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Total knee replacement is an effective method to treat serious knee joint diseases.The rapid development in the technology of artificial knee joints has led to a quickly increasing number of knee replacement surgeries.The clinical results of total knee arthroplasty depend on many factors.These factors include the surgical technique,selection of the patient and design of the prosthesis.Recent development of Chinese artificial knee joints will eventually put these products into the international markets.Before entering the international markets,it is necessary to fully understand the foreign medical regulations and laws,and to prevent from adverse events such as recall litigations,especially in Europe and America.Hence,the quality assurance system of the products and production management system should be promoted.Therefore,the experiences of famous international companies should be used to effectively improve the qualities of Chinese medical devices.The present article reviewed the recent recalls of products of five artificial knee prosthesis enterprises by the Food and Drug Administration (FDA) and analyzed the causes of product recalls and related literatures of adverse events in clinical use.
ABSTRACT
Objective To compare the clinical effects of improved posterolateral minimally invasive approach and traditional posterolateral approach combined with modular femoral head prosthesis in the treatment of femoral neck fractures in the elderly. Methods The study involved 70 patients with femoral neck fractures (26 males and 44 females; at age range of 67-95 years,mean 78.3 years) treated from October 2008 to June 2010.There were 62 patients with fresh femoral neck fractures and eight with old femoral neck fractures (2-4 months post-injury),all of whom were type Ⅲ or Ⅳ fractures according to the Garden' s classification.All surgeries were completed by the same operation group.The improved posterolateral minimally invasive approach group involved 32 patients including 12 males and 20 females and the traditional posterolateral approach group involved 38 patients including 14 males and 24 females.The two groups were compared in aspects of incision size,operative time,perioperative complications,prosthesis stability and hip functional recovery. Results All patients were followed up for an average of 16 weeks (range,12-18 weeks).The differences between the two groups were significant regarding the incision length,perioperative blood loss,and blood product transfusio amount (P ＜0.01 ),but insignificant in operative time ( P ＞ 0.05 ).All patients were able to take weight-bearing walk six weeks postoperatively.The two groups showed significant difference in the hip joint function by Chamley's criteria six weeks postoperatively ( P ＜ 0.05 ),but insignificant difference in the hip joint function by Harris' s criteria at the last follow-up ( P ＜ 0.05). Conclusion The modified posterolateral minimally invasive approach combined with modular femoral head prosthesis is a satisfactory method in treatment of femoral neck fractures in senile patients,for it can result in less intra-operative soft tissue damage and blood loss,as well as shorter rehabilitation time.
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ObjectiveTo evaluate the clinical outcome of new proximal femoral nail antirotation (PFNA) in treatment of subtrochanteric fractures. MethodsThere were 31 patients with traumatic subtrochanteric fractures intramedullarily fixed with PFNA. The patients included 14 males and 17 fe-males at a mean age of 54.6 years (range 34-90 years). According to Seinsheimer classification of sub-trochanteric fractures, 14 patients were with type Ⅱ fractures (including four patients with type ⅡA,seven with type ⅡB and three with type ⅡC), 12 with type Ⅲ fractures (including eight with type ⅢA and four with type ⅢB), two with type Ⅳ fractures and three with type Ⅴ fractures. Close reduction was performed under traction and C-arm fluoroscopy in 26 patients and open reduction through a mini-incision before inserting the nail in five patients due to difficult close reduction. ResultsThe operation lasted for a mean time of 72.5 minutes (range 45-120 minutes), with mean blood loss of 127.5 ml (range 100-350 ml). Of all, 27 patients (87.1%, 27/31) were followed up for a mean duration of 14.3 months (range 8-24 months), which showed fracture union in all patients, with a mean union period of 17.4 weeks (range 10-21 weeks). According to Harris Hip Rate Scale, the results were. excellent in 21 pa-tients, good in two and fair in four, with excellence rate of 85.2% (23/27). ConclusionsPFNA is an effective device for treatment of subtrochanteric fracture, with a high union rate and a low complication rate, for it has advantages of easy use and minor trauma, low bleeding and stable fixation in operation.
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Objective To evaluate the effect of open reduction and internal fixation in treatment of calcaneal fractures in aged patients. Methods Between January 1997 and June 2007,37 patients (41 fractures)at a mean age of68.3 years(60-78 years)with calcaneal fractures underwent surgical operations.According to Sanders classification based on CT scanning.14 fractures were rated as typeⅡ,18 as type Ⅲ and 9 as type Ⅳ.Of all,5 fractures were treated with reconstruction plate,18 with shapeable titanic plate,4 with Y-shaped plate,12 Depuy titanic plate and 2 with AO locking titanic plate plus open reduction and internal fixation.The foot function was evaluated by X-ray,American Orthopedic Foot and Ankle Society(AOFAS)Score and Maryland Foot Score. Results A total of 27 patients (60.9%)with 31 fractures were followed up for 12-48 months(average 27.6 months),which showed that all fractures were healed,with morphous improvement of the calcanus determined by 8 parameters measured in X-ray films.The average active range of motion was 36°of plantar flexion,12°of dorsiflexion,15°of inversion,and 10°of eversion.According to Maryland Foot Score,functional foot score was excellent(90-100 points)in 16 fractures,good(75-89 points)in 13 and fair(50-74 points)in 2,with excellence rate of 94%(29/31). Conclusion Open reduction and intemal fixation can gain good clinical result in severe calcaneal fractures in aged patients with obvious dislocation of posterior articular facet.