Department of Orthopaedic Surgery, Martini Hospital, P,O, Box 30033, 9700, RM, Groningen, The Netherlands.
BMC Musculoskelet Disord. 2012 Sep 20;13:178. doi: 10.1186/1471-2474-13-178.
Aseptic loosening of total hip arthroplasties is generally caused by periprosthetic bone resorption due to tissue reactions on polyethylene wear particles. In vitro testing of polyethylene cups incorporated with vitamin E shows increased wear resistance. The objective of this study is to compare vitamin E-stabilized highly cross-linked polyethylene with conventional cross-linked polyethylene in "reversed hybrid" total hip arthroplasties (cemented all-polyethylene cups combined with uncemented femoral stems). We hypothesize that the adjunction of vitamin E leads to a decrease in polyethylene wear in the long-term. We also expect changes in bone mineral density, less osteolysis, equal functional scores and increased implant survival in polyethylene cemented cups incorporated with vitamin E in the long-term.
A double-blinded randomized controlled trial will be conducted. Patients to be included are aged under 70, suffer from non-inflammatory degenerative joint disease of the hip and are scheduled for a primary total hip arthroplasty. The study group will receive a reversed hybrid total hip arthroplasty with a vitamin E-stabilized highly cross-linked polyethylene cemented cup. The control group will receive a reversed hybrid total hip arthroplasty with a conventional cross-linked polyethylene cemented cup. Radiological follow-up will be assessed at 6 weeks and at 1, 3, 5, 7 and 10 years postoperatively, to determine polyethylene wear and osteolysis. Patient-reported functional status (HOOS), physician-reported functional status (Harris Hip Score) and patients' physical activity behavior (SQUASH) will also be assessed at these intervals. Acetabular bone mineral density will be assessed by dual energy X-ray absorptiometry (DEXA) at 6 weeks and at 1 year and 2 years postoperatively. Implant survival will be determined at 10 years postoperatively.
In vitro results of vitamin E-stabilized polyethylene are promising, showing increased wear resistance. However, controlled clinical follow-up data are not available at this moment.This randomized controlled trial has been designed to determine wear, bone mineral density, functional outcome and survival in reversed hybrid total hip arthroplasty comparing cemented vitamin E-stabilized highly cross-linked polyethylene cups with cemented conventional cross-linked polyethylene cups.
Dutch Trial Registry NTR3049.
全髋关节置换术后无菌性松动通常是由于聚乙烯磨损颗粒引起的组织反应导致假体周围骨吸收所致。体外试验表明，添加维生素 E 的聚乙烯杯具有更高的耐磨性。本研究旨在比较维生素 E 稳定的高交联聚乙烯与传统交联聚乙烯在“反向混合”全髋关节置换中的应用（骨水泥固定的全聚乙烯杯与非骨水泥固定的股骨柄相结合）。我们假设，添加维生素 E 会导致长期聚乙烯磨损减少。我们还期望在长期使用中，添加维生素 E 的聚乙烯骨水泥固定杯会导致骨密度变化、骨溶解减少、功能评分相等以及植入物存活率增加。
将进行一项双盲随机对照试验。纳入的患者年龄在 70 岁以下，患有非炎症性退行性髋关节疾病，计划进行初次全髋关节置换术。研究组将接受维生素 E 稳定的高交联聚乙烯骨水泥固定杯的反向混合全髋关节置换术。对照组将接受传统交联聚乙烯骨水泥固定杯的反向混合全髋关节置换术。术后 6 周和 1、3、5、7 和 10 年进行放射学随访，以确定聚乙烯磨损和骨溶解情况。还将在这些时间间隔评估患者报告的功能状态（HOOS）、医生报告的功能状态（Harris 髋关节评分）和患者的身体活动行为（SQUASH）。术后 6 周和 1 年、2 年时通过双能 X 线吸收法（DEXA）评估髋臼骨密度。术后 10 年确定植入物存活率。
维生素 E 稳定聚乙烯的体外结果很有希望，显示出更高的耐磨性。然而，目前还没有可用的对照临床试验随访数据。本随机对照试验旨在确定在比较骨水泥固定维生素 E 稳定的高交联聚乙烯杯与骨水泥固定传统交联聚乙烯杯的反向混合全髋关节置换术中，磨损、骨密度、功能结果和存活率。
荷兰试验注册处 NTR3049。
