Expert review of medical devices · 2026
Failure rates of meniscal repairs during anterior cruciate ligament reconstruction using different meniscal repair devices.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Corso Katherine, Smith Caroline, Joyner Patrick
Аннотация
BACKGROUND: Meniscal tears concurrent with anterior cruciate ligament tears affect patients' mobility and quality of life. This study sought to evaluate the meniscal-related reoperation rate by meniscal device.
METHODS: A retrospective, comparative study design was conducted. Using the New Zealand ACL Registry two device groups were identified, patients the received TRUESPAN™ (DePuy Synthes, Raynham MA) (Device A) and patients that received one of two unspecified branded devices (Device B or C). The rate of meniscal-related reoperation was estimated. Cox proportional hazard models were run to compare rates.
RESULTS: Device A group had 1332 patients and Device B/C group had 3105 patients. Device A had a similar reoperation rate as Device B (0.041 versus 0.03 cases/100 person-years, p-value = 0.275) and a statistically significantly lower rate than Device C and B/C (0.131 and 0.125 cases/100 person-years, p <0.001 for both). This trend was similar across age, gender and graft type subgroups. Compared to Device A, Device C and Device B/C had higher reoperation risks (hazard ratio, p-value: 3.995, <0.001; 3.623, <0.001) and Device B had no significantly different risks (0.509, 0.269).
CONCLUSION: Compared to Device A, meniscal reoperation rates were significantly higher in Device C and not significantly different to Device B.
METHODS: A retrospective, comparative study design was conducted. Using the New Zealand ACL Registry two device groups were identified, patients the received TRUESPAN™ (DePuy Synthes, Raynham MA) (Device A) and patients that received one of two unspecified branded devices (Device B or C). The rate of meniscal-related reoperation was estimated. Cox proportional hazard models were run to compare rates.
RESULTS: Device A group had 1332 patients and Device B/C group had 3105 patients. Device A had a similar reoperation rate as Device B (0.041 versus 0.03 cases/100 person-years, p-value = 0.275) and a statistically significantly lower rate than Device C and B/C (0.131 and 0.125 cases/100 person-years, p <0.001 for both). This trend was similar across age, gender and graft type subgroups. Compared to Device A, Device C and Device B/C had higher reoperation risks (hazard ratio, p-value: 3.995, <0.001; 3.623, <0.001) and Device B had no significantly different risks (0.509, 0.269).
CONCLUSION: Compared to Device A, meniscal reoperation rates were significantly higher in Device C and not significantly different to Device B.