PDF(Pubmed)
Abstract：
BACKGROUND: Brace treatment is common to address radiological dysplasia in infants with developmental dysplasia of the hip (DDH); however, it is unclear whether bracing provides significant benefit above careful observation by ultrasound. If observation alone is non-inferior to bracing for radiological dysplasia, unnecessary treatment may be avoided. Therefore, the purpose of this study is to determine whether observation is non-inferior to bracing for infants with radiological dysplasia.
METHODS: This will be a multicentre, global, randomised, non-inferiority trial performed under the auspices of a global prospective registry for infants and children diagnosed with DDH. Patients will be included if they present with radiological dysplasia (centred hip, alpha angle 43-60°, percent femoral head coverage greater than 35% measured on ultrasound) of a clinically stable hip under 3 months old. Patients will be excluded if they present with clinical hip instability, have received prior treatment or have known/suspected neuromuscular, collagen, chromosomal or lower-extremity congenital abnormalities or syndromic-associated hip abnormalities. Patients will be enrolled and randomised to undergo observation alone or brace treatment with a Pavlik harness for a minimum of 6 weeks. Follow-up visits will occur at 6 weeks, 1 year and 2 years post-enrolment. The primary outcome will be the norm-referenced acetabular index measured on the 2-year radiograph with a 3° non-inferiority margin. A total of 514 patients will be included.The study is anticipated to start in April 2024 and end in September 2028.The primary outcome will be compared between arms with a mixed-effects model with a random intercept for study centre, and a single covariate for the treatment group. If the lower bound of the 95% CI lies within 3° of the mean, we will treat this as evidence for non-inferiority.
BACKGROUND: Ethics approval has been obtained from the lead site\'s ethics board (University of British Columbia, Children\'s and Women\'s Research Ethics Board). Ethics approval will be obtained from the local ethics committees or institutional review boards at each institution prior to patient enrolment. It is intended that the results of this study shall be published in peer-reviewed journals and presented at suitable conferences.
BACKGROUND: NCT05869851.
METHODS: This will be a multicentre, global, randomised, non-inferiority trial performed under the auspices of a global prospective registry for infants and children diagnosed with DDH. Patients will be included if they present with radiological dysplasia (centred hip, alpha angle 43-60°, percent femoral head coverage greater than 35% measured on ultrasound) of a clinically stable hip under 3 months old. Patients will be excluded if they present with clinical hip instability, have received prior treatment or have known/suspected neuromuscular, collagen, chromosomal or lower-extremity congenital abnormalities or syndromic-associated hip abnormalities. Patients will be enrolled and randomised to undergo observation alone or brace treatment with a Pavlik harness for a minimum of 6 weeks. Follow-up visits will occur at 6 weeks, 1 year and 2 years post-enrolment. The primary outcome will be the norm-referenced acetabular index measured on the 2-year radiograph with a 3° non-inferiority margin. A total of 514 patients will be included.The study is anticipated to start in April 2024 and end in September 2028.The primary outcome will be compared between arms with a mixed-effects model with a random intercept for study centre, and a single covariate for the treatment group. If the lower bound of the 95% CI lies within 3° of the mean, we will treat this as evidence for non-inferiority.
BACKGROUND: Ethics approval has been obtained from the lead site\'s ethics board (University of British Columbia, Children\'s and Women\'s Research Ethics Board). Ethics approval will be obtained from the local ethics committees or institutional review boards at each institution prior to patient enrolment. It is intended that the results of this study shall be published in peer-reviewed journals and presented at suitable conferences.
BACKGROUND: NCT05869851.
摘要：
背景：在患有发育性髋关节发育不良（DDH）的婴儿中，应对放射学发育不良的治疗很常见；然而，目前尚不清楚支撑是否比超声仔细观察具有显著益处.如果单独观察不劣于放射学发育不良的支撑，可以避免不必要的治疗。因此,这项研究的目的是确定放射学发育不良婴儿的观察是否不劣于支撑。
方法：这将是一个多中心，全球,随机化，非劣效性试验是在一项全球前瞻性登记机构的主持下,针对被诊断为DDH的婴儿和儿童进行的.如果患者存在放射学发育不良(中心髋关节，α角43-60°,超声测量的股骨头覆盖率大于35％）3个月以下临床稳定的髋关节。如果患者存在临床髋关节不稳定，将被排除在外。以前接受过治疗或已知/怀疑有神经肌肉，胶原蛋白，染色体或下肢先天性异常或综合征相关髋关节异常。患者将被招募并随机接受单独观察或用Pavlik安全带进行至少6周的支撑治疗。随访将在6周进行，入学后1年和2年。主要结果将是在2年X线片上测量的标准参考髋臼指数，其边缘为3°。总共将包括514名患者。该研究预计于2024年4月开始，并于2028年9月结束。主要结果将在具有混合效应模型的arms之间进行比较，该模型具有随机截获的研究中心，和治疗组的单个协变量。如果95%CI的下限位于平均值的3°以内，我们将把这当作非劣效性的证据.
背景：已从牵头站点的道德委员会获得道德批准（不列颠哥伦比亚大学，儿童和妇女研究伦理委员会)。在患者登记之前，将从每个机构的当地伦理委员会或机构审查委员会获得伦理批准。本研究的结果应在同行评审的期刊上发表，并在适当的会议上发表。
背景：NCT05869851。
方法：这将是一个多中心，全球,随机化，非劣效性试验是在一项全球前瞻性登记机构的主持下,针对被诊断为DDH的婴儿和儿童进行的.如果患者存在放射学发育不良(中心髋关节，α角43-60°,超声测量的股骨头覆盖率大于35％）3个月以下临床稳定的髋关节。如果患者存在临床髋关节不稳定，将被排除在外。以前接受过治疗或已知/怀疑有神经肌肉，胶原蛋白，染色体或下肢先天性异常或综合征相关髋关节异常。患者将被招募并随机接受单独观察或用Pavlik安全带进行至少6周的支撑治疗。随访将在6周进行，入学后1年和2年。主要结果将是在2年X线片上测量的标准参考髋臼指数，其边缘为3°。总共将包括514名患者。该研究预计于2024年4月开始，并于2028年9月结束。主要结果将在具有混合效应模型的arms之间进行比较，该模型具有随机截获的研究中心，和治疗组的单个协变量。如果95%CI的下限位于平均值的3°以内，我们将把这当作非劣效性的证据.
背景：已从牵头站点的道德委员会获得道德批准（不列颠哥伦比亚大学，儿童和妇女研究伦理委员会)。在患者登记之前，将从每个机构的当地伦理委员会或机构审查委员会获得伦理批准。本研究的结果应在同行评审的期刊上发表，并在适当的会议上发表。
背景：NCT05869851。
