Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
287 participants
INTERVENTIONAL
2022-04-04
2031-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly
NCT03531463
Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus
NCT00835562
Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years
NCT06416618
Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion
NCT05574582
Rehabilitation Following Displaced Proximal Humerus Fractures
NCT05302089
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Null-hypothesis:
The DASH score at 52 weeks after surgical treatment is not superior to non-surgical treatment with the option of early crossover surgery in patients with humeral shaft fractures
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:
1. SHAFT-Y for the young with an age cut-off of 18 to 64 years. The early identification and treatment of delayed union is set to 6 to 12 weeks
2. SHAFT-E for the elder with an age cut-off +65 years. The early identification and treatment of delayed union is set to 12 to 26 weeks
Sites from Denmark, Sweden and Norway have been recruited and spans from academic level I to level III trauma centers
287 patients (n=163 for SHAFT-Y, n=124 for SHAFT-E) with a humeral shaft fracture will be equally randomized to surgical treatment or non-surgical treatment in each group.
Patients admitted to the emergency department in one of the trial sites and fulfil the eligibility criteria, will be invited to enroll into the trial. They will be given time to consider and be scheduled for a consultation with a trial worker within 10 days. If written consent is obtained at the consultation, randomization will occur immediately after.
Treatment will be performed within 14 days after injury
* Surgical treatment. The specific treatment is decided by the treating surgeon/department
* Non-surgical treatment with the option of early secondary surgery from 6-12 weeks for SHAFT-Y and 12-26 weeks for SHAFT-E
Patients can be offered to undergo early crossover fixation with a surgical procedure of the surgeon's choice, if one of these criteria are met:
* Unacceptable pain experienced by the patient
* Severe pain with gross instability of the fracture site assessed by:
* Unable to en bloc elevate the arm due to clear fracture instability
* Gentle manipulation of the fracture site. Gentle manipulation should respect the risk of callus breakage
* Severe problems tolerating the brace, e.g. discomfort, skin irritation, wounds, hygiene problems.
The patients that undergo early crossover surgery will have the reason for crossover thoroughly noted. We anticipate the surgical procedures will be similar to the ones previously mentioned with the possible addition of bone graft.
A computerized database software, Research Electronic Data Capture (REDCap) will be used to generate an irreversible random allocation sequence and perform block randomization with selected block sized of 2 and 4, which will be stratified on site and age (18-64 and +65). Patients will be assigned to the trial with an allocation of 1:1 to either surgical treatment or non-surgical treatment. The trial worker acquires the allocated treatment from the central coordinator with randomization rights to REDCap. The trial worker then initiates the treatment, either by scheduling the surgery date or applying the chosen non-surgical method.
The two groups (SHAFT-Y and SHAFT-E) require individual sample size calculations. Two standard deviations (SDs) were obtained from the data of the FISH trial(13) and were separated in age groups of 18-64 years and 65 years and above. By the distribution-based approach, one half a SD corresponds to the minimal important change (MIC). The calculations are powered to detect a MIC of 7 points in the young and 10 points in the elderly group in DASH, respectively. Two independent means sample size calculation were performed. For SHAFT-Y the following data were included: Mean difference= 7.0, SD= 14.91, α= 0.05 and power= 0.8. For SHAFT-E the following data were included: Mean difference= 10.0, SD= 18.59, α= 0.05 and power= 0.8. Based on the preceding assumptions and including an attrition of 15%, the total sample size is estimated to 163 patients for SHAFT-Y and 124 patients for SHAFT-E.
Primary analysis Descriptive statistics will be used to report demographic data. Demographic data and outcome measures will be tested visually and statistically (i.e. Shapiro Wilks test). Numeric variables will be summarized by means, standard deviations and 95% confidence intervals (95% CI). Median and interquartile ranges will be used when normal distribution is not met. Categorical variables will be summarized by frequency and proportion. For group comparison with numerical data, a student's t-test will be used if data is normally distributed, otherwise a non-parametric test will be used. For categorical data a Chi-square test will be used for group comparison. An intention-to-treat (ITT) analysis of the primary outcome will be conducted by univariable linear regression, including all patients that do not meet the withdrawal criteria and will be conducted to minimize bias within results. A sensitivity analysis will test the effects of non-adherence to protocol by conducting a per-protocol analysis and includes only patients who comply with the protocol. For missing data points in an outcome measure, a multiple imputation analysis using predictive covariates (age, sex, smoking, alcohol, UCLA activity, ASA grade)(50-52) will be conducted to deal with nonresponse bias. For comparison we will carry out a sensitivity analysis excluding all the missing values.
Data will be considered statistically significant if p-values \< 0.0471.
Secondary analysis In order to validate data a linear regression analysis will be computed with DASH score as the dependent variable and treatment modality as the independent variable. Additional regression analysis will be carried out between the early crossover group and the primary treatments. A multivariate regression analysis will be conducted to adjust for potential confounders. Variables adjusted for are: age, sex, smoking, alcohol, UCLA activity, ASA grade. Furthermore, we will analyze the longitudinal observations by applying a linear mixed effects regression model, including modality and time as well as a modality-time interaction as fixed effects and a random intercept for each patient. Data will be summarized as coefficients with 95% CIs and variance will be summarized as r-squares, adjusted r-squares, predicted r-squares, standard errors. Coefficients will be considered statistically significant if p-values \< 0.05.
Outcome timepoints Subjective and objective outcome measures will be obtained at following time points: pre-injury, baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks, 2 years and 5 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Surgical Treatment
Primary surgery of humeral shaft fracture with surgeons choice of osteosynthesis method
Surgical treatment
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.
Non-surgical treatment
Treatment of humeral shaft fracture with sling and/or functional brace
Non-surgical treatment
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Surgical treatment
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.
Non-surgical treatment
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
2. Undisplaced shaft fracture (less than a cortex-wide displacement in all radiographic plane)
3. Vascular injury in ipsilateral arm
4. Polytrauma (defined as a trauma with one or more concurrent fractures to the upper extremities or other trauma absolute indications for surgical intervention)
5. Pathological fracture
6. Open fracture
7. BMI \> 40
8. Health conditions preventing either treatment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Copenhagen University Hospital, Hvidovre
OTHER
Zealand University Hospital
OTHER
Oslo University Hospital
OTHER
Helse Stavanger HF
OTHER_GOV
Sahlgrenska University Hospital
OTHER
Uppsala University Hospital
OTHER
Odense University Hospital
OTHER
Hospital of Southern Jutland
OTHER
Slagelse Hospital
OTHER
Aalborg University Hospital
OTHER
University Hospital, Umeå
OTHER
Nordsjaellands Hospital
OTHER
Holbaek Sygehus
OTHER
Aarhus University Hospital
OTHER
Copenhagen University Hospital at Herlev
OTHER
University Hospital Bispebjerg and Frederiksberg
OTHER
Viborg Regional Hospital
OTHER
Karolinska University Hospital
OTHER
Danderyd Hospital
OTHER
Tampere University Hospital
OTHER
Helsinki University Central Hospital
OTHER
Kolding Sygehus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bjarke Viberg, MD, PhD
Role: STUDY_CHAIR
Hospital Lillebaelt
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aabenraa Hospital
Aabenraa, , Denmark
Aarhus Hospital
Aarhus, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Hvidovre Hospital
Copenhagen, , Denmark
Esbjerg Hospital
Esbjerg, , Denmark
Aalborg-Farsø Hospital
Farsø, , Denmark
Herlev-Gentofte Hospital
Gentofte Municipality, , Denmark
New North Zealand Hospital
Hillerød, , Denmark
Holbæk Hospital
Holbæk, , Denmark
Kolding Hospital
Kolding, , Denmark
Zealand University
Køge, , Denmark
Odense Hospital
Odense, , Denmark
Slagelse Hospital
Slagelse, , Denmark
Viborg Regional Hospital
Viborg, , Denmark
Helsinki University Hospital
Helsinki, , Finland
Tampere University Hospital
Tampere, , Finland
Oslo University Hospital (Ullevål)
Oslo, , Norway
Stanvanger University Hospital
Stavanger, , Norway
Danderyd University Hospital
Stockholm, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Umeå University Hospital
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Bjarke Viberg, MD, PhD
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jesper Schønnemann, M.D
Role: primary
Per Gundtoft, M.D.
Role: primary
Michael Kuhlmann, M.D
Role: primary
Søren Kring, M.D
Role: primary
Jens Knak
Role: primary
Esben Pedersen, M.D
Role: primary
Anne-Marie Nyholm
Role: primary
Peter Siesing-Mejer, M.D
Role: primary
Jacob Lagoni, M.D
Role: primary
Rasmus Bendtson, M.D.
Role: primary
Bamo Jalal, M.D
Role: primary
Joakim Jensen, M.D
Role: primary
Mads Vinding, M.D
Role: primary
Srdjan Zivanovic, M.D
Role: primary
Maire Ratasvuori, M.D., PhD.
Role: primary
Antti Launonen, M.D, PhD
Role: primary
Tore Fjalestad, M.D:
Role: primary
Aksel Paulsen, M.D.
Role: primary
Max Gordon, M.D.
Role: primary
Yan Li, M.D.
Role: primary
Jonas Sundkvist, M.D.
Role: primary
Olof Wolf, M.D.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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;(6):CD005959. doi: 10.1002/14651858.CD005959.pub2.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHAFT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.