Moerman Sophie, Mathijssen Nina M C, Niesten Dieu D, Riedijk Roeland, Rijnberg Willard J, Koëter Sander, Kremers van de Hei Keetie, Tuinebreijer Wim E, Molenaar Tim L, Nelissen Rob G H H, Vochteloo Anne J H
Department of Orthopaedics, Reinier de Graaf Group, Reinier de Graafweg 5, 2625 AD, Delft, The Netherlands.
Tergooi hospital, Hilversum, The Netherlands.
BMC Musculoskelet Disord. 2017 Apr 21;18(1):169. doi: 10.1186/s12891-017-1526-0.
It is unclear whether cemented or uncemented hemiarthroplasty is the best treatment option in elderly patients with displaced femoral neck fractures. Previous randomized trials comparing cemented and uncemented hemiarthroplasty have conflicting results. We conducted a randomized controlled trial to compare cemented and uncemented hemiarthroplasty.
This multicenter parallel-randomized controlled trial included patients of 70 years and older with a displaced femoral neck fracture (Garden type III or IV). Inclusion was between August 2008 and June 2012. Patients were randomized between a cemented hemiarthroplasty, type Müller Straight Stem or an uncemented hemiarthroplasty, type DB-10. Primary outcomes were complications, operation time, functional outcome (measured by Timed-Up-and-Go (TUG) and Groningen Activity Restriction Scale (GARS)) and mid-thigh pain. Health Related Quality of Life (HRQoL, expressed with the SF-12) was measured as an secondary outcome. Follow up was 1 year.
In total 201 patients were included in the study (91 uncemented, 110 cemented hemiarthroplasties) The uncemented group showed more major local complications (intra- and postoperative fractures and dislocations) odds ratio (95% confidence interval) 3.36 (1.40 to 8.11). There was no difference in mean operation time (57.3 vs 55.4 min). There were no differences in functional outcomes (TUG 12.8 (9.4) vs. 13.9 (9.0), GARS 43.2 (19.7) vs. 39.2 (16.5)) and mid-thigh pain (18.6 vs 21.6%). Physical component SF-12 HRQoLwas lower in the uncemented group (30.3 vs. 35.3 p < 0.05 after six weeks, 33.8 vs 38.5 p < 0.05 after 12 weeks).
A cemented hemiarthroplasty in elderly patients with a displaced femoral neck fracture results in less complications compared to an uncemented hemiarthroplasty.
Netherlands Trial Registry; NTR 1508 , accepted date 27 okt 2008.
对于老年移位型股骨颈骨折患者,骨水泥型或非骨水泥型半髋关节置换术哪种是最佳治疗选择尚不清楚。以往比较骨水泥型和非骨水泥型半髋关节置换术的随机试验结果相互矛盾。我们进行了一项随机对照试验来比较骨水泥型和非骨水泥型半髋关节置换术。
这项多中心平行随机对照试验纳入了70岁及以上的移位型股骨颈骨折(Garden III型或IV型)患者。纳入时间为2008年8月至2012年6月。患者被随机分为骨水泥型半髋关节置换术(Müller直柄型)或非骨水泥型半髋关节置换术(DB-10型)。主要结局指标为并发症、手术时间、功能结局(采用计时起立行走试验(TUG)和格罗宁根活动受限量表(GARS)测量)以及大腿中部疼痛。将健康相关生活质量(HRQoL,用SF-12表示)作为次要结局指标进行测量。随访时间为1年。
共有201例患者纳入本研究(91例行非骨水泥型半髋关节置换术,110例行骨水泥型半髋关节置换术)。非骨水泥型组出现更多严重局部并发症(术中及术后骨折和脱位),比值比(95%置信区间)为3.36(1.40至8.11)。平均手术时间无差异(57.3分钟对55.4分钟)。功能结局(TUG:12.8(9.4)对13.9(9.0),GARS:43.2(19.7)对39.2(16.5))和大腿中部疼痛(18.6%对21.6%)无差异。非骨水泥型组的身体成分SF-12 HRQoL较低(六周后为30.3对35.3,P<0.05;12周后为33.8对38.5,P<0.05)。
对于老年移位型股骨颈骨折患者,骨水泥型半髋关节置换术比非骨水泥型半髋关节置换术并发症更少。
荷兰试验注册库;NTR 1508,接受日期2008年10月27日。