van Oldenrijk Jakob, Scholtes Vanessa A B, van Beers Loes W A H, Geerdink Carel H, Niers Bob B A M, Runne Wouter, Bhandari Mohit, Poolman Rudolf W
Department of Orthopaedic Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.
Department of Orthopaedic Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
BMJ Open. 2017 Oct 16;7(10):e014522. doi: 10.1136/bmjopen-2016-014522.
Primary aim was to compare the functional results at 3 months and 2 years between short and conventional cementless stem total hip arthroplasty (THA). Secondary aim was to determine the feasibility of a double-blind implant-related trial.
A prospective blinded randomised controlled multicentre trial in patients with osteoarthritis of the hip. All patients, research assistants, clinical assessors, investigators and data analysts were blinded to the type of prosthesis.
150 patients between 18 and 70 years with osteoarthritis of the hip, 75 in the short stem and 75 in the conventional stem group. Mean age: 60 years (SD 7).
the Collum Femoris Preserving short stem versus the Zweymuller Alloclassic conventional stem.
The Dutch version of the Hip Disability and Osteoarthritis Outcome Score (HOOS). Secondary outcomes measures: Harris Hip Score, the Physical Component Scale of the SF12, the Timed Up and Go test, Pain and the EQ-5D. Feasibility outcomes: continued blinding, protocol adherence and follow-up success rate.
No significant difference between the two groups. Mean HOOS total score in the short stem group increased 32.7 points from 36.6 (95% CI 32.9 to 40.2) preoperatively to 69.3 (95% CI 66.4 to 72.1) at 3 months follow-up. Mean HOOS total score in the conventional straight stem group increased 36.3 points from 37.1 (95% CI 33.9 to 40.3) preoperatively to 73.4 (95% CI 70.3 to 76.4) at 3 months follow-up. 91.2% of patients remained blinded at 2 years follow-up. Both protocol adherence and follow-up success rate were 98%.
Functional result at 3 months and 2 years after short stem THA is not superior to conventional cementless THA. There were more perioperative and postoperative complications in the short stem group. Direct comparison of two hip implants in a double-blinded randomised controlled trial is feasible.
NTR1560.
主要目的是比较短柄与传统非骨水泥柄全髋关节置换术(THA)在3个月和2年时的功能结果。次要目的是确定双盲植入物相关试验的可行性。
一项针对髋关节骨关节炎患者的前瞻性盲法随机对照多中心试验。所有患者、研究助理、临床评估者、研究者和数据分析人员均对假体类型不知情。
150例年龄在18至70岁之间的髋关节骨关节炎患者,短柄组75例,传统柄组75例。平均年龄:60岁(标准差7)。
保留股骨颈短柄假体与Zweymuller Alloclassic传统柄假体。
荷兰版髋关节功能障碍和骨关节炎结果评分(HOOS)。次要观察指标:Harris髋关节评分、SF12身体成分量表、计时起立行走测试、疼痛和EQ-5D。可行性指标:持续盲法、方案依从性和随访成功率。
两组之间无显著差异。短柄组的平均HOOS总分从术前的36.6分(95%可信区间32.9至40.2)增加到3个月随访时的69.3分(95%可信区间66.4至72.1)。传统直柄组的平均HOOS总分从术前的37.1分(95%可信区间33.9至40.3)增加到3个月随访时的73.4分(95%可信区间70.3至76.4)。在2年随访时,91.2%的患者仍处于盲态。方案依从性和随访成功率均为98%。
短柄THA术后3个月和2年的功能结果并不优于传统非骨水泥THA。短柄组围手术期和术后并发症更多。在双盲随机对照试验中直接比较两种髋关节植入物是可行的。
NTR1560。