Kleftouris George, Tosounidis Theodoros H, Panteli Michalis, Gathen Martin, Giannoudis Peter V
Academic Department of Trauma and Orthopaedics, School of Medicine, University of Leeds, Leeds LS2 9LU, UK.
Department of Orthopaedic Surgery, University Hospital of Heraklion, 71500 Heraklion, Greece.
J Clin Med. 2023 Jun 23;12(13):4237. doi: 10.3390/jcm12134237.
A prospective, feasibility, randomised study was performed to compare intramedullary versus extramedullary fixation of unstable pertrochanteric fractures and to assess the feasibility of including patients with dementia. From July 2016 to November 2017, 60 consecutive patients with an unstable pertrochanteric (OTA/AO 31-A2) fracture were randomized to either receive a short cephalomedullary nail (Endovis EBA, Citieffe) or a dynamic hip screw (DHS, Zimmer Biomet). Primary feasibility measures included randomisation, recruitment, and retention rates. Secondary outcomes included peri-operative parameters, patient-reported outcomes and radiographic outcomes. Patients were followed-up at two, four, and twelve weeks. There was no difference in the randomisation rate between patients with and without cognitive impairment. Significantly more patients without cognitive impairment attended the 12-week follow-up. The overall recruitment rate was 0.9 patients per week. Patients treated with the nail had less pain at 2 weeks and less neck collapse, medialisation, and leg shortening at all time points. The rest of secondary outcomes were similar. Patients with dementia can successfully be enrolled in a randomised trial on hip fractures. Patients treated with the Endovis nail had lower levels of pain at two weeks and better radiographic outcomes.
进行了一项前瞻性、可行性随机研究,以比较不稳定型股骨转子间骨折的髓内固定与髓外固定,并评估纳入痴呆患者的可行性。2016年7月至2017年11月,60例连续的不稳定型股骨转子间(OTA/AO 31-A2)骨折患者被随机分为两组,分别接受短头髓内钉(Endovis EBA,Citieffe)或动力髋螺钉(DHS,Zimmer Biomet)治疗。主要可行性指标包括随机化、招募和保留率。次要结局包括围手术期参数、患者报告结局和影像学结局。患者在术后2周、4周和12周进行随访。有认知障碍和无认知障碍患者的随机化率无差异。无认知障碍的患者参加12周随访的人数明显更多。总体招募率为每周0.9例患者。接受髓内钉治疗的患者在术后2周时疼痛较轻,在所有时间点的颈部塌陷、内移和下肢缩短情况均较轻。其余次要结局相似。痴呆患者可以成功纳入髋部骨折的随机试验。接受Endovis髓内钉治疗的患者在术后2周时疼痛程度较低,影像学结局较好。