一项评估悬浮式三室卸载式膝关节支架治疗多室膝关节骨性关节炎的可行性随机试验。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Emily L Bishop, Justin Bonhomme, Molly Joffe, Chris Cowper-Smith, Janet L Ronsky, Marcia L Clark
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引用次数: 0

摘要

背景:Levitation™“三室Offloader”(TCO)膝关节支架(弹簧加载技术)旨在减轻膝关节骨性关节炎(OA)患者的疼痛。TCO在市场上是可用的,然而,还没有通过对照临床试验将其与目前膝关节OA的护理治疗标准进行比较。本可行性研究旨在(i)评估进行全随机对照试验的可行性,(ii)评估视觉模拟量表(VAS)活动特异性膝关节疼痛评分的分布特性,以估计全随机对照试验(RCT)所需的样本量,以及(iii)完善和优化研究方案。方法:在加拿大阿尔伯塔卡尔加里大学(University of Calgary)进行了一项前瞻性、3组、平行、单中心可行性随机对照试验,研究对象为中度至重度髌骨或多室膝关节OA患者。参与者按1:1:1随机分配到三个干预组之一:标准护理组(Control)、对照组加膝套组(sleeve)或对照组加TCO支具组(TCO)。参与者在基线(干预前)和控制干预6周和3个月(主要终点)后进行评估。完整RCT的样本量是根据基线至3个月间VAS膝关节疼痛的变化来估计的。可行性评估采用参与者招募、干预依从性、参与者反应率、数据质量、辍学率和不良事件。在整个研究期间,所有的方案变更都被记录下来。结果:29名参与者(女性13名;年龄:62±9岁)。完整RCT的估计样本量为93人(每组31人)。参与者表现出较高的干预依从性,3个月时随访率为86%。4名参与者退出了研究,报告了3起不良事件。对受试者资格标准、招募策略和数据收集方法进行了修改,以提高完整随机对照试验的可行性、效率和适宜性。结论:本研究支持了一项全面的随机对照试验的可行性,该试验评估了TCO膝关节支具与目前(保守的)膝关节OA患者标准护理治疗的临床有效性,并且现在需要一项足够有力的随机对照试验。试验注册:ClinicalTrials.gov, ID: NCT05543486。注册日期:2022年9月15日-追溯注册,https://clinicaltrials.gov/study/NCT05543486。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

A feasibility randomised trial evaluating the levitation tri-compartment offloader knee brace for multicompartment knee osteoarthritis.

A feasibility randomised trial evaluating the levitation tri-compartment offloader knee brace for multicompartment knee osteoarthritis.

A feasibility randomised trial evaluating the levitation tri-compartment offloader knee brace for multicompartment knee osteoarthritis.

A feasibility randomised trial evaluating the levitation tri-compartment offloader knee brace for multicompartment knee osteoarthritis.

Background: The Levitation™ "Tri-Compartment Offloader" (TCO) knee brace (Spring Loaded Technology) is designed to reduce pain for individuals with knee osteoarthritis (OA). The TCO is available on the market, however, has not been compared to the current standard of care treatment for knee OA with a controlled clinical trial. This feasibility study aimed to (i) evaluate the feasibility of conducting a full RCT, (ii) evaluate the distributional properties of the Visual Analog Scale (VAS) activity-specific knee pain score to estimate the sample size required for a full randomised controlled trial (RCT), and (iii) refine and optimise the study protocol.

Methods: A prospective, 3-group, parallel, single-centre feasibility RCT of individuals with moderate to severe patellofemoral or multicompartment knee OA was undertaken at the University of Calgary (Alberta, Canada). Participants were randomised using a 1:1:1 random allocation to one of three intervention groups: standard of care (Control), Control plus a knee sleeve (Sleeve), or Control plus a TCO brace (TCO). Participants were assessed at baseline (before intervention) and after 6 weeks and 3 months (primary endpoint) of controlled intervention. The sample size for a full RCT was estimated based on the change in VAS knee pain between baseline and 3 months. Feasibility was assessed using participant recruitment, intervention adherence, participant response rates, data quality, dropout rate and adverse events. All protocol changes made throughout the duration of the study were recorded.

Results: Twenty-nine participants (13 females; age: 62 ± 9 years) were recruited. The estimated sample size for a full RCT is 93 individuals (31 per group). Participants showed high intervention adherence and follow-up rates were 86% at 3 months. Four participants dropped out of the study, and there were 3 adverse events reported. Changes were made to participant eligibility criteria, recruitment strategy and data collection methods to improve feasibility, efficiency, and appropriateness for a full RCT.

Conclusions: This study supports the feasibility of a full scale RCT evaluating the clinical effectiveness of the TCO knee brace compared to the current (conservative) standard of care treatment for individuals with knee OA, and an adequately powered RCT is now warranted.

Trial registration: ClinicalTrials.gov, ID: NCT05543486. Registered 15 September 2022-retrospectively registered, https://clinicaltrials.gov/study/NCT05543486.

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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