PURPOSE: As Indian spine surgeons, we have to choose between 'foreign implants' and 'Indian implants'. An Indian four pedicle screw rod construct costs 330 US dollars (one-third that of a similar foreign construct). About 60% of patients cannot afford expensive foreign implants. There is little written data evaluating how these Indian implants fare. The purpose of our study was to evaluate implant failure rate with Indian implants and compare it to foreign implants. METHODS: We analysed results of 1,572 titanium pedicle screws used in 239 patients with a minimum 1-year follow-up. Patients were divided into Indian and foreign implant groups. Radiological failures were classified as (1) surgery and disease failure, (2) bone failure and (3) implant failure. The null hypothesis was that there is no difference between implant failure rate for Indian and foreign implants. RESULTS: A total of 128 (53.56%) of patients could not afford foreign implants. We used 679 foreign and 893 Indian pedicle screws. In foreign implant group, there was a single incident of implant failure (0.15%). In Indian implant group, there were five such incidents (0.56%). CONCLUSIONS: (1) Rate of failure for 'low cost' Indian implants is very low (approximately 1 implant complication for every 200 screws). (2) There is no statistically significant difference in failure rates for Indian implants and foreign implants (P-value = 0.2438). We recommend that Indian implants are a safe and viable option to make spine surgery cost effective in the Indian scenario.
PURPOSE: As Indian spine surgeons, we have to choose between 'foreign implants' and 'Indian implants'. An Indian four pedicle screw rod construct costs 330 US dollars (one-third that of a similar foreign construct). About 60% of patients cannot afford expensive foreign implants. There is little written data evaluating how these Indian implants fare. The purpose of our study was to evaluate implant failure rate with Indian implants and compare it to foreign implants. METHODS: We analysed results of 1,572 titanium pedicle screws used in 239 patients with a minimum 1-year follow-up. Patients were divided into Indian and foreign implant groups. Radiological failures were classified as (1) surgery and disease failure, (2) bone failure and (3) implant failure. The null hypothesis was that there is no difference between implant failure rate for Indian and foreign implants. RESULTS: A total of 128 (53.56%) of patients could not afford foreign implants. We used 679 foreign and 893 Indian pedicle screws. In foreign implant group, there was a single incident of implant failure (0.15%). In Indian implant group, there were five such incidents (0.56%). CONCLUSIONS: (1) Rate of failure for 'low cost' Indian implants is very low (approximately 1 implant complication for every 200 screws). (2) There is no statistically significant difference in failure rates for Indian implants and foreign implants (P-value = 0.2438). We recommend that Indian implants are a safe and viable option to make spine surgery cost effective in the Indian scenario.
Authors: K Hasegawa; H E Takahashi; S Uchiyama; T Hirano; T Hara; T Washio; T Sugiura; M Youkaichiya; M Ikeda Journal: Spine (Phila Pa 1976) Date: 1997-05-01 Impact factor: 3.468