دورية أكاديمية
أعرض في EDS

Surgical versus non-surgical treatment of humeral SHAFT fractures compared by a patient-reported outcome: the Scandinavian Humeral diAphyseal Fracture Trial (SHAFT)-a study protocol for a pragmatic randomized controlled trial.

التفاصيل البيبلوغرافية
العنوان: Surgical versus non-surgical treatment of humeral SHAFT fractures compared by a patient-reported outcome: the Scandinavian Humeral diAphyseal Fracture Trial (SHAFT)-a study protocol for a pragmatic randomized controlled trial.
المؤلفون: Karimi D; Department of Orthopedic Surgery, Kolding Hospital, Kolding, Denmark. dennis.karimi@rsyd.dk., Brorson S; Department of Orthopedic Surgery, Centre for Evidence-Based Orthopaedics, Zealand University Hospital, Køge, Denmark.; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark., Midtgaard KS; Department of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway., Fjalestad T; Department of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway., Paulsen A; Department of Orthopedic Surgery, Stavanger University Hospital, Stavanger, Norway., Olerud P; Department of Orthopedic Surgery, Stockholm South General Hospital, Stockholm, Sweden., Ekholm C; Department of Orthopedic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden., Wolf O; Department of Surgical Sciences, Section of Orthopedics, Uppsala University, Uppsala, Sweden., Viberg B; Department of Orthopedic Surgery, Kolding Hospital, Kolding, Denmark.
مؤلفون مشاركون: SHAFT Collaborators
المصدر: Trials [Trials] 2022 Jun 02; Vol. 23 (1), pp. 453. Date of Electronic Publication: 2022 Jun 02.
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Humeral Fractures*/surgery, Aged ; Fracture Fixation, Internal/methods ; Humans ; Humerus/surgery ; Multicenter Studies as Topic ; Patient Reported Outcome Measures ; Pragmatic Clinical Trials as Topic ; Randomized Controlled Trials as Topic ; Treatment Outcome
مستخلص: Background: The outcome of non-surgical treatment is generally good, but the treatment course can be long and painful with approximately a quarter of the patients acquiring a nonunion. Both surgical and non-surgical treatment can have disabling consequences such as nerve injury, infection, and nonunion. The purpose of the study is to compare patient-reported outcomes after surgical and non-surgical treatment for humeral shaft fractures.
Methods: A pragmatic randomized controlled trial (RCT) is planned with two study groups (SHAFT-Young and SHAFT-Elderly). A total of 287 eligible acute humeral shaft fractures are scheduled to be recruited and randomly allocated to surgical or non-surgical treatment with the option of early crossover due to delayed union. The surgical method within the allocation is decided by the surgeon. The primary outcome is the Disability of Arm, Shoulder, and Hand (DASH) score at 52 weeks, and is assessor blinded. The secondary outcomes are DASH score, EQ-5D-5L, pain assessed by visual analog score, Constant-Murley score including elbow range of motion, and anchor questions collected at all timepoints throughout the trial. All complications will be reported including; infection, nerve or vascular injury, surgical revisions (implant malpositioning, hardware failure, aseptic loosening, and peri-implant fracture), major adverse cardiovascular events, and mortality.
Discussion: The SHAFT trial is a pragmatic multicenter RCT, that will compare the effectiveness of the main strategies in humeral shaft fracture treatment. This will include a variety of fracture morphologies, while taking the dilemmas within the population into account by splitting the population by age and providing the orthopedic society with an interval for early crossover surgery.
Trial Registration: Clinicaltrials.gov NCT04574336 . Registered on 5 October 2020.
(© 2022. The Author(s).)
References: Am J Ind Med. 1996 Jun;29(6):602-8. (PMID: 8773720)
J Orthop Sci. 2014 Nov;19(6):973-7. (PMID: 25196794)
Cochrane Database Syst Rev. 2011 Jun 15;(6):CD005959. (PMID: 21678350)
Am J Emerg Med. 2020 Aug;38(8):1641-1646. (PMID: 31744654)
J Bone Joint Surg Am. 2000 Apr;82(4):478-86. (PMID: 10761938)
Orthopedics. 2010 Aug 11;33(8):. (PMID: 20704103)
J Shoulder Elbow Surg. 2017 Jan;26(1):e1-e12. (PMID: 27745806)
BMJ. 2013 Jan 08;346:e7586. (PMID: 23303884)
J Shoulder Elbow Surg. 2002 Mar-Apr;11(2):143-50. (PMID: 11988725)
J Bone Joint Surg Am. 2017 Apr 5;99(7):583-592. (PMID: 28375891)
J Orthop Trauma. 2020 Apr;34(4):206-209. (PMID: 31923040)
Shoulder Elbow. 2020 Aug;12(4):229-242. (PMID: 32788928)
Arch Orthop Trauma Surg. 2021 Apr;141(4):561-568. (PMID: 32285189)
J Biomed Inform. 2009 Apr;42(2):377-81. (PMID: 18929686)
PLoS One. 2021 Dec 15;16(12):e0261279. (PMID: 34910791)
J Bone Joint Surg Br. 2006 Nov;88(11):1469-73. (PMID: 17075092)
Int Orthop. 2005 Feb;29(1):10-3. (PMID: 15611875)
JAMA. 2018 Feb 6;319(5):483-494. (PMID: 29411037)
Eur J Orthop Surg Traumatol. 2022 Jan 15;:. (PMID: 35031851)
Qual Life Res. 2005 Aug;14(6):1523-32. (PMID: 16110932)
J Shoulder Elbow Surg. 2020 Jul;29(7):1493-1504. (PMID: 32249144)
Medicine (Baltimore). 2015 Mar;94(11):e599. (PMID: 25789949)
J Bone Joint Surg Am. 1977 Jul;59(5):596-601. (PMID: 873955)
J Shoulder Elbow Surg. 2020 Dec;29(12):2495-2504. (PMID: 32553853)
Trials. 2019 Aug 5;20(1):475. (PMID: 31383027)
Bull World Health Organ. 2001;79(4):373-4. (PMID: 11357217)
BMC Musculoskelet Disord. 2003 Jun 16;4:11. (PMID: 12809562)
Arthritis Care Res (Hoboken). 2012 Mar;64(3):407-14. (PMID: 22162357)
JAMA Surg. 2021 Apr 14;:. (PMID: 33851991)
BMC Musculoskelet Disord. 2016 Apr 12;17:159. (PMID: 27072511)
Orthop Res Rev. 2019 Sep 23;11:141-147. (PMID: 31576178)
Qual Life Res. 2011 Dec;20(10):1727-36. (PMID: 21479777)
J Bone Joint Surg Am. 2014 Mar 5;96(5):403-7. (PMID: 24599202)
Cochrane Database Syst Rev. 2012 Jan 18;1:CD008832. (PMID: 22258990)
Clin Orthop Relat Res. 2009 Apr;467(4):958-65. (PMID: 18587624)
J Shoulder Elbow Surg. 2017 Nov;26(11):1881-1888. (PMID: 29054684)
J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. (PMID: 18218327)
Injury. 2020 Apr;51(4):942-946. (PMID: 32070557)
JAMA. 2020 May 12;323(18):1792-1801. (PMID: 32396179)
J Orthop Trauma. 2017 Dec;31(12):657-662. (PMID: 28708781)
Eur J Trauma Emerg Surg. 2011 Jun;37(3):287-96. (PMID: 21837261)
J Orthop Trauma. 2006 Oct;20(9):597-601. (PMID: 17088660)
J Hand Surg Eur Vol. 2014 Feb;39(2):140-4. (PMID: 23520389)
J Orthop Trauma. 2021 Oct 1;35(10):555-559. (PMID: 33480643)
Thromb Res. 2020 May;189:13-23. (PMID: 32135385)
Med Care. 2003 May;41(5):582-92. (PMID: 12719681)
Biometrics. 1979 Sep;35(3):549-56. (PMID: 497341)
Orthopedics. 2020 May 1;43(3):168-172. (PMID: 32077964)
J Orthop Trauma. 2022 Jun 1;36(6):e227-e235. (PMID: 34999623)
Qual Life Res. 2018 May;27(5):1159-1170. (PMID: 29550964)
J Hand Surg Am. 2005 Sep;30(5):1074.e1-1074.e10. (PMID: 16182070)
Bone Joint J. 2019 Oct;101-B(10):1300-1306. (PMID: 31564159)
J Shoulder Elbow Surg. 2015 Feb;24(2):210-4. (PMID: 25088479)
Clin Orthop Relat Res. 2006 Jan;442:77-82. (PMID: 16394743)
J Trauma. 2007 May;62(5):1157-8. (PMID: 17495717)
BMJ. 2015 May 08;350:h2147. (PMID: 25956159)
J Shoulder Elbow Surg. 2020 May;29(5):1040-1049. (PMID: 31786010)
فهرسة مساهمة: Investigator: K Stohlmann; B Jalal; C Cavallius; ES Pedersen; F Frihagen; F Stensbirk; H Illerström; J Knak; AM Nyholm; J Schønnemann; J Jensen; J Sundkvist; M Vinding; PM Siesing; S Zivanovic; S Kring
Keywords: Delayed union; Diaphyseal fracture; Humeral shaft fracture; Non-surgical; Patient-reported outcomes; Randomized Controlled Trial; Surgical fixation; Treatment
سلسلة جزيئية: ClinicalTrials.gov NCT04574336
تواريخ الأحداث: Date Created: 20220602 Date Completed: 20220606 Latest Revision: 20220716
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC9161482
DOI: 10.1186/s13063-022-06317-6
PMID: 35655280
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-022-06317-6