According to a study presented during the Brazilian Spine Society section of Spineweek, Indian pedicle screws are not associated with a significantly higher rate of failure than imported pedicle screws
Abhay Nene, Hinduja National Hospital, Bombay, India, said that the cost of an operation was a common topic of conversation during pre-operative consultations between a spinal surgeon and a patient in India, and the cost of an operation often depended on whether surgeon used imported pedicle screws or used screws made in India.
Nene said that there was little data on the effectiveness of Indian implants, claiming that it was a “taboo subject” and that studies instead concentrated on new, more expensive implants. He added: “Over 90% of implant related studies concluded in favour of the implant used. All of these were sponsored by the implant company.”
In their study, Nene et al compared locally made Indian implant (costing “maybe one third of the imported implants”) with imported implants. Nene reported: “This was a retrospective, observational study with a mean follow-up of 35 months. We studied titanium pedicle screws: we chose the top three selling foreign brands in our city and the top selling Indian brands (CE marked).” The null hypothesis, Nene stated, was that “there was no difference between the implant failure rate for Indian implants and the failure the rate for foreign implants.”
Of 239 patients studied overall, 111 received foreign implants and 128 received Indian implants (the decision about which implant to use was dependent on whether the patient could afford to pay for a foreign implant). Nene said: “We classified failure as surgery failure, bone or disease failure, or implant failure. We found good or acceptable clinical outcomes in 87% of patients with Indian implants and this was comparable to the clinical outcomes in patients with foreign implants.” He added that there was one implant failure (0.15%) in the foreign implant group and five implant failures in the Indian implant group (0.56%), but there was not a statistically significant difference between the two groups (p=0.2438).
Nene reported, according a survey he and his fellow investigators conducted, that “60% of elite city-based spinal surgeons would use Indian implants in more than 50% of cases.” He commented that unlike arthroplasty, which depends on entirely on the quality of the metal or plastic used, the endpoint of spinal surgery is fusion. He said: “We all know that bad surgery fails more often than bad implants.”
The conclusion of Nene et al study, therefore, was that “Indian implants are a safe and viable option to make spinal surgery cost effective in the Indian scenario.”