Cartiva Toe Implant Results in More Post-Operative Pain, But May Improve Outcomes: Study

The preliminary findings of an ongoing study warns that side effects of a Cartiva toe implant, which has been marketed as a breakthrough treatment for cartilage loss due to big toe arthritis, may result in significantly increased post-operative pain. However, the procedure can restore some motion and result in better long-term outcomes compared to some other treatment options.

The Cartiva SCI is a molded cylindrical implant made of polyvinyl alcohol-based hydrogel (PVA), which has been promoted as a revolutionary toe implant since it was introduced. However, only a few years later the toe implant failure rates have caused widespread complications, including reports of severe toe pain, loosening, fracture and other problems, often result in the need for a toe fusion surgery. This has led some users to file Cartiva toe implant lawsuits, alleging that the manufacturers failed to warn about the potential risks.

In a new study, researchers report that using the Cartiva SCI toe implant instead of simply fusing the joint in place improved the likelihood of restoring or maintaining range of motion. However, patients had to endure more pain after the procedure. The findings of the study were published last month in Foot & Ankle International.

Cartiva Toe Implant Pain After Surgery

The Cartiva toe implant is placed in the first joint of the big toe, known as the first metatarsophalangeal joint, when arthritis has caused the cartilage in that joint to degrade, which can result in severe pain. The condition is known as hallux limitus or hallus rigidus. It affects about 2.2 million people in the U.S. This type of procedure, replacing the first toe joint with an implant, is known as a hemiarthroplasty.

The synthetic cartilage implant is designed to provide cushioning to replace the degraded cartilage and provide pain relief. It is considered an alternative to fusing the joint, a procedure known as arthrodesis, which has a longer healing time and is a more complicated surgical procedure.

In this latest study, researchers looked at 100 patients who underwent either Cartiva hemiarthroplasty, arthrodesis (fusing of the joint), or interpositional arthroplasty. They looked at pre- and post-operative pain between the groups using the Visual Analog Scale (VAS) pain score, and the American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot Rating System.

According to the findings of the study, which is still ongoing, Cartiva surgery complications were most reported among Cartiva recipients, with researchers finding  these patients experienced more post-operative pain than the other two groups of patients on both pain scales.

“The greatest improvement in derived AOFAS score was seen in the arthrodesis and interpositional arthroplasty groups, indicating a better overall combination of post-operative pain, function, and alignment when compared to patients who underwent hemiarthroplasty with Cartiva implant,” the researchers concluded. “While this study is not yet complete, it appears that hemiarthroplasty with Cartiva implant may allow patients to maintain motion in the 1st MTP joint, but at the cost of increased post-operative pain.”

Cartiva Toe Implant Lawsuits

The Cartiva SCI received premarket approval based on its “substantial equivalence” to arthrodesis. However, some critics point out that they are completely different procedures. Results of a clinical study leading to approval, known as the “Motion” study, was a non-inferiority clinical trial comparing the implant to arthrodesis. However, the results have never been duplicated and the failure rate is much higher than the Motion study predicted, according to follow-up studies.

One such study, published by researchers from Cedar Sinai Hospital in 2019, found that 30% of Cartiva SCI recipients were either dissatisfied or very dissatisfied with the outcomes of the procedure. The study found 50% required a corticosteroid injection after the receiving the implant.

In addition to implant loosening, Cartiva SCI complications have been linked to persistent pain, infection, implant fracture, osteolysis, bone over-production, cyst formation, silastic granulomas and transfer metatarsalgia. In some cases, device failure could lead to joint removal.

As a result of purported design defects, lawyers are now reviewing potential Cartiva lawsuits against the manufacturer, alleging that users and the medical community were not adequately warned about the risk of severe post-operative pain and high Cartive toe implant failure rates.