PDF(Pubmed)
Abstract：
BACKGROUND: Without surgical repair, flexor tendon injuries do not heal and patients\' ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There are currently three custom-made splints used in the rehabilitation of zone I/II flexor tendon repairs, each with different assumed harm/benefit profiles: the dorsal forearm and hand-based splint (long), the Manchester short splint (short), and the relative motion flexion splint (mini). There is, however, no robust evidence as to which splint, if any, is most clinical or cost effective. The Flexor Injury Rehabilitation Splint Trial (FIRST) was designed to address this evidence gap.
METHODS: FIRST is a parallel group, superiority, analyst-blind, multi-centre, individual participant-randomised controlled trial. Participants will be assigned 1:1:1 to receive either the long, short, or mini splint. We aim to recruit 429 participants undergoing rehabilitation following zone I/II flexor tendon repair surgery. Potential participants will initially be identified prior to surgery, in NHS hand clinics across the UK, and consented and randomised at their splint fitting appointment post-surgery. The primary outcome will be the mean post-randomisation score on the patient-reported wrist and hand evaluation measure (PRWHE), assessed at 6, 12, 26, and 52 weeks post randomisation. Secondary outcome measures include blinded grip strength and active range of movement (AROM) assessments, adverse events, adherence to the splinting protocol (measured via temperature sensors inserted into the splints), quality of life assessment, and further patient-reported outcomes. An economic evaluation will assess the cost-effectiveness of each splint, and a qualitative sub-study will evaluate participants\' preferences for, and experiences of wearing, the splints. Furthermore, a mediation analysis will determine the relationship between patient preferences, splint adherence, and splint effectiveness.
CONCLUSIONS: FIRST will compare the three splints with respect to clinical efficacy, complications, quality of life and cost-effectiveness. FIRST is a pragmatic trial which will recruit from 26 NHS sites to allow findings to be generalisable to current clinical practice in the UK. It will also provide significant insights into patient experiences of splint wear and how adherence to splinting may impact outcomes.
BACKGROUND: ISRCTN: 10236011.
METHODS: FIRST is a parallel group, superiority, analyst-blind, multi-centre, individual participant-randomised controlled trial. Participants will be assigned 1:1:1 to receive either the long, short, or mini splint. We aim to recruit 429 participants undergoing rehabilitation following zone I/II flexor tendon repair surgery. Potential participants will initially be identified prior to surgery, in NHS hand clinics across the UK, and consented and randomised at their splint fitting appointment post-surgery. The primary outcome will be the mean post-randomisation score on the patient-reported wrist and hand evaluation measure (PRWHE), assessed at 6, 12, 26, and 52 weeks post randomisation. Secondary outcome measures include blinded grip strength and active range of movement (AROM) assessments, adverse events, adherence to the splinting protocol (measured via temperature sensors inserted into the splints), quality of life assessment, and further patient-reported outcomes. An economic evaluation will assess the cost-effectiveness of each splint, and a qualitative sub-study will evaluate participants\' preferences for, and experiences of wearing, the splints. Furthermore, a mediation analysis will determine the relationship between patient preferences, splint adherence, and splint effectiveness.
CONCLUSIONS: FIRST will compare the three splints with respect to clinical efficacy, complications, quality of life and cost-effectiveness. FIRST is a pragmatic trial which will recruit from 26 NHS sites to allow findings to be generalisable to current clinical practice in the UK. It will also provide significant insights into patient experiences of splint wear and how adherence to splinting may impact outcomes.
BACKGROUND: ISRCTN: 10236011.
摘要：
背景：没有手术修复，屈肌腱损伤不能愈合，患者弯曲手指和抓握物体的能力受损。然而,屈肌腱修复手术也需要最佳的康复。目前有三种定制的夹板用于修复I/II区屈肌腱修复，每个人都有不同的假定伤害/益处概况：前臂背侧和手基夹板（长），曼彻斯特短夹板（短），和相对运动屈曲夹板（迷你）。有,然而,没有有力的证据表明是哪一根夹板,如果有的话,是最具临床或成本效益的。Flexor损伤康复夹板试验（FIRST）旨在解决这一证据空白。
方法：首先是一个平行组，优越性,分析师盲，多中心,个体参与者随机对照试验。参与者将被分配为1:1:1接收长，短,或迷你夹板。我们的目标是招募429名在I/II区屈肌腱修复手术后接受康复的参与者。潜在的参与者将在手术前初步确定，在英国各地的NHS手部诊所，并在手术后的夹板安装预约中同意并随机分配。主要结局将是患者报告的腕部和手部评估措施（PRWHE）的平均随机化后评分，在随机分组后6、12、26和52周进行评估。次要结果指标包括盲法握力和活动范围（AROM）评估，不良事件,坚持夹板协议（通过插入夹板的温度传感器测量），生活质量评估，和进一步的患者报告的结果。经济评估将评估每个夹板的成本效益，定性子研究将评估参与者的偏好，和穿着的经验，夹板。此外，调解分析将确定患者偏好之间的关系，夹板粘连，和夹板的有效性。
结论：首先将比较三种夹板的临床疗效，并发症,生活质量和成本效益。FIRST是一项务实的试验，将从26个NHS站点招募，以使研究结果可推广到英国当前的临床实践。它还将提供有关患者佩戴夹板的经验以及坚持夹板可能如何影响结果的重要见解。
背景：ISRCTN：10236011。
方法：首先是一个平行组，优越性,分析师盲，多中心,个体参与者随机对照试验。参与者将被分配为1:1:1接收长，短,或迷你夹板。我们的目标是招募429名在I/II区屈肌腱修复手术后接受康复的参与者。潜在的参与者将在手术前初步确定，在英国各地的NHS手部诊所，并在手术后的夹板安装预约中同意并随机分配。主要结局将是患者报告的腕部和手部评估措施（PRWHE）的平均随机化后评分，在随机分组后6、12、26和52周进行评估。次要结果指标包括盲法握力和活动范围（AROM）评估，不良事件,坚持夹板协议（通过插入夹板的温度传感器测量），生活质量评估，和进一步的患者报告的结果。经济评估将评估每个夹板的成本效益，定性子研究将评估参与者的偏好，和穿着的经验，夹板。此外，调解分析将确定患者偏好之间的关系，夹板粘连，和夹板的有效性。
结论：首先将比较三种夹板的临床疗效，并发症,生活质量和成本效益。FIRST是一项务实的试验，将从26个NHS站点招募，以使研究结果可推广到英国当前的临床实践。它还将提供有关患者佩戴夹板的经验以及坚持夹板可能如何影响结果的重要见解。
背景：ISRCTN：10236011。
