Mortensen Jacob Fyhring, Rasmussen Lasse Enkebølle, Østgaard Svend Erik, Kappel Andreas, Madsen Frank, Schrøder Henrik Morville, Odgaard Anders
Department of Orthopedic Surgery, Copenhagen University Hospital Herlev-Gentofte, Kildegårdsvej 28, DK-2900, Hellerup, Denmark.
Department of Orthopedic Surgery, Vejle Hospital, Kabbeltoft 25, DK-7100, Vejle, Denmark.
BMC Musculoskelet Disord. 2019 Mar 20;20(1):119. doi: 10.1186/s12891-019-2508-1.
In treatment of isolated medial unicondylar osteoarthritis of the knee, it is possible to choose between medial unicondylar knee arthroplasty (mUKA), or a total knee prosthesis (TKA). The demand for a blinded multicenter RCT with the comparison of mUKA and TKA has been increasing in recent years, to determine which prosthesis is better. Supporters of TKA suggest this treatment gives a more predictable and better result, whereas supporters of UKA suggest it is unnecessary to remove functional cartilage in other compartments. If the mUKA is worn or loosens, revision surgery will be relatively easy, whereas revision-surgery after a TKA can be more problematic.
A double-blinded multicenter Randomized Clinical Trial setup is the aim of the study. 6 hospitals throughout all 5 municipal regions of Denmark will be participating in the study. 350 patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 20 years.
Results will be assessed in terms of 1) PROM-questionnaires, 2) Clinical assessment of knee condition, 3) cost analysis. To avoid bias, all participants except the theatre-staff will be blinded.
OKS, KOOS, SF36, Forgotten Joint Score, EQ5D, UCLA activity scale, Copenhagen Knee ROM scale, and Anchor questions. Publications are planned at 2, 5 and 10 years after inclusion of the last patient. The development of variables over time will be analyzed by calculating the area under the curve (AUC) for the variable relative to the initial value, and comparisons of the between-group differences will be based on parametric statistics. In this study, we feel that we have designed a study that will address these concerns with a well-designed double-blinded multicentre RCT.
ClinicalTrials.gov ID: NCT03396640 . Initial Release: 09/19/2017. Date of enrolment of first participant: 10/11/17.
在治疗膝关节单纯内侧髁骨关节炎时，可以选择内侧单髁膝关节置换术（mUKA）或全膝关节置换术（TKA）。近年来，对比较mUKA和TKA的双盲多中心随机对照试验（RCT）的需求不断增加，以确定哪种假体更好。TKA的支持者认为这种治疗方法能带来更可预测且更好的效果，而UKA的支持者则认为没有必要切除其他关节间室的功能性软骨。如果mUKA磨损或松动，翻修手术相对容易，而TKA后的翻修手术可能更具问题。
本研究旨在建立一个双盲多中心随机临床试验。丹麦所有5个行政区的6家医院将参与该研究。将前瞻性纳入350名患者。随访将通过患者报告结局（PROM）问卷和临床检查进行，长达20年。
结果将根据以下方面进行评估：1）PROM问卷；2）膝关节状况的临床评估；3）成本分析。为避免偏倚，除手术人员外，所有参与者都将处于盲态。
牛津膝关节评分（OKS）、膝关节损伤和骨关节炎疗效评分（KOOS）、简明健康状况调查量表（SF36）、遗忘关节评分（Forgotten Joint Score）、欧洲五维度健康量表（EQ5D）、加州大学洛杉矶分校（UCLA）活动量表、哥本哈根膝关节活动度量表（Copenhagen Knee ROM scale）以及锚定问题。计划在纳入最后一名患者后的2年、5年和10年发表研究成果。通过计算变量相对于初始值的曲线下面积（AUC）来分析变量随时间的变化，并基于参数统计对组间差异进行比较。在本研究中，我们认为我们设计了一项研究，将通过精心设计的双盲多中心RCT来解决这些问题。
ClinicalTrials.gov标识符：NCT03396640。首次发布日期：2017年9月19日。第一名参与者的入组日期：2017年10月11日。
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