Department of Orthopaedics, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Rehabilitation Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
PLoS One. 2020 Mar 9;15(3):e0230027. doi: 10.1371/journal.pone.0230027. eCollection 2020.
We described safety and functional one-year follow-up outcomes of individuals with lower limb amputation treated with bone-anchored prostheses using titanium press-fit osseointegration implants.
All consecutive individuals treated between March 2015 and June 2018 with curved osseointegration femur implant (OFI-C) indicated for a long femoral remnant, gamma osseointegration femur implant (OFI-Y) indicated for a short femoral remnant, or osseointegration tibia implant (OTI) were eligible for this study. All adverse events were evaluated, infections were graded as follows: grade 1 and 2: low- and high-grade soft tissue infection, respectively, grade 3: deep bone infection, grade 4: septic implant failure. Functional outcome measures included prosthesis wearing time (PUS), health-related quality of life (GS), and the overall situation as an amputee (GS Q3); evaluated with the Questionnaire of persons with trans-femoral amputation (Q-TFA) before surgery and at one-year follow-up.
Ninety of 91 individuals were included (mean age: 54±14 yrs, 26 females); treated with 53, 16 and 21 OFI-C, OFI-Y and OTI, respectively. Soft tissue infections (grade 1: 11 events, grade 2: 10 events) were treated successfully with antibiotics except in two (OFI-C and OFI-Y), who required additional surgery due to recurrent stoma irritation and peri-stoma abscess drainage. One individual with dysvascular amputation (OTI) developed septic implant loosening and occlusion of the femoral artery resulting in a transfemoral amputation. No aseptic loosening's occurred. One individual (OFI-Y) required stoma surgical refashioning due to soft tissue redundancy. At baseline mean ±SD and median (25th to 75th PCTL) Q-TFA PUS and GS were 52±39, 52(7-90) and 40±19, 42(25-50) and improved significantly to 88±18, 90 (90-100) and 71±15, 75 (67-83) at one-year follow-up. The GS Q3 improved over time.
Titanium osseointegration implants can be safely used within a one-year follow-up period. The performance improved compared to the use of a socket-suspended prosthesis.
我们描述了使用骨锚定假体和钛压配合骨整合植入物治疗下肢截肢患者的安全性和功能一年随访结果。
所有 2015 年 3 月至 2018 年 6 月期间连续接受以下治疗的个体符合研究条件：用于长股骨残端的弯曲骨整合股骨植入物（OFI-C）、用于短股骨残端的伽马骨整合股骨植入物（OFI-Y）或骨整合胫骨植入物（OTI）。所有不良事件均进行评估，感染程度分级如下：1 级和 2 级：分别为低度和高度软组织感染，3 级：深部骨感染，4 级：感染性假体失败。功能结果测量包括假体佩戴时间（PUS）、健康相关生活质量（GS）和作为截肢者的整体情况（GS Q3）；在术前和一年随访时使用股骨假体截肢者问卷（Q-TFA）进行评估。
91 名患者中有 90 名（平均年龄：54±14 岁，26 名女性）纳入研究；分别接受 53、16 和 21 例 OFI-C、OFI-Y 和 OTI 治疗。软组织感染（1 级：11 例，2 级：10 例）除 2 例（OFI-C 和 OFI-Y）外，均采用抗生素成功治疗，这 2 例因造口周围刺激和造口周围脓肿引流而需要额外手术。1 例血管功能不良截肢者（OTI）发生感染性假体松动和股动脉闭塞，导致股骨截肢。无无菌性松动。1 例（OFI-Y）因软组织冗余需要进行造口手术重塑。基线时，Q-TFA PUS 和 GS 的平均值±标准差和中位数（25 至 75 百分位）分别为 52±39、52（7-90）和 40±19、42（25-50），并在一年随访时显著改善至 88±18、90（90-100）和 71±15、75（67-83）。GS Q3 随时间改善。
在一年的随访期内，钛骨整合植入物可以安全使用。与使用插座悬挂假体相比，其性能有所提高。
