Top

Published in:

Open Access 01-12-2022 | Humeral Shaft Fracture | Study protocol

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

Authors: Dennis Karimi, Stig Brorson, Kaare S. Midtgaard, Tore Fjalestad, Aksel Paulsen, Per Olerud, Carl Ekholm, Olof Wolf, Bjarke Viberg, SHAFT Collaborators

Published in: Trials | Issue 1/2022

Abstract

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.govNCT04574336. Registered on 5 October 2020.

Available only for authorised users

Kim SH, Szabo RM, Marder RA, Marder A. Epidemiology of Humerus Fractures in the United States : Nationwide Emergency Department Sample , 2008. 2012;64(3):407–414.

Bergdahl C, Ekholm C, Wennergren D, Nilsson F, Möller M. Epidemiology and patho-anatomical pattern of 2 , 011 humeral fractures : data from the Swedish Fracture Register. BMC Musculoskelet Disord [Internet]. 2016;1–10. Available from: https://doi.org/10.1186/s12891-016-1009-8

Hudak PL, Amadio PC, Bombardier C. Development of an Upper Extremity Outcome Measure : The DASH ( Disabilities of the Arm , Shoulder , and Head ). 1996;608(1 996).

Aasheim T, Finsen V. The DASH and the QuickDASH instruments. Normative values in the general population in Norway. J Hand Surg Eur. 2014;39(2):140–4.CrossRef

Jester A, Harth A, Germann G. Measuring levels of upper-extremity disability in employed adults using the DASH questionnaire. J Hand Surg Am. 2005;30(5):1074.e1–1074.e10.CrossRef

Zhao J, Wang J, Wang C, Kan S. Intramedullary Nail Versus Plate Fixation for Humeral Shaft Fractures. Syst Rev Overlapping. 2015;94(11):1–8.

Bhandari M, Devereaux PJ, Mckee MD, Schemitsch EH, Bhandari M, Devereaux PJ, et al. Compression plating versus intramedullary nailing of humeral shaft fractures — a meta-analysis Compression plating versus intramedullary nailing of humeral shaft fractures — a meta-analysis. 2009;3674.

Sarmiento A, Zagorski JB, Zych GA, Latta LL, Capps CA. Functional bracing for the treatment of fractures of the humeral diaphysis. J Bone Joint Surg Am. 2000 Apr;82(4):478–86.CrossRef

Harkin FE, Large RJ. Humeral shaft fractures: union outcomes in a large cohort . J Shoulder Elb Surg [Internet]. 2017;26(11):1881–1888. Available from: https://doi.org/10.1016/j.jse.2017.07.001

10.

Rutgers M, Ring D. Treatment of Diaphyseal Fractures of the Humerus Using a Functional Brace. 2006;20(9):597–601.

11.

Denard A, Richards JE, Obremskey WT, Tucker MC, Floyd M, Herzog GA. Outcome of nonoperative vs operative treatment of humeral shaft fractures: A retrospective study of 213 patients. Orthopedics. 2010;33(8).

12.

Ali E, Griffiths D, Frcs T, Obi N, Tytherleigh-strong G, Frcs T, et al. Nonoperative treatment of humeral shaft fractures revisited. J Shoulder Elb Surg [Internet]. 2019;24(2):210–4 Available from: https://doi.org/10.1016/j.jse.2014.05.009.CrossRef

13.

Rämö L, Sumrein BO, Lepola V, Lähdeoja T, Ranstam J, Paavola M, et al. Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial. JAMA [Internet]. 2020 323(18):1792–1801. Available from: https://doi.org/10.1001/jama.2020.3182

14.

Ring D, Chin K, Taghinia AH, Jupiter JB. Nonunion After Functional Brace Treatment of Diaphyseal. J Trauma. 62(5):1157–8.

15.

Rämö L, Paavola M, Sumrein BO, Lepola V, Lähdeoja T, Ranstam J, et al. Outcomes With Surgery vs Functional Bracing for Patients With Closed, Displaced Humeral Shaft Fractures and the Need for Secondary Surgery. JAMA Surg. 2021:1–9.

16.

Oliver WM, Searle HKC, Molyneux SG, White TO, Clement ND, Duckworth AD. Factors associated with patient-reported outcomes following a humeral shaft fracture: Nonunion results in a poorer outcome despite union after surgical fixation. J Orthop Trauma 2022 Jan;

17.

Driesman AS, Fisher N, Karia R, Konda S, Egol KA. Fracture site mobility at 6 weeks after humeral shaft fracture predicts nonunion without surgery. J Orthop Trauma. 2017;31(12):657–62.CrossRef

18.

Pollock FH, Maurer JP, Sop A, Callegai J, Broce M, Kali M, et al. Humeral Shaft Fracture Healing Rates in Older Patients. Orthopedics. 2020 Feb;1–5.

19.

Lode I, Nordviste V, Erichsen JL, Schmal H, Viberg B. Operative versus nonoperative treatment of humeral shaft fractures: a systematic review and meta-analysis. J Shoulder Elb Surg [Internet]. 2020;29(12):2495–2504. Available from: https://doi.org/10.1016/j.jse.2020.05.030

20.

Sargeant HW, Farrow L, Barker S, Kumar K. Operative versus non-operative treatment of humeral shaft fractures: A systematic review. Shoulder Elb. 2020;12(4):229–42.CrossRef

21.

van de Wall BJM, Ochen Y, Beeres FJP, Babst R, Link BC, Heng M, et al. Conservative vs. operative treatment for humeral shaft fractures: a meta-analysis and systematic review of randomized clinical trials and observational studies. J Shoulder Elb Surg. 2020;29(7):1493–504.CrossRef

22.

Hosseini Khameneh SM, Abbasian M, Abrishamkarzadeh H, Bagheri S, Abdollahimajd F, Safdari F, et al. Humeral shaft fracture: a randomized controlled trial of nonoperative versus operative management (plate fixation). Orthop Res Rev. 2019;11:141–7.PubMedPubMedCentral

23.

Matsunaga FT, Tamaoki MJS, Matsumoto MH, Netto NA, Faloppa F, Belloti JC. Minimally invasive osteosynthesis with a bridge plate versus a functional brace for humeral shaft fractures: A randomized controlled trial. J Bone Jt Surg - Am. 2017;99(7):583–92.CrossRef

24.

Kumar S, Shanmugam N, Kumar S, Ramanusan K. Comparison between operative and non operative treatment of fracture shaft of humerus: an outcome analysis. Int J Res Orthop. 2017;3(3):445.CrossRef

25.

Oliver WM, Carter TH, Graham C, White TO, Clement ND, Duckworth AD, et al. A prospective randomised controlled trial of operative versus non-operative management of fractures of the humeral diaphysis : the HUmeral Shaft Fracture FIXation ( HU-FIX ). Study protocol. 2019:1–10.

26.

Gregory K. Berry. Operative and Nonoperative Treatment of Humeral Shaft Fractures [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT00878319

27.

Munro C. SHAFT – Shaft of Humerus Acute Fixation Trial. A study comparing clinical outcomes of the management of arm fractures in adults using non-operative treatment and operative treatment (plates or nails) [Internet]. Available from: https://anzctr.org.au/ACTRN12617001319369.aspx

28.

Gwilym S. HUSH – The HUmeral SHaft fracture trial: A multi-centre prospective randomised superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in patients aged 18 years or older [Internet]. 2020. Available from: https://www.isrctn.com/ISRCTN17108318

29.

Middendorp JJ Van, Kazacsay F, Lichtenhahn P, Renner N, Babst R, Melcher G. Outcomes following operative and non-operative management of humeral midshaft fractures : a prospective , observational cohort study of 47 patients. 2011;287–296.

30.

Kurup H, Hossain M, Jg A, Kurup H, Hossain M, Jg A. Dynamic compression plating versus locked intramedullary nailing for humeral sha fractures in adults. Review. 2011.

31.

Chan A, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. Research methods and reporting spirit 2013 explanation and elaboration : guidance for protocols of clinical trials. 2013;1–42.

32.

Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan AW, King MT. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols the spirit-pro extension. JAMA. 2018;319(5):483–94.CrossRef

33.

Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May;350:h2147.CrossRef

34.

Neer CS. Displaced proximal humeral fractures: part I. Classification and evaluation. 1970. Clin Orthop Relat Res. 2006;442:77–82.CrossRef

35.

AOTrauma International Board representatives: James F. Kellam MD and EGMM. Fracture and dislocation classification compendium - 2018. JOT. 2018. 15–16 p.

36.

Hendrickx LAM, Hilgersom NFJ, Alkaduhimi H, Doornberg JN, van den Bekerom MPJ. Radial nerve palsy associated with closed humeral shaft fractures: a systematic review of 1758 patients. Arch Orthop Trauma Surg [Internet]. 2020;(0123456789). Available from: https://doi.org/10.1007/s00402-020-03446-y

37.

O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549–56.CrossRef

38.

Harris PA, Ph D, Taylor R, Thielke R, Ph D, Payne J, et al. Research Electronic Data Capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support. 2010;42(2):377–381.

39.

Mahabier KC, Den Hartog D, Theyskens N, Verhofstad MHJ, Van Lieshout EMM, Bos PK, et al. Reliability , validity , responsiveness , and minimal important change of the Disabilities of the Arm , Shoulder and Hand and Constant-Murley scores in patients with a humeral shaft fracture. J Shoulder Elb Surg [Internet]. 2017;26(1):e1–12 Available from: https://doi.org/10.1016/j.jse.2016.07.072.CrossRef

40.

Disabilities of arm, shoulder and hand. Available DASH translations. Retrieved from [Internet]. Available from: https://dash.iwh.on.ca/available-translations

41.

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.CrossRef

42.

Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual life Res an Int J Qual life Asp Treat care Rehabil. 2005 Aug;14(6):1523–32.CrossRef

43.

Merrill RK, Low SL, Arvind V, Whitaker CM, Illical EM. Length of stay and 30-day readmissions after isolated humeral shaft fracture open reduction and internal fixation compared to intramedullary nailing. Injury [Internet]. 2020;51(4):942–946. Available from: https://doi.org/10.1016/j.injury.2020.02.001

44.

Kunutsor SK, Barrett MC, Whitehouse MR, Blom AW. Venous thromboembolism following 672 , 495 primary total shoulder and elbow replacements : Meta-analyses of incidence , temporal trends and potential risk factors. Thromb Res [Internet]. 2020;189(December 2019):13–23. Available from: https://doi.org/10.1016/j.thromres.2020.02.018

45.

Bahreini M, Safaie A, Mirfazaelian H, Jalili M. How much change in pain score does really matter to patients? Am J Emerg Med [Internet]. 2020;38(8):1641–1646. Available from: https://doi.org/10.1016/j.ajem.2019.158489

46.

Constant CR, Gerber C, Emery RJH, Søjbjerg JO, Gohlke F, Boileau P. A review of the Constant score: Modifications and guidelines for its use. J Shoulder Elb Surg. 2008;17(2):355–61.CrossRef

47.

Oliver WM, Smith TJ, Nicholson JA, Molyneux SG, White TO, Clement ND, et al. The Radiographic Union Score for HUmeral fractures (RUSHU) predicts humeral shaft nonunion. Bone Jt J. 2019;101-B(10):1300–6.CrossRef

48.

Naal FD, Impellizzeri FM, Leunig M. Which is the best activity rating scale for patients undergoing total joint arthroplasty? Clin Orthop Relat Res. 2009;467(4):958–65.CrossRef

49.

Norman GR. Point / Counterpoint Interpretation of Changes in Health-related Quality of Life. 2003;41(5):582–592.

50.

Neuhaus V, Menendez M, Kurylo JC, Dyer GS, Jawa A, Ring D. Risk factors for fracture mobility six weeks after initiation of brace treatment of mid-diaphyseal humeral fractures. J Bone Jt Surg - Ser A. 2014;96(5):403–7.CrossRef

51.

Ding L, He Z, Xiao H, Chai L, Xue F. Factors affecting the incidence of aseptic nonunion after surgical fixation of humeral diaphyseal fracture. J Orthop Sci. 2014 Nov;19(6):973–7.CrossRef

52.

Serrano R, Mir HR, Sagi HC, Horwitz DS, Ketz JP, Kistler BJ, et al. Modern Results of Functional Bracing of Humeral Shaft Fractures: A Multicenter Retrospective Analysis. J Orthop Trauma. 2020;34(4):206–9.CrossRef

53.

Mw G, Testroote M, Jw M, Hmj J. Surgical versus non-surgical interventions for treating humeral shaft fractures in adults. Review. 2012;(1).

54.

Ekholm R, Adami J, Tidermark J, Hansson K, Törnkvist H, Ponzer S. Fractures of the shaft of the humerus. An epidemiological study of 401 fractures. J Bone Jt Surg - Ser B. 2006;88(11):1469–73.CrossRef

55.

Lee A, Weintraub S, Xi IL, Ahn J, Bernstein J. Predicting life expectancy after geriatric hip fracture: A systematic review. PLoS One [Internet]. 2021;16(12):e0261279. Available from: https://doi.org/10.1371/journal.pone.0261279

56.

Pollard TG, Gupta P, Quan T, Ramamurti P, Manzi JE, Fassihi SC, et al. Mortality and morbidity following operative management of tibial shaft fractures in octogenarians. Eur J Orthop Surg Traumatol [Internet]. 2022;(0123456789). Available from: https://doi.org/10.1007/s00590-021-03180-0

57.

Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm , shoulder and hand ( DASH ) outcome questionnaire : longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003;6:1–6.

58.

Toivanen JAK, Nieminen J, Laine HJ, Honkonen SE, Järvinen MJ. Functional treatment of closed humeral shaft fractures. Int Orthop. 2005;29(1):10–3.CrossRef

59.

Koch PP, Gross DFL, Gerber C. The results of functional ( Sarmiento ) bracing of humeral shaft fractures. J Shoulder Elbow Surg:143–50.

60.

Dekker AP, Chuttha S, Tambe AA, Clark DI. Predicting the Behaviour of Humeral Shaft Fractures: An Independent Validation Study of the Radiographic Union Score for HUmeral Fractures (RUSHU) and Value of Assessing Fracture Mobility. J Orthop Trauma. 2021.

61.

Sarmiento A, Kinman PB, Galvin EG, Schmitt RH, Phillips JG. Functional bracing of fractures of the shaft of the humerus. J Bone Joint Surg Am. 1977 Jul;59(5):596–601.CrossRef

62.

Van Lieshout EMM, Mahabier KC, Tuinebreijer WE, Verhofstad MHJ, Den Hartog D, Bolhuis HW, et al. Rasch analysis of the Disabilities of the Arm, Shoulder and Hand (DASH) instrument in patients with a humeral shaft fracture. J Shoulder Elb Surg. 2020;29(5):1040–9.CrossRef

63.

Terwee CB, Prinsen CAC, Chiarotto A, De Vet HCW, Westerman MJ, Patrick DL, et al. COSMIN standards and criteria for evaluating the content validity of health-related Patient-Reported Outcome Measures: a Delphi study. Qual Life Res. 2018;27:1159–70.CrossRef

64.

ICMJE Recommendation for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals. 2019; Available from: http://www.icmje.org/recommendations/

65.

World Medical Association. Declaration of Helsinki, Ethical Principles for Scientific Requirements and Research Protocols. Bull World Health Organ [Internet]. 2013;79(4):373 Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/.

Title: 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
Authors: Dennis Karimi
Stig Brorson
Kaare S. Midtgaard
Tore Fjalestad
Aksel Paulsen
Per Olerud
Carl Ekholm
Olof Wolf
Bjarke Viberg
SHAFT Collaborators
Publication date: 01-12-2022
Publisher: BioMed Central
Keyword: Humeral Shaft Fracture
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06317-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

Evaluation of an adaptive, multimodal intervention to reduce postoperative infections following cesarean delivery in Ethiopia: study protocol of the CLEAN-CS cluster-randomized stepped wedge interventional trial

Differentiated prevention and care to reduce the risk of HIV acquisition and transmission among female sex workers in Zimbabwe: study protocol for the ‘AMETHIST’ cluster randomised trial

The CHARTER-Ireland trial: can nebulised heparin reduce acute lung injury in patients with SARS-CoV-2 requiring advanced respiratory support in Ireland: a study protocol and statistical analysis plan for a randomised control trial

Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents (the TECTO trial): a statistical analysis plan for the randomised clinical trial

Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms

Placental growth fActor Repeat sampling for Reduction of adverse perinatal Outcomes in women with suspecTed pre-eclampsia: study protocol for a randomised controlled trial (PARROT-2)