大直径金属对金属髋关节置换与髋关节表面置换的前瞻性随机对照研究的中期结果：基于患者报告的结果测量和客观功能任务的结果。
Mid-term results of a prospective randomised controlled trial comparing large-head metal-on-metal hip replacement to hip resurfacing using patient-reported outcome measures and objective functional task-based outcomes.
机构信息
Department of Trauma and Orthopaedics, University College London Hospitals NHS Trust, London, UK.
Department of Orthopaedics, University of British Columbia, Vancouver General Hospital, Vancouver, Canada.
出版信息
Hip Int. 2021 Sep;31(5):637-643. doi: 10.1177/1120700020919671. Epub 2020 May 11.
BACKGROUND
The early outcomes of large head-metal-on-metal total hip arthroplasty (MoM THA) are compromised by adverse local tissue reaction to metal debris. This study is the mid-term follow-up of a prospective randomised control trial (pRCT) comparing MoM THA to MoM HR. We sought to answer whether there was a difference between MoM THA and MoM HR at mid-term follow-up in the implant survival; patient-reported outcome measures (PROMs); and when performing objective functional tasks?
METHODS
A total of 104 patients were studied. Of these 56 had MoM THA (50 male) and 48 had HR (43 male). Mean age at surgery was 52 years in both groups.We reviewed this cohort at mid-term follow-up [minimum 8 years (mean 9 years; range 8-10; SD 0.7)]. PROMs that were completed were OHS, WOMAC, SF-12, and the UCLA. For objective functional task-based outcomes, gait parameters for operated legs were assessed in a subgroup of 17 patients with high UCLA.
RESULTS
Revision rate in MoM THA group was 7/56 (12.5%) and in the HR group was 1/48 (2.1%). Overall revision rate at minimum 8-year follow-up was 7.7% (8 of 104 patients). PROMs data comparing MoM THA versus HR showed no difference between the groups. 4 (8.5%) of the non-revised (47) HR patients had WOMAC function or pain score below 70. 3 (6.4%) patients had both pain and function scores <70. In the THA group, 5 (10.2%) of the non-revised (49) patients had WOMAC pain or function scores <70. 3 (6.1%) patients had both pain and function scores <70. The comparison of HA versus THA showed several gait parameters in the HR group to be better but not statistically significant ( > 0.05 Mann-Whitney U-test).
CONCLUSIONS
At mid-term follow-up, the revision rate of MoM articulation for THA is high (7.7%), being higher in large head MoM total hips versus resurfacing. Overall probability of 10-year survival is 92.3% (KM analysis, 95% for MoM THA and 98% for HR). The HR group had better functional parameters on gait-based tasks compared to THA group but this difference did not reach statistical significance.
背景
大尺寸金属对金属全髋关节置换术（MoM-THA）的早期结果因金属碎屑引起的局部组织不良反应而受到影响。本研究是一项前瞻性随机对照试验（pRCT）的中期随访，比较了 MoM-THA 与 MoM-HR。我们旨在回答在中期随访时，MoM-THA 和 MoM-HR 在植入物存活率、患者报告的结果测量（PROMs）以及执行客观功能任务方面是否存在差异？
方法
共研究了 104 例患者，其中 56 例为 MoM-THA（50 例男性），48 例为 HR（43 例男性）。两组患者的平均手术年龄均为 52 岁。我们对这组患者进行了中期随访[最少 8 年（平均 9 年；范围 8-10；SD 0.7）]。完成的 PROMs 包括 OHS、WOMAC、SF-12 和 UCLA。对于基于客观功能任务的结果，在 UCLA 评分较高的 17 例患者亚组中评估了手术侧下肢的步态参数。
结果
MoM-THA 组的翻修率为 7/56（12.5%），HR 组为 1/48（2.1%）。最低 8 年随访时的总体翻修率为 7.7%（104 例患者中的 8 例）。比较 MoM-THA 与 HR 的 PROMs 数据显示两组之间无差异。47 例非翻修（47 例）HR 患者中有 4 例（8.5%）的 WOMAC 功能或疼痛评分低于 70。3 例（6.4%）患者疼痛和功能评分均<70。在 THA 组中，49 例非翻修（49 例）患者中有 5 例（10.2%）的 WOMAC 疼痛或功能评分低于 70。3 例（6.1%）患者疼痛和功能评分均<70。HA 与 THA 的比较显示 HR 组的几个步态参数更好，但无统计学意义（>0.05 Mann-Whitney U 检验）。
结论
在中期随访时，MoM 关节 THA 的翻修率较高（7.7%），大尺寸 MoM 全髋关节置换术高于表面置换术。10 年生存率的总体概率为 92.3%（KM 分析，MoM-THA 为 95%，HR 为 98%）。与 THA 组相比，HR 组在步态任务的功能参数上有更好的表现，但这一差异没有达到统计学意义。
Zotero 插件