英国牛津大学Matthew L Costa团队取得一项新突破。他们的研究比较了石膏固定与功能支具非手术治疗跟腱断裂的效果和费用。相关论文发表在2020年2月8日出版的《柳叶刀》杂志上。

跟腱断裂患者的非手术治疗传统上是采用石膏模固定跟腱数周。功能支具是一种替代性的非手术治疗方法，可允许患者早日活动，但其有效性和安全性仍有待考证。

2016年8月15日至2018年5月31日，研究组在英国的39家医院开展了一项实用性、优越性、多中心、随机对照试验，招募了540名原发性跟腱断裂非手术治疗的患者，平均年龄为48.7岁，79%为男性。将其随机分组，其中266名接受石膏模固定，274名接受功能支具。

最终有527人纳入意向分析。损伤9个月后，石膏组的跟腱断裂评分为74.4分，功能支具组为72.8分，差异无统计学意义。石膏组有6%的患者发生跟腱再断裂，功能支具组有5%，差异不显著。石膏组的平均花费为1181英镑，功能支具组为1078英镑。

总之，对于非手术治疗的跟腱断裂患者，采用传统石膏固定的早期负重疗效并不优于功能支具。患者采用功能支具进行早期负重锻炼安全又经济。

附：英文原文

Title: Plaster cast versus functional brace for non-surgical treatment of Achilles tendon rupture (UKSTAR): a multicentre randomised controlled trial and economic evaluation

Author: Matthew L Costa, Juul Achten, Ioana R Marian, Susan J Dutton, Sarah E Lamb, Benjamin Ollivere, Mandy Maredza, Stavros Petrou, Rebecca S Kearney, Amr Abdallah, Moez Ballal, Jordi Ballester, James Beastall, Rajarshi Bhattacharya, Simon Burrt, Mark Deakin, Rupe Deol, Asterios Dramis, Sameh El-Kawy, Jason Eyre, Justin Forder, Avijeet Ghosh, Anhijit Guha, Nicholas Hancock, Fraser Harrold, Paul Harwood, Peter Hull, Alan Johnstone, Sandeep Kapoor, Babis Karagkevrekis, Andrew Kelly, Nasser Kurdy, Harish Kurup, Victoria Lyle, Sanjeev Madan, Jane Madeley, Ansar Mahmood, Atif Malik, Andrew McAndrew, Viren Mishra, Nitin Modi, Rajesh Nanda, Ines Reichert, Nikos Reissis, Sridhar Sampalli, Andrea Scott, Richard Walter, Mark Westwood

Issue&Volume: 2020/02/08

Abstract: 

Background
Patients with Achilles tendon rupture who have non-operative treatment have traditionally been treated with immobilisation of the tendon in plaster casts for several weeks. Functional bracing is an alternative non-operative treatment that allows earlier mobilisation, but evidence on its effectiveness and safety is scarce. The aim of the UKSTAR trial was to compare functional and quality-of-life outcomes and resource use in patients treated non-operatively with plaster cast versus functional brace.
Methods
UKSTAR was a pragmatic, superiority, multicentre, randomised controlled trial done at 39 hospitals in the UK. Patients (aged ≥16 years) who were being treated non-operatively for a primary Achilles tendon rupture at the participating centres were potentially eligible. The exclusion criteria were presenting more than 14 days after injury, previous rupture of the same Achilles tendon, or being unable to complete the questionnaires. Eligible participants were randomly assigned (1:1) to receive a plaster cast or functional brace using a centralised web-based system. Because the interventions were clearly visible, neither patients nor clinicians could be masked. Participants wore the intervention for 8 weeks. The primary outcome was patient-reported Achilles tendon rupture score (ATRS) at 9 months, analysed in the modified intention-to-treat population (all patients in the groups to which they were allocated, excluding participants who withdrew or died before providing any outcome data). The main safety outcome was the incidence of tendon re-rupture. Resource use was recorded from a health and personal social care perspective. The trial is registered with ISRCTN, ISRCTN62639639.
Findings
Between Aug 15, 2016, and May 31, 2018, 1451 patients were screened, of whom 540 participants (mean age 48·7 years, 79% male) were randomly allocated to receive plaster cast (n=266) or functional brace (n=274). 527 (98%) of 540 were included in the modified intention-to-treat population, and 13 (2%) were excluded because they withdrew or died before providing any outcome data. There was no difference in ATRS at 9 months post injury (cast group n=244, mean ATRS 74?4 [SD 19?8]; functional brace group n=259, ATRS 72?8 [20?4]; adjusted mean difference –1?38 [95% CI –4?9 to 2?1], p=0·44). There was no difference in the rate of re-rupture of the tendon (17 [6%] of 266 in the plaster cast group vs 13 [5%] of 274 in the functional brace group, p=0·40). The mean total health and personal social care cost was £1181 for the plaster cast group and £1078 for the functional bract group (mean between-group difference –£103 [95% CI –289 to 84]).
Interpretation
Traditional plaster casting was not found to be superior to early weight-bearing in a functional brace, as measured by ATRS, in the management of patients treated non-surgically for Achilles tendon rupture. Clinicians may consider the use of early weight-bearing in a functional brace as a safe and cost-effective alternative to plaster casting.

DOI: 10.1016/S0140-6736(19)32942-3

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32942-3/fulltext