NCT04574336

Brief Summary

This pragmatic multicenter randomized controlled trial (RCT) includes adult participants with an acute humeral shaft fracture to compare surgical fixation of humeral shaft fracture to non-surgical treatment with early identification and treatment of delayed union by a patient-reported outcome after 52 weeks. The trial population of 287 participants The trial population is divided in two age-groups due to the changes in DASH score by age. The definition of delayed union differs in the young and elderly population to consider dissimilarity in bone healing rates and the timepoint for crossover is therefor different between the groups. Participants will be randomized 1:1 between non-surgical treatment and surgical treatment. 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 earlier than 52 weeks, EQ-5D-5L, pain assessed by visual analogue 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, other major adverse events and mortality. SHAFT will provide information on the effectiveness of two standard treatments for humeral shaft fractures, while taking the dilemmas within the population into account.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for not_applicable

Timeline
64mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
4 countries

22 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Apr 2022Jul 2031

First Submitted

Initial submission to the registry

September 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2031

Expected
Last Updated

April 16, 2024

Status Verified

June 1, 2023

Enrollment Period

3.7 years

First QC Date

September 28, 2020

Last Update Submit

April 15, 2024

Conditions

Fracture Humerus of Shaft

Keywords

Humeral shaft fractureDiaphysisFracture fixationFracture HealingAgedRandomized Controlled TrialComparative study

Outcome Measures

Primary Outcomes (1)

  • Disabilities of the Arm, Shoulder and Hand (DASH) score

    A patient-reported outcome measure specific for physical function and symptoms of the upper limb (Disability of Arm, Shoulder and Hand-DASH). Scores range from 0 (no disability) to 100 (most severe disability)

    52 weeks

Secondary Outcomes (7)

  • EuroQol-5 Domain (EQ-5D-5L)

    Pre-Injury, 6 weeks, 12 weeks, 26 weeks, 52 weeks

  • Rate of complications

    Up to 52 weeks

  • Visual Analogue Scale (VAS)

    Baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks

  • Anchor question

    6 weeks, 12 weeks, 26 weeks, 52 weeks

  • Constant-Murley score

    6 weeks, 12 weeks, 26 weeks, 52 weeks

  • +2 more secondary outcomes

Other Outcomes (6)

  • Disabilities of the Arm, Shoulder and Hand (DASH) score

    2 years, 5 years

  • EuroQol-5 Domain (EQ-5D-5L)

    2 years, 5 years

  • Radiological measurements

    Baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks

  • +3 more other outcomes

Study Arms (2)

Surgical Treatment

EXPERIMENTAL

Primary surgery of humeral shaft fracture with surgeons choice of osteosynthesis method

Procedure: Surgical treatment

Non-surgical treatment

ACTIVE COMPARATOR

Treatment of humeral shaft fracture with sling and/or functional brace

Device: Non-surgical treatment

Interventions

Surgical treatmentPROCEDURE

We anticipate that surgical treatment will include plate osteosynthesis (MIPO and ORIF), intramedullary nailing (antegrade and retrograde) and external fixation. Plate and nail types, screw configuration and surgical approaches will be decided by the surgeon. The procedure will be conducted or supervised by a senior consultant.

Surgical Treatment
Non-surgical treatmentDEVICE

Non-surgical treatment will include sugar tong, splint, plaster splints, hanging casts, or functional bracing as the Sarmiento brace and will be worn until a surgeon removes it. If the surgeon deems it appropriate, participants will be offered to undergo early secondary surgery with a surgical procedure of their choice. The participants will be recorded and the reason will be noted. We anticipate the surgical procedures will be similar to the previous mentioned and perhaps with the addition of bone graft.

Non-surgical treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Inability to give informed consent
  • Undisplaced shaft fracture (less than a cortex-wide displacement in all radiographic plane)
  • Vascular injury in ipsilateral arm
  • Polytrauma (defined as a trauma with one or more concurrent fractures to the upper extremities or other trauma absolute indications for surgical intervention)
  • Pathological fracture
  • Open fracture
  • BMI \> 40
  • Health conditions preventing either treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Aabenraa Hospital

Aabenraa, Denmark

RECRUITING

Aarhus Hospital

Aarhus, Denmark

RECRUITING

Bispebjerg Hospital

Copenhagen, Denmark

RECRUITING

Hvidovre Hospital

Copenhagen, Denmark

RECRUITING

Esbjerg Hospital

Esbjerg, Denmark

RECRUITING

Aalborg-Farsø Hospital

Farsø, Denmark

RECRUITING

Herlev-Gentofte Hospital

Gentofte Municipality, Denmark

RECRUITING

New North Zealand Hospital

Hillerød, Denmark

RECRUITING

Holbæk Hospital

Holbæk, Denmark

RECRUITING

Kolding Hospital

Kolding, Denmark

RECRUITING

Zealand University

Køge, 4600, Denmark

RECRUITING

Odense Hospital

Odense, Denmark

RECRUITING

Slagelse Hospital

Slagelse, Denmark

RECRUITING

Viborg Regional Hospital

Viborg, 8000, Denmark

RECRUITING

Helsinki University Hospital

Helsinki, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

RECRUITING

Oslo University Hospital (Ullevål)

Oslo, Norway

RECRUITING

Stanvanger University Hospital

Stavanger, Norway

RECRUITING

Danderyd University Hospital

Stockholm, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Umeå University Hospital

Umeå, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

Related Publications (20)

  • Kim SH, Szabo RM, Marder RA. Epidemiology of humerus fractures in the United States: nationwide emergency department sample, 2008. Arthritis Care Res (Hoboken). 2012 Mar;64(3):407-14. doi: 10.1002/acr.21563.

    PMID: 22162357BACKGROUND

  • Ekholm R, Adami J, Tidermark J, Hansson K, Tornkvist H, Ponzer S. Fractures of the shaft of the humerus. An epidemiological study of 401 fractures. J Bone Joint Surg Br. 2006 Nov;88(11):1469-73. doi: 10.1302/0301-620X.88B11.17634.

    PMID: 17075092BACKGROUND

  • Gosler MW, Testroote M, Morrenhof JW, Janzing HM. Surgical versus non-surgical interventions for treating humeral shaft fractures in adults. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD008832. doi: 10.1002/14651858.CD008832.pub2.

    PMID: 22258990BACKGROUND

  • Harkin FE, Large RJ. Humeral shaft fractures: union outcomes in a large cohort. J Shoulder Elbow Surg. 2017 Nov;26(11):1881-1888. doi: 10.1016/j.jse.2017.07.001.

    PMID: 29054684BACKGROUND

  • Matsunaga FT, Tamaoki MJ, 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 Joint Surg Am. 2017 Apr 5;99(7):583-592. doi: 10.2106/JBJS.16.00628.

    PMID: 28375891BACKGROUND

  • van Middendorp JJ, 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. Eur J Trauma Emerg Surg. 2011 Jun;37(3):287-96. doi: 10.1007/s00068-011-0099-0. Epub 2011 Apr 1.

    PMID: 21837261BACKGROUND

  • Gottschalk MB, Carpenter W, Hiza E, Reisman W, Roberson J. Humeral Shaft Fracture Fixation: Incidence Rates and Complications as Reported by American Board of Orthopaedic Surgery Part II Candidates. J Bone Joint Surg Am. 2016 Sep 7;98(17):e71. doi: 10.2106/JBJS.15.01049.

    PMID: 27605696BACKGROUND

  • Ramo L, Sumrein BO, Lepola V, Lahdeoja T, Ranstam J, Paavola M, Jarvinen T, Taimela S; FISH Investigators. Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial. JAMA. 2020 May 12;323(18):1792-1801. doi: 10.1001/jama.2020.3182.

    PMID: 32396179BACKGROUND

  • Hosseini Khameneh SM, Abbasian M, Abrishamkarzadeh H, Bagheri S, Abdollahimajd F, Safdari F, Rahimi-Dehgolan S. Humeral shaft fracture: a randomized controlled trial of nonoperative versus operative management (plate fixation). Orthop Res Rev. 2019 Sep 23;11:141-147. doi: 10.2147/ORR.S212998. eCollection 2019.

    PMID: 31576178BACKGROUND

  • Oliver WM, Carter TH, Graham C, White TO, Clement ND, Duckworth AD, Molyneux SG. 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. Trials. 2019 Aug 5;20(1):475. doi: 10.1186/s13063-019-3576-0.

    PMID: 31383027BACKGROUND

  • Kurup H, Hossain M, Andrew JG. Dynamic compression plating versus locked intramedullary nailing for humeral shaft fractures in adults. Cochrane Database Syst Rev. 2011 Jun 15;2011(6):CD005959. doi: 10.1002/14651858.CD005959.pub2.

    PMID: 21678350BACKGROUND

  • 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 Dec;31(12):657-662. doi: 10.1097/BOT.0000000000000960.

    PMID: 28708781BACKGROUND

  • Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.

    PMID: 23303884BACKGROUND

  • 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 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.

    PMID: 25956159BACKGROUND

  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

    PMID: 18929686BACKGROUND

  • Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.

    PMID: 8773720BACKGROUND

  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PMID: 10109801BACKGROUND

  • 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. 2020 May;189:13-23. doi: 10.1016/j.thromres.2020.02.018. Epub 2020 Feb 20.

    PMID: 32135385BACKGROUND

  • Mahabier KC, Den Hartog D, Theyskens N, Verhofstad MHJ, Van Lieshout EMM; HUMMER Trial Investigators. 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 Elbow Surg. 2017 Jan;26(1):e1-e12. doi: 10.1016/j.jse.2016.07.072. Epub 2016 Oct 10.

    PMID: 27745806BACKGROUND

  • Karimi D, Brorson S, Midtgaard KS, Fjalestad T, Paulsen A, Olerud P, Ekholm C, Wolf O, Viberg B; SHAFT Collaborators. 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. Trials. 2022 Jun 2;23(1):453. doi: 10.1186/s13063-022-06317-6.

    PMID: 35655280DERIVED

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Bjarke Viberg, MD, PhD

    Hospital Lillebaelt

    STUDY CHAIR

Central Study Contacts

Dennis Karimi, M.D

CONTACT

+45 76363400denniskarimi@gmail.com

Bjarke Viberg, MD, PhD

CONTACT

+45 76363067

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 5, 2020

Study Start

April 4, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

July 31, 2031

Last Updated

April 16, 2024

Record last verified: 2023-06

Locations

NO(2)FI(2)SE(4)DK(14)