One-year Follow-Up Results with Hydrogel Implant in Therapy of Hallux Rigidus: Case Series with 44 Patients

Abstract

Background The Cartiva implant (CI) is being increasingly used in the surgical therapy of hallux rigidus. Despite a growing number of studies, numerous questions regarding patient selection remain unanswered.

Patients and Methods As part of a retrospective case series with prospective follow-up (average follow-up period: 12 months), a total of 44 patients (male/female = 16/28; mean age at the time of surgery: 55.4 years) with 44 CI were analysed (VAS, EFAS-, AOFAS-score). Using a correlation analysis and a machine learning algorithm, risk factors for therapy failure were investigated.

Results The overall survival rate of the CI was 93% at 12 months. The VAS, EFAS and AOFAS scores showed a significant improvement in comparison to the preoperative condition. The mobility of the metatarsophalangeal joint showed no increase. Patients with a medium osteoarthritis grade and a medium level of clinical restraint showed the greatest improvement in relation to their preoperative condition.

Conclusion The CI can be seen as an effective therapy for hallux rigidus. Nonetheless, realistic patient expectations must be communicated.

Key words

Osteoarthritis - EFAS - Polyvinyl Alcohol (PVA) Hydrogel - joint preserving

^* C. Zanzinger and N. Harrasser share first authorship.

^# H. Hörterer and M. Walther share senior authorship.

Publication History

Article published online:
01 March 2021

• References/Literatur

• 1 van Saase JL, van Romunde LK, Cats A. et al. Epidemiology of osteoarthritis: Zoetermeer survey. Comparison of radiological osteoarthritis in a Dutch population with that in 10 other populations. Ann Rheum Dis 1989; 48: 271-280
• 2 Wasserstein RL. The ASAʼs Statement on p-Values: Context, Process, and Purpose. Am Stat 2016; 70: 129-133
• 3 Patel J, Swords M. Hallux Rigidus. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2020. Im Internet (Stand: 01.02.2021): https://www.ncbi.nlm.nih.gov/books/NBK556019/
• 4 Coughlin MJ, Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am 2003; 85: 2072-2088
• 5 Fuhrmann R. Hallux rigidus: Arthrodese vs. Endoprothese. Trauma und Berufskrankheit 2010; 12: 119-124
• 6 Hengstmann K, Klapper U. Hallux rigidus. OUP 2016; 12: 674-678
• 7 Ho B, Baumhauer J. Hallux rigidus. EFORT Open Rev 2017; 2: 13-20
• 8 McNeil DS, Baumhauer JF, Glazebrook MA. Evidence-based analysis of the efficacy for operative treatment of hallux rigidus. Foot Ankle Int 2013; 34: 15-32
• 9 Rammelt S, Panzner I, Mittlmeier T. Metatarsophalangeal Joint Fusion: Why and How?. Foot Ankle Clin 2015; 20: 465-477
• 10 Baumhauer JF, Singh D, Glazebrook M. et al. 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; 37: 457-469
• 11 Daniels TR, Younger AS, Penner MJ. et al. Midterm Outcomes of Polyvinyl Alcohol Hydrogel Hemiarthroplasty of the First Metatarsophalangeal Joint in Advanced Hallux Rigidus. Foot Ankle Int 2017; 38: 243-247
• 12 Glazebrook M, Blundell CM, OʼDowd D. et al. Midterm Outcomes of a Synthetic Cartilage Implant for the First Metatarsophalangeal Joint in Advanced Hallux Rigidus. Foot Ankle Int 2019; 40: 374-383 doi:10.1177/1071100718815469
• 13 Eble SK, Hansen OB, Chrea B. et al. Clinical Outcomes of the Polyvinyl Alcohol (PVA) Hydrogel Implant for Hallux Rigidus. Foot Ankle Int 2020; 41: 1056-1064
• 14 Chrea B, Eble SK, Day J. et al. Comparison Between Polyvinyl Alcohol Implant and Cheilectomy With Moberg Osteotomy for Hallux Rigidus. Foot Ankle Int 2020; 41: 1031-1040
• 15 An TW, Cassinelli S, Charlton TP. et al. Radiographic and Magnetic Resonance Imaging of the Symptomatic Synthetic Cartilage Implant. Foot Ankle Int 2020; 41: 25-30
• 16 Munro BH. Statistical Methods for Health Care Research. 5th ed. Philadelphia: Lippincott Williams & Wilkins; 2005: 248-249
• 17 Glazebrook M, Baumhauer JF, Blundell C. et al. Letter Regarding: Early Outcomes and Complications of Synthetic Cartilage Implant for Treatment of Hallux Rigidus in the United States. Foot Ankle Int 2019; 40: 1149-1151
• 18 Brandao B, Aljawadi A, Hall A. et al. Cartiva case series: The efficacy of the cartiva synthetic cartilage implant interpositional arthroplasty at one year. J Orthop 2020; 20: 338-341
• 19 Cassinelli SJ, Chen S, Charlton TP. et al. Early Outcomes and Complications of Synthetic Cartilage Implant for Treatment of Hallux Rigidus in the United States. Foot Ankle Int 2019; 40: 1140-1148 doi:10.1177/1071100719855049
• 20 Shimozono Y, Hurley ET, Kennedy JG. Early Failures of Polyvinyl Alcohol Hydrogel Implant for the Treatment of Hallux Rigidus. Foot Ankle Int 2020; DOI: 10.1177/1071100720962482.
• 21 Park CW, Seo SW, Kang N. et al. Artificial Intelligence in Health Care: Current Applications and Issues. J Korean Med Sci 2020; 35: e379
• 22 Baumhauer JF, Singh D, Glazebrook M. et al. Correlation of Hallux Rigidus Grade With Motion, VAS Pain, Intraoperative Cartilage Loss, and Treatment Success for First MTP Joint Arthrodesis and Synthetic Cartilage Implant. Foot Ankle Int 2017; 38: 1175-1182
• 23 Baumhauer JF, Daniels T, Glazebrook M. New Technology in the Treatment of Hallux Rigidus with a Synthetic Cartilage Implant Hemiarthroplasty. Orthop Clin North Am 2019; 50: 109-118
• 24 Younger AS, Baumhauer JF, Glazebrook M. Polyvinyl alcohol hemiarthroplasty for first metatarsophalangeal joint arthritis. Curr Orthop Pract 2013; 24: 493-497
• 25 Younger SE, Baumhauer J. Polyvinyl Alcohol Hydrogel Hemiarthroplasty of the Great Toe: Technique and Indications. Techn Foot Ankle Surg 2013; 12: 164-169