Did you suffer complications after a Cartiva implant?
Did you suffer complications after a Cartiva implant?
The Cartiva implant is a mainly water-based implant. It is placed in the great toe joint with a hole that is made into the metatarsal head. The implant is pressed fit into the hole and acts similar to regular cartilage, allowing motion of the joint.
Risks associated with implantation of hemiarthroplasty devices or Cartiva Synthetic Cartilage Implant include:
- Shrinking or Migration of the BIG TOE Implant
- Fracture of the BIG TOE Implant
- Nerve Damage in the Big Toe
- Numbness in the Big Toe
- Reduced Range of Motion
- Irritation or Inflammation in the Big Toe
- Severe Big Toe or Foot Pain
- Formation of Cysts in the Big Toe
- Lesions in the Big Toe
- Transfer Metatarsalgia (Pain in your other toes)
- Infection
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Cartiva Implant background and development?
Cartiva, Inc. is a medical device company based in Alpharetta, Ga. Cartiva, Inc. gained FDA premarket approval for Cartiva SCI (surgical cartilage implant) in 2016 with specific indications for treatment of stage four hallux limitus, also known as hallux rigidus. Cartiva, Inc. sold their Cartiva SCI to Wright Medical Inc in a deal valued at $435 million which closed in the final quarter of 2018.
Cartiva, Inc. has provided the medical community with volumes of literature regarding Cartiva SCI through peer-reviewed journal articles and the MOTION study, a study of 197 patients at twelve centers. Take a few minutes to review the literature and I think you’ll be impressed. I was until I started using Cartiva® Implants.
WHAT IS CARTIVA?
The Cartiva implant is a mainly water-based implant. It is placed in the great toe joint with a hole that is made into the metatarsal head. The implant is pressed fit into the hole and acts similar to regular cartilage, allowing motion of the joint.
The procedure is extremely easy to perform and reproducible in the operating room. It is also easy to teach and patients have a fairly rapid recovery after the surgery.
The original studies performed to get FDA clearance was extensive, with over 10 surgeons involved in the study. The results were amazing in the study. Almost all of the patients had pain relief and would do the procedure over again. The study blew my colleagues and me away.
four reasons Cartiva® Implants are prone to impaction failure
Smooth implant surface
The Cartiva implant is made of a remarkably inert substance that shows very little reactivity in the body because the implant is very smooth on all surfaces it creates a functional flaw in the design.
Violation of the subchondral plate
Loss of the support of the subchondral plate with no alternative means of support (like the winged structure of the body of the Swanson Implant) places the Cartiva Implant into the soft metaphyseal bone and is prone to impaction failure.
Lack of osteointegration
Osteointegration, or ingrowth of bone into the implant is described by Rahyussalim as an essential aspect of implant stability. Osteointegration would seem to be an additional starting point for the redesign of the Cartiva Implant.
Placement in bone too soft for support
Over the lifetime of the implant (let’s say 20 years), what is the force applied to the implant and how supportive is the metaphyseal bone? The supporting bone is too weak to provide meaningful, long-term support to resist the load applied to the implant.
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