初次外侧髌骨脱位患者采用保守与个体化手术治疗的对比：一项随机对照试验。
Conservative versus tailored surgical treatment in patients with first time lateral patella dislocation: a randomized-controlled trial.
机构信息
Department of Orthopaedics and Traumatology, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.
Landeskrankenhaus Feldkirch, Carinagasse 41, 6800, Feldkirch, Austria.
出版信息
J Orthop Surg Res. 2021 Jun 13;16(1):378. doi: 10.1186/s13018-021-02513-3.
BACKGROUND
Patellar instability has a high incidence and occurs particularly in young and female patients. If the patella dislocates for the first time, treatment is usually conservative. However, this cautious approach carries the risk of recurrence and of secondary pathologies such as osteochondral fractures. Moreover, there is also risk of continuous symptoms apparent, as recurrent patella dislocation is related to patellofemoral osteoarthritis as well. An initial surgical treatment could possibly avoid these consequences of recurrent patella dislocation.
METHODS
A prospective, randomized-controlled trial design is applied. Patients with unilateral first-time patella dislocation will be considered for participation. Study participants will be randomized to either conservative treatment or to a tailored patella stabilizing treatment. In the conservative group, patients will use a knee brace and will be prescribed outpatient physical therapy. The surgical treatment will be performed in a tailored manner, addressing the pathologic anatomy that predisposes to patella dislocation. The Banff Patellofemoral Instability-Instrument 2.0, recurrence rate, apprehension test, joint degeneration, and the Patella Instability Severity Score will serve as outcome parameters. The main analysis will focus on the difference in change of the scores between the two groups within a 2-year follow-up. Statistical analysis will use linear mixed models. Power analysis was done for the comparison of the two study arms at 2-year follow-up with regard to the BPII Score. A sample size of N = 64 per study arm (128 overall) provides 80% power (alpha = 0.05, two-tailed) to detect a difference of 0.5 standard deviations in a t-test for independent samples.
DISCUSSION
Although several studies have already dealt with this issue, there is still no consensus on the ideal treatment concept for primary patellar dislocation. Moreover, most of these studies show a unified surgical group, which means that all patients were treated with the same surgical procedure. This is regarded as a major limitation as surgical treatment of patella dislocation should depend on the patient's anatomic pathologies leading to patellar instability. To our knowledge, this is the first study investigating whether patients with primary patella dislocation are better treated conservatively or operatively with tailored surgery to stabilize the patella.
TRIAL REGISTRATION
The study will be prospectively registered in the publicly accessible database www.ClinicalTrials.gov .
背景
髌骨不稳定的发病率较高，尤其多见于年轻女性患者。如果髌骨首次脱位，通常采用保守治疗。然而，这种谨慎的方法存在复发和继发骨软骨骨折等并发症的风险。此外，还存在持续症状的风险，因为复发性髌骨脱位也与髌股关节炎有关。初始手术治疗可能可以避免这些复发性髌骨脱位的后果。
方法
采用前瞻性、随机对照试验设计。将考虑患有单侧初次髌骨脱位的患者参加研究。研究参与者将随机分为保守治疗组或个体化髌骨稳定治疗组。在保守治疗组中，患者将使用膝关节支具，并接受门诊物理治疗。手术治疗将采用个体化方式，针对导致髌骨脱位的病理解剖结构进行治疗。Banff 髌股关节不稳定-仪器 2.0、复发率、恐惧试验、关节退变和髌骨不稳定严重程度评分将作为结局参数。主要分析将集中在两组在 2 年随访期间评分变化的差异上。统计分析将使用线性混合模型。使用线性混合模型进行了功率分析，以比较 2 年随访时两组之间的 BPII 评分。每组 64 名患者（共 128 名患者）的样本量提供了 80%的效能（双侧 α = 0.05），可检测独立样本 t 检验中 0.5 个标准差的差异。
讨论
尽管已经有几项研究涉及这个问题，但对于原发性髌骨脱位的理想治疗概念仍没有共识。此外，这些研究中的大多数都显示出一个统一的手术组，这意味着所有患者都接受了相同的手术治疗。这被认为是一个主要的局限性，因为髌骨脱位的手术治疗应该取决于导致髌骨不稳定的患者解剖病理学。据我们所知，这是第一项研究，旨在调查原发性髌骨脱位患者是通过保守治疗还是通过个体化手术治疗来稳定髌骨更好。
试验注册
该研究将在公开可访问的数据库 www.ClinicalTrials.gov 中进行前瞻性注册。
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