Stravinskas Mindaugas, Tarasevicius Sarunas, Laukaitis Simonas, Nilsson Malin, Raina Deepak Bushan, Lidgren Lars
Lithuanian University of Health, Kaunas, Lithuania.
Department of Orthopedics, Lund University Hospital, Lund, Sweden.
BMC Musculoskelet Disord. 2018 Dec 6;19(1):438. doi: 10.1186/s12891-018-2360-8.
The primary objective was to investigate the clinical and radiological outcome in patients undergoing major hip surgery using a novel antibiotic containing bone substitute for local augmentation in trochanteric fracture fixation or revision of total hip arthroplasty (THA).
We implanted a novel biphasic bone substitute CERAMENT™|G consisting of hydroxyapatite, calcium sulphate and gentamicin for bone regeneration and local antibiotic delivery in 20 patients treated surgically for trochanteric femoral fracture or uncemented hip revision. Preoperative, postoperative, 3 months and 1 year clinical and radiological assessment were performed including registration of any complications. In one trochanteric fracture patient, histological analyses were performed of bone biopsies taken at removal of hardware.
None of the trochanteric fractures or revision of THA showed any large migration. No local wound disturbances were seen and no infection was observed at one year follow-up. All trochanteric fractures healed at 3 months with a minimal sliding screw displacement on average 3 mm. Radiological analysis showed signs of bone remodeling and new bone formation in the substitute, illustrated also by histology in the biopsies taken from one trochanteric fracture at one year post-op.
Local CERAMENT™|G was shown to be safe in a limited prospective major hip surgery study. Remodeling of the bone graft substitute was observed in all patients.
EU-CTR2018-004414-18 Retrospectively registered on November 20, 2018.
主要目的是研究在接受大髋关节手术的患者中,使用一种新型含抗生素骨替代物进行转子间骨折固定或全髋关节置换术(THA)翻修时局部增强的临床和放射学结果。
我们为20例接受手术治疗转子间股骨骨折或非骨水泥型髋关节翻修的患者植入了一种新型双相骨替代物CERAMENT™|G,其由羟基磷灰石、硫酸钙和庆大霉素组成,用于骨再生和局部抗生素递送。进行术前、术后、3个月和1年的临床和放射学评估,包括记录任何并发症。在1例转子间骨折患者中,对取出内固定物时获取的骨活检标本进行了组织学分析。
转子间骨折或THA翻修均未显示任何大的移位。未观察到局部伤口问题,1年随访时未发现感染。所有转子间骨折在3个月时愈合,平均滑动螺钉移位最小,为3毫米。放射学分析显示替代物中有骨重塑和新骨形成迹象,1例转子间骨折患者术后1年活检的组织学检查也证实了这一点。
在一项有限的前瞻性大髋关节手术研究中,局部使用CERAMENT™|G被证明是安全的。所有患者均观察到骨移植替代物的重塑。
EU-CTR2018-004414-18,于2018年11月20日进行回顾性注册。