采用富含生长因子的自体制剂治疗骨不连。
Nonunions treated with autologous preparation rich in growth factors.
作者信息
Sanchez Mikel, Anitua Eduardo, Cugat Ramon, Azofra Juan, Guadilla Jorge, Seijas Roberto, Andia Isabel
机构信息
Unidad de Cirugia Artroscópica UCA, Clínica USP-La Esperanza, Vitoria, Spain.
出版信息
J Orthop Trauma. 2009 Jan;23(1):52-9. doi: 10.1097/BOT.0b013e31818faded.
OBJECTIVES
To evaluate the clinical safety and efficacy of using a biologic technology known as preparation rich in growth factors (PRGF) for the treatment of nonhypertrophic nonunion.
DESIGN
The design of the study was a retrospective case series.
SETTING
The private practice was in 2 centers.
PATIENTS
There were 15 patients with a total of 16 aseptic nonunions, 12 diaphyseal and 4 supracondylar, diagnosed as nonhypertrophic. The mean time since prior surgical treatment was 21 months (9-46 months).
INTERVENTION
Supracondylar and diaphyseal nonunions followed surgical fixation with condylar plating or intramedullary nailing, whereas a composite biomaterial created by mixing PRGF with bone allograft was applied. The area was then covered with autologous fibrin membranes. Stable nonunions were treated with repeated percutaneous injections of PRGF; this minimally invasive procedure was also applied if delayed healing was suspected after surgical treatment.
MAIN OUTCOME MEASUREMENTS
Radiographic union using radiographic views was taken in 2 planes. Clinical outcome evaluated pain, motion at the fracture site upon manual stress testing, and recovery of range of motion.
RESULTS
All nonunions treated operatively healed after a single procedure, even though additional PRGF had to be injected in 2 patients. Two of 3 stable nonunions achieved healing only after repeated percutaneous PRGF injections. The mean time from surgery and/or PRGF application to union was 4.9 months (2-8 months). Complications associated with the described procedure were not observed.
CONCLUSION
This study, although uncontrolled, shows that PRGF technology is clinically safe and can enhance the healing of nonhypertrophic nonunions.
目的
评估一种名为富含生长因子制剂(PRGF)的生物技术用于治疗非肥大性骨不连的临床安全性和有效性。
设计
本研究为回顾性病例系列研究。
地点
该私人诊所位于2个中心。
患者
15例患者共16处无菌性骨不连,其中12处骨干骨不连,4处髁上骨不连,均诊断为非肥大性骨不连。距上次手术治疗的平均时间为21个月(9 - 46个月)。
干预
髁上和骨干骨不连采用髁钢板或髓内钉手术固定,同时应用PRGF与同种异体骨混合制成的复合生物材料。然后用自体纤维蛋白膜覆盖该区域。稳定的骨不连采用反复经皮注射PRGF治疗;如果怀疑手术治疗后愈合延迟,也采用这种微创手术。
主要观察指标
在两个平面进行X线摄片以评估骨愈合情况。临床结果评估疼痛、手动应力测试时骨折部位的活动度以及活动范围的恢复情况。
结果
所有接受手术治疗的骨不连在单次手术后均愈合,尽管有2例患者需要额外注射PRGF。3例稳定的骨不连中有2例仅在反复经皮注射PRGF后才实现愈合。从手术和/或应用PRGF到骨愈合的平均时间为4.9个月(2 - 8个月)。未观察到与所述手术相关的并发症。
结论
本研究虽然未设对照,但表明PRGF技术在临床上是安全的,并且可以促进非肥大性骨不连的愈合。