The CARTIVA® SCI is intended for use in the treatment of patients with painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus) in the first metatarsophalangeal joint with or without the presence of mild hallux valgus.*
CARTIVA® SCI should not be implanted in subjects with the following conditions:
- Active infection of the foot
- Known allergy to polyvinyl alcohol
- Inadequate bone stock due to significant bone loss, avascular necrosis, and/or large osteochondral cyst (>1 cm) of the metatarsophalangeal joint
- Lesions of the first metatarsal head greater than 10 mm in size
- Diagnosis of gout with tophi
- Physical conditions that would tend to eliminate adequate implant support (e.g., insufficient quality or quantity of bone resulting from cancer, congenital dislocation, or osteoporosis), systemic and metabolic disorders leading to progressive deterioration of bone (e.g., cortisone therapies or immunosuppressive therapies), and/or tumors of the supporting bone structures
*A hallux valgus angle less than or equal to 20º (greater than 20º was an exclusion criteria in the clinical study).
CARTIVA® SCI vs. Fusion
CARTIVA® SCI does not “burn a bridge” to excellent pain relief and successful functional outcomes, if a revision procedure is needed.7
Burns No Bridges
REVISED CARTIVA® SCI VS. PRIMARY FUSION: EQUIVALENT OUTCOME SCORES7
- Vanore JV, Chirstensen JC, Kravitz ST et al. Diagnosis and Treatment of First Metatarsophalangeal Joint Disorders. 2: Hallux Rigidus. J Foot Ankle Surg. 2003; 42:124-136.
- Coughlin MJ, Shurnas PS. Hallux Rigidus Grading and Long-Term Results of Operative Treatment. Journal of Bone and Joint Surgery. 2003;85A(11):2072-2088.
- Baumhauer JF, Daniels T, Glazebrook M. New Technology in the Treatment of Hallux Rigidus with a Synthetic Cartilage Implant Hemiarthroplasty. Orthopedic Clinics. 2019 Jan 1;50(1):109-18.
- 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(5):457-469.
- Glazebrook, M, Blundell C, O’Dowd D, et al. Midterm Outcomes of a Synthetic Cartilage Implant for the First Metatarsophalangeal Joint in Advanced Hallux Rigidus. Foot Ankle Int. 2019;40(4):374-383.
- Glazebrook MA, Younger ASE, Daniels TR, et al. Treatment of First Metatarsophalangeal Joint Arthritis Using Hemiarthroplasty with a Synthetic Cartilage Implant or Arthrodesis: A Comparison of Operative and Recovery Time. Foot Ankle Surg. 2018 Oct;24(5):440-447.
- Glazebrook M, Baumhauer J, Davies MB. Did We “Burn A Bridge” with a Synthetic Implant Hemiarthroplasty? Foot & Ankle Orthopaedics. 2017;2(3):2473011417S000044.