee 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.

  PMID: 21276558 BACKGROUND

• Daniels 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.

  PMID: 27909032 BACKGROUND

• Heller 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.

  PMID: 28850536 BACKGROUND

• Madeley 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.

  PMID: 22381237 BACKGROUND

• Cullen 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.

  PMID: 28476391 BACKGROUND

MeSH Terms

Conditions

Hallux Rigidus

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Joint Diseases

Limitations and Caveats

This study was terminated early and was not powered for meaningful results per the protocol. Median data at each timepoint are reported here.

Results Point of Contact

• Title: Andrew Brooks
• Organization: University of Wisconsin - Madison

abrooks2@uwhealth.org

248-953-9777

Study Officials

• Kurt M Rongstad, MD

  University of Wisconsin School of Medicine and Public Health, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: April 15, 2019
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: October 28, 2022
• Results First Posted: July 22, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)